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Immunogenicity of GSKs' MMR Vaccine (209762) vs. M-M-R® II, When Given With Routine Vaccines at 12-15 Months of Age

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00861744
Recruitment Status : Completed
First Posted : March 13, 2009
Results First Posted : November 4, 2011
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Rubella
Mumps
Measles
Measles-Mumps-Rubella Vaccine
Interventions Biological: GSK Biological's investigational vaccine 209762
Biological: M-M-R® II (Merck and Co)
Biological: Varivax®
Biological: Havrix®
Biological: Prevnar®
Enrollment 1259
Recruitment Details The study was divided in 3 phases: the active phase (up to Day 42), the extended safety follow-up (ESFU) phase (up to Day 180) and the antibody persistence phase (up to Day 730).
Pre-assignment Details The number of subjects enrolled was 1259. 39 subjects were enrolled in the study but did not receive a subject number and were never vaccinated.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines. Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines. Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines. Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Period Title: Overall Study
Started 304 304 304 308
Completed 287 275 280 275
Not Completed 17 29 24 33
Reason Not Completed
Adverse Event             0             0             0             1
Lost to Follow-up             7             19             17             12
Withdrawal by Subject             10             6             6             19
Protocol Violation             0             1             0             0
Migration from study area             0             3             1             0
Blood draws             0             0             0             1
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group Total
Hide Arm/Group Description Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines. Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines. Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines. Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines. Total of all reporting groups
Overall Number of Baseline Participants 304 304 304 308 1220
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 304 participants 304 participants 304 participants 308 participants 1220 participants
12.4  (0.75) 12.4  (0.73) 12.2  (0.56) 12.4  (0.75) 12.4  (0.70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 304 participants 304 participants 304 participants 308 participants 1220 participants
Female
156
  51.3%
144
  47.4%
157
  51.6%
139
  45.1%
596
  48.9%
Male
148
  48.7%
160
  52.6%
147
  48.4%
169
  54.9%
624
  51.1%
1.Primary Outcome
Title Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value.
Hide Description Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.
Time Frame At Day 42 after administration of a dose of Priorix vaccine.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 247 240 240 249
Measure Type: Number
Unit of Measure: Subjects
245 236 236 248
2.Primary Outcome
Title Number of Subjects With Anti-mumps Virus Antibody Titer Equal to or Above the Cut-off-value.
Hide Description Anti-mumps virus antibody cut-off-value assessed was ≥ 51 Estimated Dose 50 (ED50). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <24 ED50 prior to vaccination.
Time Frame At Day 42 after administration of a dose of Priorix vaccine.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 193 202 195 192
Measure Type: Number
Unit of Measure: Subjects
175 183 175 175
3.Primary Outcome
Title Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.
Hide Description Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL).
Time Frame At Day 42 after administration of a dose of Priorix vaccine.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 247 238 239 249
Measure Type: Number
Unit of Measure: Subjects
244 235 233 249
4.Secondary Outcome
Title Number of Subjects With Anti-varicella Antibody Concentration Equal to or Above the Cut-off-value.
Hide Description Anti-varicella virus antibody cut-off-value assessed was ≥ 75 milli-International Units per milliliter (mIU/mL).
Time Frame At Day 42 after administration of a dose of Varivax vaccine.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 245 238 240 246
Measure Type: Number
Unit of Measure: Subjects
240 230 230 241
5.Secondary Outcome
Title Anti-measles Virus Antibody Concentrations
Hide Description Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.
Time Frame At Day 42 after administration of a dose of Priorix vaccine.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 247 240 240 249
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
2798.7
(2544.8 to 3077.9)
2878.2
(2607.0 to 3177.7)
2593.1
(2350.3 to 2861.1)
2949.5
(2698.4 to 3224.0)
6.Secondary Outcome
Title Anti-mumps Virus Antibody Concentrations
Hide Description Antibody concentrations are expressed as Geometric Mean Titer (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody titer < 24 ED50 prior to vaccination.
Time Frame At Day 42 after administration of a dose of Priorix vaccine.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 193 202 195 192
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
242.0
(204.5 to 286.5)
265.0
(221.8 to 316.5)
253.4
(213.4 to 300.9)
267.6
(224.2 to 319.5)
7.Secondary Outcome
Title Anti-rubella Virus Antibody Concentrations
Hide Description Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.
Time Frame At Day 42 after administration of a dose of Priorix vaccine.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 247 238 239 249
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
72.2
(65.6 to 79.6)
77.7
(70.4 to 85.7)
68.2
(61.8 to 75.3)
89.4
(81.4 to 98.2)
8.Secondary Outcome
Title Anti-S. Pneumoniae Antibody Concentrations (by Serotype).
Hide Description Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL.
Time Frame At Day 42 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 128 127 128 126
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
Anti-S.PNEU-4
3.57
(3.04 to 4.20)
3.72
(3.21 to 4.31)
3.40
(2.88 to 4.00)
3.80
(3.17 to 4.56)
Anti-S. PNEU-6B
5.68
(4.78 to 6.76)
5.87
(5.02 to 6.87)
5.41
(4.66 to 6.28)
7.22
(6.28 to 8.29)
Anti-S.PNEU 9V
6.56
(5.66 to 7.60)
7.30
(6.35 to 8.38)
5.81
(4.97 to 6.78)
7.80
(6.81 to 8.93)
Anti-S.PNEU-14
9.23
(8.03 to 10.61)
8.33
(7.30 to 9.51)
7.58
(6.55 to 8.76)
7.97
(6.95 to 9.14)
Anti-S.PNEU-18 C
6.20
(5.30 to 7.26)
6.62
(5.76 to 7.60)
6.15
(5.25 to 7.21)
6.73
(5.74 to 7.91)
Anti-S.PNEU-19 F
2.42
(2.05 to 2.85)
2.46
(2.11 to 2.88)
2.34
(2.00 to 2.73)
2.59
(2.23 to 3.00)
Anti-S.PNEU-23 F
9.34
(7.76 to 11.25)
9.27
(7.82 to 10.99)
8.33
(6.88 to 10.10)
11.49
(9.67 to 13.66)
9.Secondary Outcome
Title Anti-varicella Antibody Concentrations.
Hide Description Antibody concentrations are expressed as Geometric Mean Titers (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody concentration < 25 mIU/mL prior to vaccination.
Time Frame At Day 42 after administration of a dose of Varivax vaccine.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 245 238 240 246
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
245.5
(229.0 to 263.3)
235.2
(217.4 to 254.4)
236.0
(218.0 to 255.5)
255.9
(240.4 to 272.4)
10.Secondary Outcome
Title Anti-hepatitis A Virus Antibody Concentrations.
Hide Description Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-hepatitis A virus antibody concentrations <15 mIU/mL prior to vaccination.
Time Frame At Day 42 after administration of a dose of Havrix vaccine.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 117 112 111 124
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
33.8
(28.8 to 39.6)
39.2
(33.1 to 46.5)
39.4
(32.7 to 47.5)
42.1
(35.8 to 49.6)
11.Secondary Outcome
Title Number of Subjects With Anti-hepatitis A Antibody Concentrations Equal to or Above the Cut-off-value.
Hide Description Anti-hepatitis A antibody cut-off-value assessed was ≥15 milli-International Units per milliliter (mIU/mL).
Time Frame At Day 42 after administration of a dose of Havrix vaccine.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 117 112 111 124
Measure Type: Number
Unit of Measure: Subjects
98 99 94 110
12.Secondary Outcome
Title Anti-S. Pneumoniae Antibody Concentrations (by Serotype).
Hide Description Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL.
Time Frame At Day 0 before vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 129 130 130 119
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
Anti-S.PNEU-4
0.54
(0.46 to 0.65)
0.61
(0.52 to 0.72)
0.67
(0.58 to 0.78)
0.67
(0.56 to 0.81)
Anti-S.PNEU-6B
0.53
(0.43 to 0.66)
0.57
(0.46 to 0.70)
0.52
(0.43 to 0.64)
0.67
(0.56 to 0.80)
Anti-S.PNEU-9V
1.01
(0.85 to 1.20)
1.13
(0.97 to 1.32)
1.04
(0.88 to 1.23)
1.26
(1.06 to 1.49)
Anti-S.PNEU-14
3.01
(2.60 to 3.47)
2.82
(2.42 to 3.28)
2.54
(2.21 to 2.92)
2.76
(2.38 to 3.20)
Anti-S.PNEU-18C
0.88
(0.74 to 1.03)
0.97
(0.83 to 1.13)
0.97
(0.83 to 1.14)
1.00
(0.86 to 1.15)
Anti-S.PNEU-19F
0.40
(0.32 to 0.50)
0.40
(0.33 to 0.50)
0.44
(0.36 to 0.53)
0.45
(0.37 to 0.56)
Anti-S.PNEU-23 F
0.64
(0.51 to 0.82)
0.63
(0.51 to 0.77)
0.65
(0.52 to 0.81)
0.85
(0.67 to 1.08)
13.Secondary Outcome
Title Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value
Hide Description Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL).
Time Frame At 1 year post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 213 215 218 210
Measure Type: Number
Unit of Measure: Subjects
211 211 218 209
14.Secondary Outcome
Title Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value
Hide Description Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL).
Time Frame At 2 years post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 171 159 169 166
Measure Type: Number
Unit of Measure: Subjects
171 159 168 166
15.Secondary Outcome
Title Anti-measles Virus Antibody Concentrations
Hide Description Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.
Time Frame At 2 years post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 171 159 169 166
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
3361.1
(2922.3 to 3865.6)
3963.8
(3479.3 to 4515.7)
3360.3
(2923.3 to 3862.7)
4022.1
(3507.7 to 4611.9)
16.Secondary Outcome
Title Anti-measles Virus Antibody Concentrations
Hide Description Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.
Time Frame At 1 year post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 213 215 218 210
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
3224.3
(2840.1 to 3660.5)
3708.2
(3226.2 to 4262.2)
3534.7
(3139.9 to 3979.1)
3828.1
(3371.3 to 4346.7)
17.Secondary Outcome
Title Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash and Varicella-like Rash.
Hide Description [Not Specified]
Time Frame During the 43-day (Days 0-42) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 283 275 283 277
Measure Type: Number
Unit of Measure: Subjects
Varicella like 0 4 0 0
Measles/Rubella like 6 7 5 5
18.Secondary Outcome
Title Number of Subjects Reporting Febrile Convulsions
Hide Description Timing of febrile convulsions: events occured on Day 29 in the Priorix 2 Group and Day 0 in the MMR II Group. All cases of febrile convulsions were case of meningism.
Time Frame During the 43-day (Days 0-42) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 283 275 283 277
Measure Type: Number
Unit of Measure: Subjects
0 1 0 1
19.Secondary Outcome
Title Anti-mumps Virus Antibody Titers (Enhanced Plaque Reduction Neutralization (PRN))
Hide Description Antibody titers were expressed as Geometric Mean Titer (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody titer < 24 ED50 prior to vaccination.
Time Frame At 1 year post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 189 186 189 183
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
162.8
(141.8 to 186.9)
188.3
(162.4 to 218.3)
176.2
(152.6 to 203.3)
185.5
(163.5 to 210.6)
20.Secondary Outcome
Title Number of Subjects Reporting Other Rash.
Hide Description Other rash = not confirmed by the investigator to be either measles/rubella-like or varicella-like in nature
Time Frame During the 43-day (Days 0-42) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 283 275 283 277
Measure Type: Number
Unit of Measure: Subjects
Localized or generalized 72 74 60 60
With fever 26 29 23 23
Grade 3 11 10 6 6
Related 9 14 6 6
21.Secondary Outcome
Title Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Enhanced PRN)
Hide Description Anti-mumps virus antibody cut-off-value assessed was ≥ 51 ED50.
Time Frame At 1 year post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 189 186 189 183
Measure Type: Number
Unit of Measure: Subjects
169 170 171 170
22.Secondary Outcome
Title Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.
Hide Description Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.
Time Frame At 1 year post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 213 214 218 210
Measure Type: Number
Unit of Measure: Subjects
212 213 217 210
23.Secondary Outcome
Title Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.
Hide Description Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL).
Time Frame At 2 years post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 171 158 168 166
Measure Type: Number
Unit of Measure: Subjects
171 158 168 166
24.Secondary Outcome
Title Anti-rubella Virus Antibody Concentrations
Hide Description Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.
Time Frame At 1 year post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 213 214 218 210
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
138.1
(125.3 to 152.2)
145.4
(132.0 to 160.1)
136.5
(123.5 to 150.9)
166.8
(151.5 to 183.6)
25.Secondary Outcome
Title Anti-rubella Virus Antibody Concentrations
Hide Description Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.
Time Frame At 2 years post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 171 158 168 166
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
78.0
(69.7 to 87.2)
79.5
(71.7 to 88.2)
81.7
(73.8 to 90.4)
93.1
(83.6 to 103.6)
26.Secondary Outcome
Title Number of Subjects Reporting Fever.
Hide Description fever is assessed for temperature ≥38°C/100.4°F and >39.5°C/103.1°F as measured rectally.
Time Frame During the 15-day (Days 0-14) and 43 days (Days 0-42) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 283 275 283 277
Measure Type: Number
Unit of Measure: Subjects
Day 15 (N= 283; 275; 283; 277) ≥38.0°C 65 79 64 56
Day 15 (N= 283; 275; 283; 277) >39.5°C 10 7 9 8
Day 43 (N= 283; 275; 283; 277) ≥38.0°C 103 104 104 85
Day 43 (N= 283; 275; 283; 277) >39.5°C 20 14 18 13
27.Secondary Outcome
Title Number of Subjects With Solicited Local Symptoms.
Hide Description Solicited local symptoms assessed were pain, redness and swelling.
Time Frame During the 4-day (Days 0-3) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 282 274 282 274
Measure Type: Number
Unit of Measure: Subjects
Pain 70 70 79 67
Redness 45 47 41 47
Swelling 20 26 19 15
28.Secondary Outcome
Title Number of Subjects Reporting Medically Attended Visit (MAEs)
Hide Description MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Time Frame During the 43-day (Days 0-42) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 304 304 304 308
Measure Type: Number
Unit of Measure: Subjects
99 99 97 107
29.Secondary Outcome
Title Number of Subjects With Unsolicited Adverse Events (AEs).
Hide Description An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time Frame During the 43-day (Days 0-42) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 304 304 304 308
Measure Type: Number
Unit of Measure: Subjects
170 153 164 169
30.Secondary Outcome
Title Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling.
Hide Description Swelling with accompanying general symptoms
Time Frame During the 43-day (Days 0-42) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 283 275 283 277
Measure Type: Number
Unit of Measure: Subjects
3 3 5 2
31.Secondary Outcome
Title Number of Subjects With Solicited General Symptoms.
Hide Description Assessed solicited general symptoms were drowsiness, irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.
Time Frame During the 15-day (Days 0-14) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 283 275 283 277
Measure Type: Number
Unit of Measure: Subjects
Any drowsiness 133 106 113 109
Any irritability 180 141 150 153
Any loss of appetite 111 77 110 94
32.Secondary Outcome
Title Number of Subjects Reporting New Onset Chronic Illnesses (NOCIs).
Hide Description NOCIs included autoimmune disorders, asthma, type I diabetes, allergies.
Time Frame From Day 0 to Day 180 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 304 304 304 308
Measure Type: Number
Unit of Measure: Subjects
5 2 4 2
33.Secondary Outcome
Title Number of Subjects Reporting Serious Adverse Events (SAEs)
Hide Description SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame From Day 0 to Day 180 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 304 304 304 308
Measure Type: Number
Unit of Measure: Subjects
1 6 7 9
34.Secondary Outcome
Title Number of Subjects Reporting Serious Adverse Events (SAEs).
Hide Description SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are congenital anomaly/birth defect in the offspring of a study subject.
Time Frame From Day 180 to Day 730 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 304 304 304 308
Measure Type: Number
Unit of Measure: Subjects
0 0 0 1
35.Secondary Outcome
Title Number of Subjects Reporting Conditions Prompting Emergency Room (ER) Visits.
Hide Description [Not Specified]
Time Frame From Day 0 to Day 180 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 304 304 304 308
Measure Type: Number
Unit of Measure: Subjects
27 28 22 26
36.Secondary Outcome
Title Anti-mumps Virus Antibody Titers (Unenhanced PRN)
Hide Description Antibody titers were expressed as Geometric Mean Titer (GMT).
Time Frame At 1 year post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 196 205 211 195
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
31.0
(24.1 to 39.9)
46.1
(36.2 to 58.7)
39.3
(31.0 to 50.0)
46.6
(36.6 to 59.3)
37.Secondary Outcome
Title Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN)
Hide Description Anti-mumps virus antibody cut-off-value assessed was ≥ 4 Estimated Dose 50 (ED50).
Time Frame At 1 year post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 196 205 211 195
Measure Type: Number
Unit of Measure: Subjects
173 186 184 173
38.Secondary Outcome
Title Anti-mumps Virus Antibody Titers (Unenhanced PRN)
Hide Description Antibody concentrations are expressed as Geometric Mean Titer (GMT).
Time Frame At 2 years post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 157 144 157 152
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
43.4
(33.4 to 56.3)
48.9
(37.7 to 63.5)
57.4
(45.7 to 72.2)
60.7
(47.6 to 77.5)
39.Secondary Outcome
Title Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN)
Hide Description Anti-mumps virus antibody cut-off-value assessed was ≥ 4 Estimated Dose 50 (ED50).
Time Frame At 2 years post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 157 144 157 152
Measure Type: Number
Unit of Measure: Subjects
144 134 152 144
40.Secondary Outcome
Title Anti-mumps Virus Antibody Concentrations (Pharmaceutical Product Development (PPD) ELISA)
Hide Description Antibody concentrations are expressed as Geometric Mean Concentrations (GMC) in ELISA units per milliliter (EU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <5 EU/mL prior to vaccination.
Time Frame At 1 year post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 170 173 179 170
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
47.3
(39.2 to 57.1)
42.9
(36.4 to 50.6)
42.5
(35.9 to 50.3)
58.6
(50.6 to 67.8)
41.Secondary Outcome
Title Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA)
Hide Description Anti-mumps virus antibody cut-off-value assessed was ≥ 10 ELISA units per milliliter (EU/mL)
Time Frame At 1 year post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 170 173 179 170
Measure Type: Number
Unit of Measure: Subjects
155 159 162 164
42.Secondary Outcome
Title Anti-mumps Virus Antibody Concentrations (PPD ELISA)
Hide Description Antibody concentrations are expressed as Geometric Mean Concentrations (GMC) in ELISA units per milliliter (EU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <5 EU/mL prior to vaccination.
Time Frame At 2 years post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 136 130 141 140
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
47.8
(40.2 to 56.9)
50.2
(42.1 to 59.9)
54.0
(46.1 to 63.3)
59.2
(50.1 to 70.0)
43.Secondary Outcome
Title Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA)
Hide Description Anti-mumps virus antibody cut-off-value assessed was ≥ 10 ELISA units per milliliter (EU/mL)
Time Frame At 2 years post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description:
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Number of Participants Analyzed 136 130 141 140
Measure Type: Number
Unit of Measure: Subjects
128 125 136 134
Time Frame Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730).
Adverse Event Reporting Description Solicited symptoms were only assessed on subjects returning the symptom sheet.
 
Arm/Group Title Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Hide Arm/Group Description Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines. Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines. Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines. Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
All-Cause Mortality
Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/304 (0.00%)      0/304 (0.00%)      0/304 (0.00%)      0/308 (0.00%)    
Hide Serious Adverse Events
Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/304 (0.33%)      7/304 (2.30%)      8/304 (2.63%)      10/308 (3.25%)    
Blood and lymphatic system disorders         
Idiopathic thrombocytopenic purpura * 1 [1]  0/304 (0.00%)  1/304 (0.33%)  0/304 (0.00%)  0/308 (0.00%) 
Leukocytosis * 1 [1]  0/304 (0.00%)  1/304 (0.33%)  0/304 (0.00%)  0/308 (0.00%) 
Lymphadenitis * 1 [1]  0/304 (0.00%)  0/304 (0.00%)  1/304 (0.33%)  0/308 (0.00%) 
Idiopathic thrombocytopenic purpura * 1 [2]  0/304 (0.00%)  1/304 (0.33%)  0/304 (0.00%)  0/308 (0.00%) 
Leukocytosis * 1 [2]  0/304 (0.00%)  1/304 (0.33%)  0/304 (0.00%)  0/308 (0.00%) 
Lymphadenitis * 1 [2]  0/304 (0.00%)  0/304 (0.00%)  1/304 (0.33%)  0/308 (0.00%) 
Gastrointestinal disorders         
Intussusception * 1 [1]  0/304 (0.00%)  0/304 (0.00%)  1/304 (0.33%)  0/308 (0.00%) 
Intussusception * 1 [2]  0/304 (0.00%)  0/304 (0.00%)  1/304 (0.33%)  0/308 (0.00%) 
General disorders         
Hypoxia * 1 [1]  0/304 (0.00%)  0/304 (0.00%)  0/304 (0.00%)  2/308 (0.65%) 
Inflenza like illness * 1 [1]  0/304 (0.00%)  0/304 (0.00%)  0/304 (0.00%)  1/308 (0.32%) 
Pyrexia * 1 [1]  0/304 (0.00%)  0/304 (0.00%)  1/304 (0.33%)  0/308 (0.00%) 
Influenza like illness * 1 [2]  0/304 (0.00%)  0/304 (0.00%)  0/304 (0.00%)  1/308 (0.32%) 
Pyrexia * 1 [2]  0/304 (0.00%)  0/304 (0.00%)  1/304 (0.33%)  0/308 (0.00%) 
Infections and infestations         
Bronchiolitis * 1 [1]  1/304 (0.33%)  1/304 (0.33%)  0/304 (0.00%)  2/308 (0.65%) 
Bronchitis * 1 [1]  0/304 (0.00%)  0/304 (0.00%)  1/304 (0.33%)  1/308 (0.32%) 
Pneumonia * 1 [1]  0/304 (0.00%)  0/304 (0.00%)  1/304 (0.33%)  1/308 (0.32%) 
Cellulitis * 1 [1]  0/304 (0.00%)  0/304 (0.00%)  1/304 (0.33%)  0/308 (0.00%) 
Coxsackie viral infection * 1 [1]  0/304 (0.00%)  0/304 (0.00%)  1/304 (0.33%)  0/308 (0.00%) 
Croup infectious * 1 [1]  0/304 (0.00%)  0/304 (0.00%)  0/304 (0.00%)  1/308 (0.32%) 
Gastroenteritis viral * 1 [1]  0/304 (0.00%)  0/304 (0.00%)  1/304 (0.33%)  0/308 (0.00%) 
H1N1 influenza * 1 [1]  0/304 (0.00%)  0/304 (0.00%)  0/304 (0.00%)  1/308 (0.32%) 
Influenza * 1 [1]  0/304 (0.00%)  0/304 (0.00%)  0/304 (0.00%)  1/308 (0.32%) 
Otitis media acute * 1 [1]  0/304 (0.00%)  0/304 (0.00%)  0/304 (0.00%)  1/308 (0.32%) 
Pharyngotonsillitis * 1 [1]  0/304 (0.00%)  0/304 (0.00%)  0/304 (0.00%)  1/308 (0.32%) 
Pneumonia respiratory syncytial viral * 1 [1]  0/304 (0.00%)  0/304 (0.00%)  0/304 (0.00%)  1/308 (0.32%) 
Rash * 1 [1]  0/304 (0.00%)  0/304 (0.00%)  0/304 (0.00%)  1/308 (0.32%) 
Respiratory syncitial virus infection * 1 [1]  0/304 (0.00%)  0/304 (0.00%)  0/304 (0.00%)  1/308 (0.32%) 
Staphylococcal infection * 1 [1]  0/304 (0.00%)  1/304 (0.33%)  0/304 (0.00%)  0/308 (0.00%) 
Upper respiratory tract infection * 1 [1]  0/304 (0.00%)  0/304 (0.00%)  0/304 (0.00%)  1/308 (0.32%) 
Urinary tract infection * 1 [1]  0/304 (0.00%)  0/304 (0.00%)  0/304 (0.00%)  1/308 (0.32%) 
Bronchiolitis * 1 [2]  1/304 (0.33%)  1/304 (0.33%)  0/304 (0.00%)  2/308 (0.65%) 
Bronchitis * 1 [2]  0/304 (0.00%)  0/304 (0.00%)  1/304 (0.33%)  1/308 (0.32%) 
Cellulitis * 1 [2]  0/304 (0.00%)  0/304 (0.00%)  1/304 (0.33%)  0/308 (0.00%) 
Coxsackie viral infection * 1 [2]  0/304 (0.00%)  0/304 (0.00%)  1/304 (0.33%)  0/308 (0.00%) 
Gastroenteritis viral * 1 [2]  0/304 (0.00%)  0/304 (0.00%)  1/304 (0.33%)  0/308 (0.00%) 
H1N1 influenza * 1 [2]  0/304 (0.00%)  0/304 (0.00%)  0/304 (0.00%)  1/308 (0.32%) 
Influenza * 1 [2]  0/304 (0.00%)  0/304 (0.00%)  0/304 (0.00%)  1/308 (0.32%) 
Pharyngotonsillitis * 1 [2]  0/304 (0.00%)  0/304 (0.00%)  0/304 (0.00%)  1/308 (0.32%) 
Pneumonia * 1 [2]  0/304 (0.00%)  0/304 (0.00%)  1/304 (0.33%)  1/308 (0.32%) 
Pneumonia respiratory syncytial viral * 1 [2]  0/304 (0.00%)  0/304 (0.00%)  0/304 (0.00%)  1/308 (0.32%) 
Respiratory syncytial virus infection * 1 [2]  0/304 (0.00%)  0/304 (0.00%)  0/304 (0.00%)  1/308 (0.32%) 
Staphylococcal infection * 1 [2]  0/304 (0.00%)  1/304 (0.33%)  0/304 (0.00%)  0/308 (0.00%) 
Upper respiratory tract infection * 1 [2]  0/304 (0.00%)  0/304 (0.00%)  0/304 (0.00%)  1/308 (0.32%) 
Urinary tract infection * 1 [2]  0/304 (0.00%)  0/304 (0.00%)  0/304 (0.00%)  1/308 (0.32%) 
Injury, poisoning and procedural complications         
Thermal burn * 1 [1]  0/304 (0.00%)  0/304 (0.00%)  1/304 (0.33%)  0/308 (0.00%) 
Musculoskeletal and connective tissue disorders         
Ataxia * 1 [1]  0/304 (0.00%)  1/304 (0.33%)  0/304 (0.00%)  0/308 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Nephroblastoma * 1 [3]  0/304 (0.00%)  0/304 (0.00%)  0/304 (0.00%)  1/308 (0.32%) 
Nervous system disorders         
Febrile convulsion * 1 [1]  0/304 (0.00%)  0/304 (0.00%)  0/304 (0.00%)  1/308 (0.32%) 
Ataxia * 1 [2]  0/304 (0.00%)  1/304 (0.33%)  0/304 (0.00%)  0/308 (0.00%) 
Febrile convulsion * 1 [2]  0/304 (0.00%)  0/304 (0.00%)  0/304 (0.00%)  1/308 (0.32%) 
Respiratory, thoracic and mediastinal disorders         
Asthma * 1 [1]  0/304 (0.00%)  1/304 (0.33%)  0/304 (0.00%)  0/308 (0.00%) 
Nasal congestion * 1 [1]  0/304 (0.00%)  0/304 (0.00%)  0/304 (0.00%)  1/308 (0.32%) 
Bronchial hyperreactivity * 1 [1]  0/304 (0.00%)  0/304 (0.00%)  0/304 (0.00%)  1/308 (0.32%) 
Bronchial hyperreactivity * 1 [2]  0/304 (0.00%)  0/304 (0.00%)  0/304 (0.00%)  1/308 (0.32%) 
Hypoxia * 1 [2]  0/304 (0.00%)  0/304 (0.00%)  0/304 (0.00%)  2/308 (0.65%) 
Nasal congestion * 1 [2]  0/304 (0.00%)  0/304 (0.00%)  0/304 (0.00%)  1/308 (0.32%) 
Skin and subcutaneous tissue disorders         
Petechiae * 1 [1]  0/304 (0.00%)  0/304 (0.00%)  1/304 (0.33%)  0/308 (0.00%) 
Petechiae * 1 [2]  0/304 (0.00%)  0/304 (0.00%)  1/304 (0.33%)  0/308 (0.00%) 
Rash * 1 [2]  0/304 (0.00%)  0/304 (0.00%)  0/304 (0.00%)  1/308 (0.32%) 
Vascular disorders         
Extremity necrosis * 1 [1]  0/304 (0.00%)  1/304 (0.33%)  0/304 (0.00%)  0/308 (0.00%) 
Extremity necrosis * 1 [2]  0/304 (0.00%)  1/304 (0.33%)  0/304 (0.00%)  0/308 (0.00%) 
1
Term from vocabulary, MedDRA 16.0
*
Indicates events were collected by non-systematic assessment
[1]
Numbers correspond to all available data at the time of analysis of the active phase of the study.
[2]
From the beginning of the study (Day 0) up to Day 180.
[3]
SAE reported between Day 180 and Day 730 post-vaccination.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   240/304 (78.95%)      216/304 (71.05%)      219/304 (72.04%)      221/308 (71.75%)    
Blood and lymphatic system disorders         
Anaemia † 1  0/304 (0.00%)  0 1/304 (0.33%)  1 1/304 (0.33%)  1 2/308 (0.65%)  2
Iron deficiency anaemia † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 1/304 (0.33%)  1 1/308 (0.32%)  1
Leukocytosis † 1  1/304 (0.33%)  1 0/304 (0.00%)  0 0/304 (0.00%)  0 1/308 (0.32%)  1
Lymphadenopathy † 1  1/304 (0.33%)  1 0/304 (0.00%)  0 1/304 (0.33%)  1 2/308 (0.65%)  2
Congenital, familial and genetic disorders         
Laryngomalacia † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 0/304 (0.00%)  0 1/308 (0.32%)  1
Ear and labyrinth disorders         
Auricular pseudocyst † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 0/304 (0.00%)  0 1/308 (0.32%)  1
Cerumen impaction † 1  0/304 (0.00%)  0 1/304 (0.33%)  1 2/304 (0.66%)  2 2/308 (0.65%)  2
Ear pain † 1  1/304 (0.33%)  1 1/304 (0.33%)  1 3/304 (0.99%)  3 2/308 (0.65%)  2
Eustachian tube dysfunction † 1  0/304 (0.00%)  0 1/304 (0.33%)  1 0/304 (0.00%)  0 0/308 (0.00%)  0
Tympanic membrane perforation † 1  1/304 (0.33%)  1 0/304 (0.00%)  0 0/304 (0.00%)  0 0/308 (0.00%)  0
Eye disorders         
Conjunctivitis † 1  9/304 (2.96%)  9 3/304 (0.99%)  3 0/304 (0.00%)  0 4/308 (1.30%)  4
Dark circles under eyes † 1  1/304 (0.33%)  1 0/304 (0.00%)  0 0/304 (0.00%)  0 0/308 (0.00%)  0
Eye allergy † 1  0/304 (0.00%)  0 1/304 (0.33%)  2 0/304 (0.00%)  0 0/308 (0.00%)  0
Eye swelling † 1  0/304 (0.00%)  0 1/304 (0.33%)  2 0/304 (0.00%)  0 0/308 (0.00%)  0
Lacrimation increased † 1  1/304 (0.33%)  1 0/304 (0.00%)  0 0/304 (0.00%)  0 1/308 (0.32%)  1
Gastrointestinal disorders         
Abdominal discomfort † 1  0/304 (0.00%)  0 1/304 (0.33%)  1 0/304 (0.00%)  0 0/308 (0.00%)  0
Abdominal distension † 1  0/304 (0.00%)  0 1/304 (0.33%)  1 0/304 (0.00%)  0 0/308 (0.00%)  0
Abdominal pain upper † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 1/304 (0.33%)  1 0/308 (0.00%)  0
Aphthous stomatitis † 1  0/304 (0.00%)  0 1/304 (0.33%)  1 0/304 (0.00%)  0 0/308 (0.00%)  0
Bowel movement irregularity † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 0/304 (0.00%)  0 1/308 (0.32%)  1
Colitis † 1  1/304 (0.33%)  1 0/304 (0.00%)  0 0/304 (0.00%)  0 0/308 (0.00%)  0
Constipation † 1  3/304 (0.99%)  3 1/304 (0.33%)  1 4/304 (1.32%)  5 3/308 (0.97%)  3
Diarrhoea † 1  25/304 (8.22%)  29 24/304 (7.89%)  29 19/304 (6.25%)  21 21/308 (6.82%)  22
Diarrhoea haemorrhagic † 1  0/304 (0.00%)  0 1/304 (0.33%)  1 0/304 (0.00%)  0 0/308 (0.00%)  0
Dysphagia † 1  1/304 (0.33%)  1 0/304 (0.00%)  0 0/304 (0.00%)  0 0/308 (0.00%)  0
Enteritis † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 1/304 (0.33%)  1 0/308 (0.00%)  0
Faeces discoloured † 1  0/304 (0.00%)  0 1/304 (0.33%)  1 0/304 (0.00%)  0 0/308 (0.00%)  0
Flatulence † 1  2/304 (0.66%)  3 1/304 (0.33%)  1 2/304 (0.66%)  3 2/308 (0.65%)  2
Gastritis † 1  1/304 (0.33%)  1 1/304 (0.33%)  1 0/304 (0.00%)  0 0/308 (0.00%)  0
Gastrooesophageal reflux disease † 1  1/304 (0.33%)  1 0/304 (0.00%)  0 0/304 (0.00%)  0 0/308 (0.00%)  0
Proctalgia † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 1/304 (0.33%)  1 0/308 (0.00%)  0
Stomatitis † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 1/304 (0.33%)  1 0/308 (0.00%)  0
Teething † 1  35/304 (11.51%)  40 35/304 (11.51%)  41 37/304 (12.17%)  47 35/308 (11.36%)  40
Tongue disorder † 1  1/304 (0.33%)  1 0/304 (0.00%)  0 0/304 (0.00%)  0 0/308 (0.00%)  0
Tooth discolouration † 1  1/304 (0.33%)  1 2/304 (0.66%)  2 1/304 (0.33%)  2 2/308 (0.65%)  7
Vomiting † 1  13/304 (4.28%)  15 11/304 (3.62%)  13 13/304 (4.28%)  14 12/308 (3.90%)  13
General disorders         
Chest discomfort † 1  1/304 (0.33%)  1 0/304 (0.00%)  0 0/304 (0.00%)  0 0/308 (0.00%)  0
Crying † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 1/304 (0.33%)  2 0/308 (0.00%)  0
Discomfort † 1  1/304 (0.33%)  1 0/304 (0.00%)  0 1/304 (0.33%)  1 0/308 (0.00%)  0
Hyperpyrexia † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 1/304 (0.33%)  1 0/308 (0.00%)  0
Influenza like illness † 1  1/304 (0.33%)  1 0/304 (0.00%)  0 0/304 (0.00%)  0 1/308 (0.32%)  1
Injection site bruising † 1  3/304 (0.99%)  3 0/304 (0.00%)  0 1/304 (0.33%)  1 2/308 (0.65%)  2
Injection site erythema † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 0/304 (0.00%)  0 2/308 (0.65%)  2
Injection site induration † 1  1/304 (0.33%)  1 1/304 (0.33%)  1 0/304 (0.00%)  0 0/308 (0.00%)  0
Injection site mass † 1  0/304 (0.00%)  0 1/304 (0.33%)  1 0/304 (0.00%)  0 1/308 (0.32%)  1
Injection site reaction † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 1/304 (0.33%)  1 0/308 (0.00%)  0
Injection site swelling † 1  0/304 (0.00%)  0 1/304 (0.33%)  1 0/304 (0.00%)  0 2/308 (0.65%)  2
Local swelling † 1  1/304 (0.33%)  1 0/304 (0.00%)  0 1/304 (0.33%)  1 0/308 (0.00%)  0
Oedema peripheral † 1  1/304 (0.33%)  1 1/304 (0.33%)  1 0/304 (0.00%)  0 1/308 (0.32%)  1
Pain † 1  72/304 (23.68%)  72 70/304 (23.03%)  70 79/304 (25.99%)  79 68/308 (22.08%)  69
Pyrexia † 1  1/304 (0.33%)  1 1/304 (0.33%)  1 0/304 (0.00%)  0 0/308 (0.00%)  0
Swelling † 1  22/304 (7.24%)  22 26/304 (8.55%)  26 20/304 (6.58%)  20 15/308 (4.87%)  15
Vessel puncture site bruise † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 1/304 (0.33%)  1 0/308 (0.00%)  0
Immune system disorders         
Hypersensitivity † 1  0/304 (0.00%)  0 2/304 (0.66%)  2 1/304 (0.33%)  2 2/308 (0.65%)  2
Milk allergy † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 0/304 (0.00%)  0 1/308 (0.32%)  1
Multiple allergies † 1  0/304 (0.00%)  0 1/304 (0.33%)  1 1/304 (0.33%)  1 0/308 (0.00%)  0
Seasonal allergy † 1  1/304 (0.33%)  1 1/304 (0.33%)  1 1/304 (0.33%)  1 1/308 (0.32%)  1
Infections and infestations         
Abscess † 1  1/304 (0.33%)  1 1/304 (0.33%)  1 0/304 (0.00%)  0 1/308 (0.32%)  1
Acarodermatitis † 1  0/304 (0.00%)  0 1/304 (0.33%)  1 0/304 (0.00%)  0 0/308 (0.00%)  0
Acute sinusitis † 1  0/304 (0.00%)  0 1/304 (0.33%)  1 1/304 (0.33%)  1 0/308 (0.00%)  0
Acute tonsillitis † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 1/304 (0.33%)  1 0/308 (0.00%)  0
Bacteraemia † 1  1/304 (0.33%)  1 0/304 (0.00%)  0 0/304 (0.00%)  0 0/308 (0.00%)  0
Body tinea † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 1/304 (0.33%)  1 0/308 (0.00%)  0
Bronchiolitis † 1  3/304 (0.99%)  3 1/304 (0.33%)  1 2/304 (0.66%)  2 5/308 (1.62%)  5
Bronchitis † 1  2/304 (0.66%)  2 0/304 (0.00%)  0 1/304 (0.33%)  1 3/308 (0.97%)  3
Bronchitis viral † 1  0/304 (0.00%)  0 1/304 (0.33%)  1 0/304 (0.00%)  0 0/308 (0.00%)  0
Candidiasis † 1  1/304 (0.33%)  1 0/304 (0.00%)  0 0/304 (0.00%)  0 2/308 (0.65%)  2
Cellulitis † 1  0/304 (0.00%)  0 2/304 (0.66%)  2 1/304 (0.33%)  1 1/308 (0.32%)  1
Conjunctivitis infective † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 1/304 (0.33%)  1 0/308 (0.00%)  0
Croup infectious † 1  4/304 (1.32%)  5 3/304 (0.99%)  3 6/304 (1.97%)  6 3/308 (0.97%)  3
Ear infection † 1  3/304 (0.99%)  3 1/304 (0.33%)  1 1/304 (0.33%)  1 3/308 (0.97%)  3
Enterovirus infection † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 1/304 (0.33%)  1 0/308 (0.00%)  0
Fungal infection † 1  2/304 (0.66%)  2 2/304 (0.66%)  2 0/304 (0.00%)  0 1/308 (0.32%)  1
Gastroenteritis † 1  2/304 (0.66%)  2 5/304 (1.64%)  5 2/304 (0.66%)  2 5/308 (1.62%)  5
Gastroenteritis viral † 1  0/304 (0.00%)  0 1/304 (0.33%)  1 2/304 (0.66%)  2 0/308 (0.00%)  0
Gingivitis † 1  0/304 (0.00%)  0 1/304 (0.33%)  1 0/304 (0.00%)  0 0/308 (0.00%)  0
Hand-foot-and-mouth disease † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 0/304 (0.00%)  0 1/308 (0.32%)  1
Herpangina † 1  2/304 (0.66%)  2 1/304 (0.33%)  1 1/304 (0.33%)  1 0/308 (0.00%)  0
Hordeolum † 1  1/304 (0.33%)  1 0/304 (0.00%)  0 0/304 (0.00%)  0 0/308 (0.00%)  0
Impetigo † 1  0/304 (0.00%)  0 1/304 (0.33%)  1 0/304 (0.00%)  0 0/308 (0.00%)  0
Infected bites † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 0/304 (0.00%)  0 1/308 (0.32%)  1
Influenza † 1  1/304 (0.33%)  1 3/304 (0.99%)  3 2/304 (0.66%)  2 0/308 (0.00%)  0
Lower respiratory tract infection † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 0/304 (0.00%)  0 1/308 (0.32%)  1
Molluscum contagiosum † 1  0/304 (0.00%)  0 1/304 (0.33%)  1 0/304 (0.00%)  0 1/308 (0.32%)  1
Nasopharyngitis † 1  10/304 (3.29%)  11 8/304 (2.63%)  9 13/304 (4.28%)  14 9/308 (2.92%)  9
Oral candidiasis † 1  3/304 (0.99%)  3 0/304 (0.00%)  0 0/304 (0.00%)  0 0/308 (0.00%)  0
Oral herpes † 1  2/304 (0.66%)  2 0/304 (0.00%)  0 1/304 (0.33%)  1 0/308 (0.00%)  0
Otitis externa † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 1/304 (0.33%)  1 0/308 (0.00%)  0
Otitis media † 1  25/304 (8.22%)  25 25/304 (8.22%)  26 29/304 (9.54%)  31 24/308 (7.79%)  26
Otitis media acute † 1  9/304 (2.96%)  10 10/304 (3.29%)  13 8/304 (2.63%)  8 5/308 (1.62%)  5
Otitis media chronic † 1  0/304 (0.00%)  0 1/304 (0.33%)  1 0/304 (0.00%)  0 1/308 (0.32%)  2
Paronychia † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 1/304 (0.33%)  1 0/308 (0.00%)  0
Pharyngitis † 1  12/304 (3.95%)  12 7/304 (2.30%)  7 10/304 (3.29%)  10 6/308 (1.95%)  6
Pharyngitis streptococcal † 1  1/304 (0.33%)  1 4/304 (1.32%)  4 1/304 (0.33%)  1 3/308 (0.97%)  3
Pneumonia † 1  3/304 (0.99%)  3 0/304 (0.00%)  0 0/304 (0.00%)  0 0/308 (0.00%)  0
Pneumonia bacterial † 1  1/304 (0.33%)  1 0/304 (0.00%)  0 0/304 (0.00%)  0 0/308 (0.00%)  0
Respiratory syncytial virus bronchitis † 1  2/304 (0.66%)  2 1/304 (0.33%)  1 0/304 (0.00%)  0 0/308 (0.00%)  0
Respiratory syncytial virus infection † 1  0/304 (0.00%)  0 1/304 (0.33%)  1 0/304 (0.00%)  0 0/308 (0.00%)  0
Rhinitis † 1  7/304 (2.30%)  7 4/304 (1.32%)  5 6/304 (1.97%)  8 4/308 (1.30%)  4
Sinusitis † 1  3/304 (0.99%)  3 5/304 (1.64%)  5 4/304 (1.32%)  5 3/308 (0.97%)  3
Skin infection † 1  0/304 (0.00%)  0 1/304 (0.33%)  1 0/304 (0.00%)  0 1/308 (0.32%)  1
Staphylococcal infection † 1  0/304 (0.00%)  0 1/304 (0.33%)  1 0/304 (0.00%)  0 1/308 (0.32%)  1
Streptococcal infection † 1  0/304 (0.00%)  0 1/304 (0.33%)  1 0/304 (0.00%)  0 0/308 (0.00%)  0
Subcutaneous abscess † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 0/304 (0.00%)  0 1/308 (0.32%)  1
Tonsillitis † 1  0/304 (0.00%)  0 2/304 (0.66%)  2 1/304 (0.33%)  1 0/308 (0.00%)  0
Upper respiratory tract infection † 1  40/304 (13.16%)  40 22/304 (7.24%)  25 39/304 (12.83%)  40 43/308 (13.96%)  46
Urinary tract infection † 1  0/304 (0.00%)  0 1/304 (0.33%)  1 1/304 (0.33%)  1 1/308 (0.32%)  1
Viral infection † 1  7/304 (2.30%)  7 8/304 (2.63%)  8 9/304 (2.96%)  9 11/308 (3.57%)  11
Viral pharyngitis † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 1/304 (0.33%)  1 0/308 (0.00%)  0
Viral rash † 1  1/304 (0.33%)  1 0/304 (0.00%)  0 0/304 (0.00%)  0 0/308 (0.00%)  0
Viral upper respiratory tract infection † 1  1/304 (0.33%)  1 1/304 (0.33%)  1 0/304 (0.00%)  0 0/308 (0.00%)  0
Vulvovaginitis † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 0/304 (0.00%)  0 1/308 (0.32%)  1
Injury, poisoning and procedural complications         
Accidental exposure to product by child † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 1/304 (0.33%)  1 0/308 (0.00%)  0
Arthropod bite † 1  1/304 (0.33%)  1 2/304 (0.66%)  2 1/304 (0.33%)  1 2/308 (0.65%)  2
Arthropod sting † 1  2/304 (0.66%)  2 0/304 (0.00%)  0 0/304 (0.00%)  0 0/308 (0.00%)  0
Burns second degree † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 1/304 (0.33%)  1 0/308 (0.00%)  0
Concussion † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 0/304 (0.00%)  0 1/308 (0.32%)  1
Contusion † 1  4/304 (1.32%)  4 1/304 (0.33%)  1 0/304 (0.00%)  0 1/308 (0.32%)  1
Corneal abrasion † 1  0/304 (0.00%)  0 1/304 (0.33%)  1 0/304 (0.00%)  0 0/308 (0.00%)  0
Excoriation † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 1/304 (0.33%)  1 0/308 (0.00%)  0
Fall † 1  1/304 (0.33%)  1 0/304 (0.00%)  0 0/304 (0.00%)  0 0/308 (0.00%)  0
Head injury † 1  2/304 (0.66%)  3 2/304 (0.66%)  2 2/304 (0.66%)  5 5/308 (1.62%)  5
Laceration † 1  0/304 (0.00%)  0 1/304 (0.33%)  1 0/304 (0.00%)  0 1/308 (0.32%)  1
Lip injury † 1  1/304 (0.33%)  1 0/304 (0.00%)  0 0/304 (0.00%)  0 0/308 (0.00%)  0
Mouth injury † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 1/304 (0.33%)  1 0/308 (0.00%)  0
Muscle strain † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 0/304 (0.00%)  0 1/308 (0.32%)  1
Thermal burn † 1  1/304 (0.33%)  1 0/304 (0.00%)  0 0/304 (0.00%)  0 1/308 (0.32%)  1
Tongue injury † 1  0/304 (0.00%)  0 1/304 (0.33%)  1 0/304 (0.00%)  0 0/308 (0.00%)  0
Wound † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 0/304 (0.00%)  0 1/308 (0.32%)  1
Investigations         
Bacterial test negative † 1  1/304 (0.33%)  1 0/304 (0.00%)  0 0/304 (0.00%)  0 0/308 (0.00%)  0
Blood iron decreased † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 0/304 (0.00%)  0 1/308 (0.32%)  1
Cardiac murmur † 1  1/304 (0.33%)  1 0/304 (0.00%)  0 0/304 (0.00%)  0 0/308 (0.00%)  0
Metabolism and nutrition disorders         
Decreased appetite † 1  111/304 (36.51%)  112 77/304 (25.33%)  78 110/304 (36.18%)  111 95/308 (30.84%)  96
Dehydration † 1  1/304 (0.33%)  1 0/304 (0.00%)  0 0/304 (0.00%)  0 0/308 (0.00%)  0
Feeding disorder of infancy or early childhood † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 0/304 (0.00%)  0 1/308 (0.32%)  1
Lactose intolerance † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 1/304 (0.33%)  1 1/308 (0.32%)  1
Polydipsia † 1  1/304 (0.33%)  1 0/304 (0.00%)  0 0/304 (0.00%)  0 0/308 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Knee deformity † 1  1/304 (0.33%)  1 0/304 (0.00%)  0 1/304 (0.33%)  1 0/308 (0.00%)  0
Musculoskeletal pain † 1  0/304 (0.00%)  0 1/304 (0.33%)  1 0/304 (0.00%)  0 0/308 (0.00%)  0
Pain in extremity † 1  2/304 (0.66%)  2 0/304 (0.00%)  0 1/304 (0.33%)  1 1/308 (0.32%)  1
Nervous system disorders         
Dizziness † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 0/304 (0.00%)  0 1/308 (0.32%)  1
Drooling † 1  1/304 (0.33%)  1 0/304 (0.00%)  0 0/304 (0.00%)  0 0/308 (0.00%)  0
Lethargy † 1  1/304 (0.33%)  2 1/304 (0.33%)  1 0/304 (0.00%)  0 1/308 (0.32%)  1
Somnolence † 1  133/304 (43.75%)  133 106/304 (34.87%)  106 113/304 (37.17%)  114 109/308 (35.39%)  110
Psychiatric disorders         
Aggression † 1  1/304 (0.33%)  1 0/304 (0.00%)  0 0/304 (0.00%)  0 0/308 (0.00%)  0
Insomnia † 1  2/304 (0.66%)  2 2/304 (0.66%)  3 0/304 (0.00%)  0 0/308 (0.00%)  0
Irritability † 1  181/304 (59.54%)  185 142/304 (46.71%)  142 150/304 (49.34%)  152 153/308 (49.68%)  154
Middle insomnia † 1  1/304 (0.33%)  1 0/304 (0.00%)  0 0/304 (0.00%)  0 0/308 (0.00%)  0
Renal and urinary disorders         
Ketonuria † 1  1/304 (0.33%)  1 0/304 (0.00%)  0 0/304 (0.00%)  0 0/308 (0.00%)  0
Reproductive system and breast disorders         
Genital cyst † 1  0/304 (0.00%)  0 1/304 (0.33%)  1 0/304 (0.00%)  0 0/308 (0.00%)  0
Gynaecomastia † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 1/304 (0.33%)  1 0/308 (0.00%)  0
Penile adhesion † 1  1/304 (0.33%)  1 0/304 (0.00%)  0 0/304 (0.00%)  0 0/308 (0.00%)  0
Vaginal discharge † 1  0/304 (0.00%)  0 1/304 (0.33%)  1 0/304 (0.00%)  0 0/308 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Adenoidal hypertrophy † 1  0/304 (0.00%)  0 1/304 (0.33%)  1 0/304 (0.00%)  0 0/308 (0.00%)  0
Asthma † 1  3/304 (0.99%)  3 0/304 (0.00%)  0 2/304 (0.66%)  2 0/308 (0.00%)  0
Bronchial hyperreactivity † 1  2/304 (0.66%)  2 1/304 (0.33%)  1 3/304 (0.99%)  3 4/308 (1.30%)  4
Cough † 1  25/304 (8.22%)  28 21/304 (6.91%)  24 16/304 (5.26%)  17 19/308 (6.17%)  19
Dyspnoea † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 1/304 (0.33%)  1 0/308 (0.00%)  0
Epistaxis † 1  1/304 (0.33%)  1 1/304 (0.33%)  1 0/304 (0.00%)  0 0/308 (0.00%)  0
Increased upper airway secretion † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 1/304 (0.33%)  1 0/308 (0.00%)  0
Nasal congestion † 1  7/304 (2.30%)  8 13/304 (4.28%)  13 9/304 (2.96%)  9 10/308 (3.25%)  11
Nasal disorder † 1  0/304 (0.00%)  0 0/304 (0.00%)  0 0/304 (0.00%)  0 1/308 (0.32%)  1
Oropharyngeal pain † 1  2/304 (0.66%)  2 0/304 (0.00%)  0 2/304 (0.66%)  2 0/308 (0.00%)  0
Respiratory disorder † 1  1/304 (0.33%)  1 1/304 (0.33%)  1 0/304 (0.00%)  0 0/308 (0.00%)  0
Rhinitis allergic † 1  0/304 (0.00%)  0 1/304 (0.33%)  1 1/304 (0.33%)  1 1/308 (0.32%)  1
Rhinorrhoea † 1  22/304 (7.24%)  27 17/304 (5.59%)  22 21/304 (6.91%)  25 13/308 (4.22%)  13
Stridor † 1  0/304 (0.00%)  0