Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 11 for:    "Rubella" | "Heptavalent Pneumococcal Conjugate Vaccine"

Immunogenicity and Safety of GlaxoSmithKline Biologicals' MMRV Vaccine vs. ProQuad® in Children 12-14 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: NCT00578175
Recruitment Status : Completed
First Posted : December 21, 2007
Results First Posted : August 26, 2010
Last Update Posted : October 8, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Varicella
Rubella
Mumps
Measles
Interventions Biological: Priorix-Tetra™ (MMRV vaccine 208136)
Biological: ProQuad®
Biological: Havrix®
Biological: Prevnar®
Enrollment 1851
Recruitment Details  
Pre-assignment Details While the total numbers of subjects enrolled in the study was of 1851, the total number of subjects that entered the study was 1783. The remaining 67 subjects received a subject number but no vaccine dose and were therefore excluded from the analysis and group assignment.
Arm/Group Title Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group Proquad Group
Hide Arm/Group Description Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh. Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh. Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
Period Title: Overall Study
Started 705 689 389
Completed 635 646 365
Not Completed 70 43 24
Reason Not Completed
Adverse Event             0             1             1
Other reasons             70             42             23
Arm/Group Title Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group Proquad Group Total
Hide Arm/Group Description Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh. Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh. Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly. Total of all reporting groups
Overall Number of Baseline Participants 705 689 389 1783
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 705 participants 689 participants 389 participants 1783 participants
12.3  (0.58) 12.3  (0.59) 12.3  (0.61) 12.3  (0.59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 705 participants 689 participants 389 participants 1783 participants
Female
356
  50.5%
346
  50.2%
186
  47.8%
888
  49.8%
Male
349
  49.5%
343
  49.8%
203
  52.2%
895
  50.2%
1.Primary Outcome
Title Number of Subjects With Seroresponse for Antibodies to Varicella Virus (VZV)
Hide Description Seroresponse for antibodies to VZV is defined as the appearance post-vaccination of anti-VZV antibodies [concentration greater than or equal to the threshold of 75 milli-international units per milliliter (mIU/mL)] in the serum of subjects below the assay cut-off value of 25 mIU/mL before vaccination.
Time Frame At Day 42 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
Arm/Group Title Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group Proquad Group
Hide Arm/Group Description:
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
Overall Number of Participants Analyzed 622 630 347
Measure Type: Number
Unit of Measure: subjects
355 440 301
2.Primary Outcome
Title Concentration of Antibodies to Varicella Virus (VZV)
Hide Description Concentrations are given as Geometric Mean Concentrations (GMCs).
Time Frame At Day 42 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
Arm/Group Title Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group Proquad Group
Hide Arm/Group Description:
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
Overall Number of Participants Analyzed 629 636 352
Geometric Mean (95% Confidence Interval)
Unit of Measure: milli-international units per milliliter
83.6
(77.0 to 90.8)
109.9
(102.1 to 118.3)
164.3
(152.3 to 177.3)
3.Primary Outcome
Title Number of Subjects With Seroresponse for Antibodies to Mumps Virus
Hide Description Seroresponse for antibodies to mumps virus is defined as the appearance post-vaccination of anti-mumps virus antibodies [titer greater than or equal to the threshold of 51 Effective Doses (ED50)] in the serum of subjects below the assay cut-off value of 24 ED50 before vaccination.
Time Frame At Day 42 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
Arm/Group Title Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group Proquad Group
Hide Arm/Group Description:
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
Overall Number of Participants Analyzed 532 531 276
Measure Type: Number
Unit of Measure: subjects
491 498 256
4.Primary Outcome
Title Number of Subjects With Seroresponse for Antibodies to Measles Virus
Hide Description Seroresponse for antibodies to measles virus is defined as the appearance post-vaccination of anti-measles virus antibodies [concentration greater than or equal to the threshold of 200 milli-international units per milliliter (mIU/mL)] in the serum of subjects below the assay cut-off value of 150 mIU/mL before vaccination.
Time Frame At Day 42 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
Arm/Group Title Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group Proquad Group
Hide Arm/Group Description:
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh. .
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
Overall Number of Participants Analyzed 626 636 350
Measure Type: Number
Unit of Measure: subjects
616 633 342
5.Primary Outcome
Title Number of Subjects With Seroresponse for Antibodies to Rubella Virus
Hide Description Seroresponse for antibodies to rubella virus is defined as the appearance post-vaccination of anti-rubella virus antibodies [concentration greater than or equal to the threshold of 10 international units per milliliter (IU/mL)] in the serum of subjects below the assay cut-off value of 4 IU/mL before vaccination.
Time Frame At Day 42 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
Arm/Group Title Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group Proquad Group
Hide Arm/Group Description:
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
Overall Number of Participants Analyzed 628 636 351
Measure Type: Number
Unit of Measure: subjects
616 622 349
6.Primary Outcome
Title Concentration of Antibodies to Hepatitis A Virus (HAV)
Hide Description Concentrations are given as Geometric Mean Concentrations (GMCs).
Time Frame At Day 42 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
Arm/Group Title Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group Proquad Group
Hide Arm/Group Description:
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
Overall Number of Participants Analyzed 404 409 227
Geometric Mean (95% Confidence Interval)
Unit of Measure: milli-international units per milliliter
40.5
(37.1 to 44.2)
40.3
(37.0 to 44.0)
40.0
(35.7 to 44.9)
7.Primary Outcome
Title Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F
Hide Description Concentrations are given as Geometric Mean Concentrations (GMCs).
Time Frame At Day 42 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
Arm/Group Title Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group Proquad Group
Hide Arm/Group Description:
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
Overall Number of Participants Analyzed 461 468 266
Geometric Mean (95% Confidence Interval)
Unit of Measure: micrograms per milliliter (µg/mL)
S.Pneu.4 (n= 461, 463, 266)
3.35
(3.10 to 3.63)
3.31
(3.04 to 3.59)
3.02
(2.72 to 3.34)
S.Pneu.6B (n= 460, 464, 265)
5.65
(5.16 to 6.19)
5.91
(5.40 to 6.45)
5.43
(4.90 to 6.02)
S.Pneu.9V (n=461, 468, 266)
5.81
(5.37 to 6.29)
5.66
(5.23 to 6.13)
5.54
(5.02 to 6.12)
S.Pneu.14 (n= 460, 465, 266)
9.71
(8.99 to 10.50)
9.54
(8.81 to 10.34)
8.96
(8.07 to 9.95)
S.Pneu.18C (n= 458, 465, 263)
5.50
(5.04 to 6.01)
5.80
(5.30 to 6.34)
5.51
(4.95 to 6.12)
S.Pneu.19F (n= 454, 460, 261)
2.52
(2.32 to 2.74)
2.52
(2.32 to 2.73)
2.31
(2.06 to 2.59)
S.Pneu.23F (n= 459, 464, 266)
10.10
(9.22 to 11.06)
10.85
(9.87 to 11.91)
9.79
(8.65 to 11.07)
8.Secondary Outcome
Title Antibody Titers to Mumps Virus
Hide Description Data are expressed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum.
Time Frame At Day 42 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
Arm/Group Title Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
Hide Arm/Group Description:
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
Overall Number of Participants Analyzed 591 601 327
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
222.4
(202.5 to 244.3)
224.6
(206.9 to 243.9)
253.1
(222.7 to 287.7)
9.Secondary Outcome
Title Concentration of Antibodies to Measles Virus
Hide Description Concentrations are given as Geometric Mean Concentrations (GMCs).
Time Frame At Day 42 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
Arm/Group Title Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
Hide Arm/Group Description:
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
Overall Number of Participants Analyzed 626 636 350
Geometric Mean (95% Confidence Interval)
Unit of Measure: milli-international units per milliliter
4723.1
(4436.4 to 5028.4)
4650.3
(4430.9 to 4880.5)
4207.1
(3823.3 to 4629.3)
10.Secondary Outcome
Title Concentration of Antibodies to Rubella Virus
Hide Description Concentrations are given as Geometric Mean Concentrations (GMCs).
Time Frame At Day 42 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
Arm/Group Title Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
Hide Arm/Group Description:
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
Overall Number of Participants Analyzed 629 636 352
Geometric Mean (95% Confidence Interval)
Unit of Measure: International units per milliliter
59.9
(55.9 to 64.1)
57.9
(54.4 to 61.7)
71.4
(65.5 to 77.8)
11.Secondary Outcome
Title Number of Subjects With Vaccine Response to Havrix
Hide Description Vaccine response to Havrix is defined as the appearance post-vaccination of anti-hepatitis A virus (anti-HAV) antibodies [concentration greater than or equal to 15 milli-international units per milliliter (mIU/mL)] in the serum of subjects seronegative before vaccination (concentration below the assay cut-off value of 15 mIU/mL) or having a 2-fold increase above the pre-vaccination concentration in subjects who were seropositive before vaccination.
Time Frame At Day 42 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
Arm/Group Title Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
Hide Arm/Group Description:
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
Overall Number of Participants Analyzed 404 409 227
Measure Type: Number
Unit of Measure: subjects
344 345 195
12.Secondary Outcome
Title Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value
Hide Description Cut-off value assessed include 0.05 micrograms per milliliter (µg/mL).
Time Frame At Day 42 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
Arm/Group Title Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
Hide Arm/Group Description:
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
Overall Number of Participants Analyzed 461 468 266
Measure Type: Number
Unit of Measure: subjects
Anti-S.Pneu-4 (n= 461, 463, 266) 461 463 266
Anti-S.Pneu-6B (n= 460, 464, 265) 459 463 265
Anti-S.Pneu-9V (n= 461, 468, 266) 461 468 266
Anti-S.Pneu-14 (n= 460, 465, 266) 460 465 266
Anti-S.Pneu-18C (n= 458, 465, 263) 458 465 263
Anti-S.Pneu-19F (n= 454, 460, 261) 454 460 261
Anti-S.Pneu-23F (n= 459, 464, 266) 459 464 266
13.Secondary Outcome
Title Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value
Hide Description Cut-off value assessed include 0.2 micrograms per milliliter (µg/mL).
Time Frame At Day 42 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
Arm/Group Title Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
Hide Arm/Group Description:
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
Overall Number of Participants Analyzed 461 468 266
Measure Type: Number
Unit of Measure: subjects
Anti-S.Pneu-4 (n= 461, 463, 266) 461 463 266
Anti-S.Pneu-6B (n= 460, 464, 265) 458 460 265
Anti-S.Pneu-9V (n= 461, 468, 266) 461 468 266
Anti-S.Pneu-14 (n= 460, 465, 266) 460 465 266
Anti-S.Pneu-18C (n= 458, 465, 263) 458 464 263
Anti-S.Pneu-19F (n= 454, 460, 261) 451 459 259
Anti-S.Pneu-23F (n= 459, 464, 266) 459 464 266
14.Secondary Outcome
Title Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value
Hide Description Cut-off value assessed include 0.5 micrograms per milliliter (µg/mL).
Time Frame At Day 42 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
Arm/Group Title Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
Hide Arm/Group Description:
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
Overall Number of Participants Analyzed 461 468 266
Measure Type: Number
Unit of Measure: subjects
Anti-S.Pneu-4 (n= 461, 463, 266) 456 459 265
Anti-S.Pneu-6B (n= 460, 464, 265) 453 459 264
Anti-S.Pneu-9V (n= 461, 468, 266) 459 466 266
Anti-S.Pneu-14 (n= 460, 465, 266) 459 464 266
Anti-S.Pneu-18C (n= 458, 465, 263) 458 463 263
Anti-S.Pneu-19F (n= 454, 460, 261) 431 448 249
Anti-S.Pneu-23F (n= 459, 464, 266) 458 462 266
15.Secondary Outcome
Title Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value
Hide Description Cut-off value assessed include 1.0 micrograms per milliliter (µg/mL).
Time Frame At Day 42 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
Arm/Group Title Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
Hide Arm/Group Description:
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
Overall Number of Participants Analyzed 461 468 266
Measure Type: Number
Unit of Measure: subjects
Anti-S.Pneu-4 (n= 461, 463, 266) 437 423 249
Anti-S.Pneu-6B (n= 460, 464, 265) 442 453 259
Anti-S.Pneu-9V (n= 461, 468, 266) 450 459 265
Anti-S.Pneu-14 (n= 460, 465, 266) 458 463 266
Anti-S.Pneu-18C (n= 458, 465, 263) 446 455 259
Anti-S.Pneu-19F (n= 454, 460, 261) 390 390 214
Anti-S.Pneu-23F (n= 459, 464, 266) 446 458 265
16.Secondary Outcome
Title Number of Subjects Reporting Solicited Local Symptoms
Hide Description Solicited local symptoms assessed include pain, redness and swelling.
Time Frame During the 4 day follow up period following vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.
Arm/Group Title Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
Hide Arm/Group Description:
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
Overall Number of Participants Analyzed 673 666 378
Measure Type: Number
Unit of Measure: subjects
Pain 136 114 65
Redness 111 120 54
Swelling 50 49 21
17.Secondary Outcome
Title Number of Subjects Reporting Fever ≥ 38.0°C/100.4°F and > 39.5°C/103.1°F During the 15-day Follow up Period After Vaccination
Hide Description Fever was measured rectally.
Time Frame During the 15-day follow-up period following vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.
Arm/Group Title Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
Hide Arm/Group Description:
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
Overall Number of Participants Analyzed 676 668 379
Measure Type: Number
Unit of Measure: subjects
≥ 38.0°C/100.4°F 248 241 120
> 39.5°C/103.1°F 33 48 14
18.Secondary Outcome
Title Number of Subjects Reporting Fever ≥ 38.0°C/100.4°F and > 39.5°C/103.1°F During the 43-day Follow-up Period After Vaccination
Hide Description Fever was measured rectally.
Time Frame During the 43-day follow-up period following vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.
Arm/Group Title Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
Hide Arm/Group Description:
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
Overall Number of Participants Analyzed 676 668 379
Measure Type: Number
Unit of Measure: subjects
≥ 38.0°C/100.4°F 312 301 162
> 39.5°C/103.1°F 52 71 24
19.Secondary Outcome
Title Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash
Hide Description [Not Specified]
Time Frame During the 43-day follow-up period after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.
Arm/Group Title Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
Hide Arm/Group Description:
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
Overall Number of Participants Analyzed 676 668 379
Measure Type: Number
Unit of Measure: subjects
37 25 15
20.Secondary Outcome
Title Number of Subjects Reporting Investigator-confirmed Varicella-like Rash
Hide Description [Not Specified]
Time Frame During the 43-day follow-up period after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.
Arm/Group Title Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
Hide Arm/Group Description:
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
Overall Number of Participants Analyzed 676 668 379
Measure Type: Number
Unit of Measure: subjects
10 9 6
21.Secondary Outcome
Title Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling
Hide Description [Not Specified]
Time Frame During the 43-day follow-up period after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.
Arm/Group Title Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
Hide Arm/Group Description:
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
Overall Number of Participants Analyzed 676 668 379
Measure Type: Number
Unit of Measure: subjects
14 7 5
22.Secondary Outcome
Title Number of Subjects Reporting Unsolicited Adverse Events and Medically-attended Adverse Events (Excluding Rash and Parotid/Salivary Gland Swelling)
Hide Description

Unsolicited adverse event covers any adverse event 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.

Medically-attended adverse event covers any adverse event which received medical attention. Medical attention is defined as hospitalization, an emergency room visit or a visit to or from medical personnel.

Time Frame During the 43-day follow-up period after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort.
Arm/Group Title Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
Hide Arm/Group Description:
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
Overall Number of Participants Analyzed 705 689 389
Measure Type: Number
Unit of Measure: subjects
Unsolicited adverse events 338 332 191
Medically-attended adverse events 217 213 124
23.Secondary Outcome
Title Number of Subjects Reporting New Onset Chronic Illnesses and Conditions Prompting Emergency Room Visits
Hide Description New onset chronic illnesses include autoimmune disorders, asthma, type I diabetes and allergies.
Time Frame For approximately 6 months (Day 0-180)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort.
Arm/Group Title Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
Hide Arm/Group Description:
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
Overall Number of Participants Analyzed 705 689 389
Measure Type: Number
Unit of Measure: subjects
New onsets of chronic diseases 11 11 7
Emergency room visits 63 63 44
24.Secondary Outcome
Title Number of Subjects Reporting Serious Adverse Events
Hide Description Serious adverse events assessed include medical occurrences that result in death, is 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 For approximately 6 months (Day 0-180)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort.
Arm/Group Title Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
Hide Arm/Group Description:
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
Overall Number of Participants Analyzed 705 689 389
Measure Type: Number
Unit of Measure: subjects
14 20 7
Time Frame Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Adverse Event Reporting Description

Events collected by systematic assessment are reported for subjects with a symptom diary card available.

Events collected by non-systematic method are reported for the Total Vaccinated Cohort.

 
Arm/Group Title Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group Proquad Group
Hide Arm/Group Description Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh. Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh. Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
All-Cause Mortality
Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group Proquad Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/705 (0.00%)   0/689 (0.00%)   0/389 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group Proquad Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/705 (1.99%)   20/689 (2.90%)   7/389 (1.80%) 
Gastrointestinal disorders       
Dysphagia * 1  1/705 (0.14%)  0/689 (0.00%)  0/389 (0.00%) 
Gastrooesophageal reflux disease * 1  1/705 (0.14%)  0/689 (0.00%)  0/389 (0.00%) 
Vomiting * 1  0/705 (0.00%)  1/689 (0.15%)  0/389 (0.00%) 
General disorders       
Pyrexia * 1  0/705 (0.00%)  1/689 (0.15%)  0/389 (0.00%) 
Infections and infestations       
Gastroenteritis * 1  1/705 (0.14%)  2/689 (0.29%)  0/389 (0.00%) 
Cellulitis * 1  2/705 (0.28%)  0/689 (0.00%)  0/389 (0.00%) 
Groin abscess * 1  0/705 (0.00%)  2/689 (0.29%)  0/389 (0.00%) 
Pneumonia * 1  0/705 (0.00%)  0/689 (0.00%)  2/389 (0.51%) 
Staphylococcal infection * 1  1/705 (0.14%)  1/689 (0.15%)  0/389 (0.00%) 
Abscess * 1  0/705 (0.00%)  1/689 (0.15%)  0/389 (0.00%) 
Acute sinusitis * 1  0/705 (0.00%)  0/689 (0.00%)  1/389 (0.26%) 
Bronchiolitis * 1  0/705 (0.00%)  0/689 (0.00%)  1/389 (0.26%) 
Croup infectious * 1  0/705 (0.00%)  1/689 (0.15%)  0/389 (0.00%) 
Ear infection * 1  1/705 (0.14%)  0/689 (0.00%)  0/389 (0.00%) 
Gastroenteritis rotavirus * 1  0/705 (0.00%)  0/689 (0.00%)  1/389 (0.26%) 
Otitis media * 1  1/705 (0.14%)  0/689 (0.00%)  0/389 (0.00%) 
Periorbital cellulitis * 1  0/705 (0.00%)  0/689 (0.00%)  1/389 (0.26%) 
Perirectal abscess * 1  0/705 (0.00%)  0/689 (0.00%)  1/389 (0.26%) 
Pneumonia viral * 1  0/705 (0.00%)  1/689 (0.15%)  0/389 (0.00%) 
Respiratory syncytial virus bronchiolitis * 1  1/705 (0.14%)  0/689 (0.00%)  0/389 (0.00%) 
Respiratory syncytial virus infection * 1  1/705 (0.14%)  0/689 (0.00%)  0/389 (0.00%) 
Subcutaneous abscess * 1  1/705 (0.14%)  0/689 (0.00%)  0/389 (0.00%) 
Upper respiratory tract infection * 1  0/705 (0.00%)  1/689 (0.15%)  0/389 (0.00%) 
Viral infection * 1  0/705 (0.00%)  1/689 (0.15%)  0/389 (0.00%) 
Injury, poisoning and procedural complications       
Accidental drug intake by child * 1  1/705 (0.14%)  0/689 (0.00%)  0/389 (0.00%) 
Accidental exposure * 1  1/705 (0.14%)  0/689 (0.00%)  0/389 (0.00%) 
Burns second degree * 1  0/705 (0.00%)  1/689 (0.15%)  0/389 (0.00%) 
Foreign body trauma * 1  0/705 (0.00%)  0/689 (0.00%)  1/389 (0.26%) 
Thermal burn * 1  0/705 (0.00%)  1/689 (0.15%)  0/389 (0.00%) 
Metabolism and nutrition disorders       
Dehydration * 1  0/705 (0.00%)  1/689 (0.15%)  0/389 (0.00%) 
Hpoglycaemia * 1  0/705 (0.00%)  1/689 (0.15%)  0/389 (0.00%) 
Type 1 diabetes mellitus * 1  0/705 (0.00%)  1/689 (0.15%)  0/389 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Primitive neuroectodermal tumour * 1  0/705 (0.00%)  1/689 (0.15%)  0/389 (0.00%) 
Nervous system disorders       
Febrile convulsion * 1  0/705 (0.00%)  2/689 (0.29%)  0/389 (0.00%) 
Convulsion * 1  1/705 (0.14%)  0/689 (0.00%)  0/389 (0.00%) 
Partial seizures * 1  0/705 (0.00%)  1/689 (0.15%)  0/389 (0.00%) 
Psychiatric disorders       
Autism spectrum disorder * 1  0/705 (0.00%)  1/689 (0.15%)  0/389 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Asthma * 1  1/705 (0.14%)  1/689 (0.15%)  0/389 (0.00%) 
Bronchial hyperreactivity * 1  0/705 (0.00%)  2/689 (0.29%)  0/389 (0.00%) 
Aspiration * 1  0/705 (0.00%)  1/689 (0.15%)  0/389 (0.00%) 
Atelectasis * 1  1/705 (0.14%)  0/689 (0.00%)  0/389 (0.00%) 
Hypoxia * 1  0/705 (0.00%)  1/689 (0.15%)  0/389 (0.00%) 
Respiratory distress * 1  0/705 (0.00%)  1/689 (0.15%)  0/389 (0.00%) 
1
Term from vocabulary, MedDRA (unspecified)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group Proquad Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   547/705 (77.59%)   541/689 (78.52%)   297/389 (76.35%) 
Gastrointestinal disorders       
Teething * 2  42/705 (5.96%)  53/689 (7.69%)  28/389 (7.20%) 
Diarrhoea * 2  37/705 (5.25%)  46/689 (6.68%)  29/389 (7.46%) 
General disorders       
Pain  1  136/673 (20.21%)  114/666 (17.12%)  65/378 (17.20%) 
Redness  1  111/673 (16.49%)  120/666 (18.02%)  54/378 (14.29%) 
Swelling  1  50/673 (7.43%)  49/666 (7.36%)  21/378 (5.56%) 
Fever  1  312/676 (46.15%)  302/668 (45.21%)  163/379 (43.01%) 
Rash  1  221/676 (32.69%)  219/668 (32.78%)  128/379 (33.77%) 
Irritability * 2  25/705 (3.55%)  35/689 (5.08%)  20/389 (5.14%) 
Infections and infestations       
Otitis media * 2  71/705 (10.07%)  62/689 (9.00%)  34/389 (8.74%) 
Uper respiratory tract infection * 2  49/705 (6.95%)  58/689 (8.42%)  42/389 (10.80%) 
Respiratory, thoracic and mediastinal disorders       
Rhinorrhoea * 2  29/705 (4.11%)  21/689 (3.05%)  24/389 (6.17%) 
1
Term from vocabulary, MedDRA 12.0
2
Term from vocabulary, MedDRA (Unspecified)
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00578175     History of Changes
Other Study ID Numbers: 110058
First Submitted: December 20, 2007
First Posted: December 21, 2007
Results First Submitted: March 5, 2010
Results First Posted: August 26, 2010
Last Update Posted: October 8, 2018