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Trial record 33 of 141 for:    "Measles"

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Subjects Four to Six Years of Age

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ClinicalTrials.gov Identifier: NCT01621802
Recruitment Status : Completed
First Posted : June 18, 2012
Results First Posted : September 13, 2017
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Rubella
Mumps
Measles
Interventions Biological: Priorix
Biological: M-M-R II
Biological: Kinrix
Biological: ProQuad
Enrollment 4011

Recruitment Details Subjects were enrolled in 3 sub-cohorts. Sub-cohort 1: Inv_MMR_CO and Com_MMR_CO (Lot 1 or Lot 2), Sub-cohort 2: Inv_MMR_I and Com_MMR_I (Lot 1 or Lot 2) and Sub-cohort 3: Inv_MMR_S and Com_MMR_S (Lot 1 or Lot 2).
Pre-assignment Details 4011 subjects were enrolled in the study with 4007 eligible subjects receiving a study vaccination.
Arm/Group Title Inv_MMR_CO Group Com_MMR_CO Group Inv_MMR_I Group Com_MMR_I Group Inv_MMR_S Group Com_MMR_S Group
Hide Arm/Group Description Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0). Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0). Subjects received one dose of Priorix at Visit 1 (Day 0). Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0). Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0). Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Period Title: Overall Study
Started 802 298 796 303 1319 489
Completed 755 275 763 292 1284 477
Not Completed 47 23 33 11 35 12
Reason Not Completed
Protocol Violation             0             0             0             0             0             1
Withdrawal by Subject             8             4             4             2             2             0
Migrated/moved from study area             0             0             2             0             1             0
Others             3             3             3             2             1             0
Lost to Follow-up             36             16             24             7             31             11
Arm/Group Title Inv_MMR_CO Group Com_MMR_CO Group Inv_MMR_I Group Com_MMR_I Group Inv_MMR_S Group Com_MMR_S Group Total
Hide Arm/Group Description Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0). Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0). Subjects received one dose of Priorix at Visit 1 (Day 0). Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0). Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0). Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0). Total of all reporting groups
Overall Number of Baseline Participants 802 298 796 303 1319 489 4007
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 802 participants 298 participants 796 participants 303 participants 1319 participants 489 participants 4007 participants
4.1  (0.3) 4.1  (0.3) 4.4  (0.6) 4.3  (0.6) 4.4  (0.6) 4.4  (0.6) 4.3  (0.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 802 participants 298 participants 796 participants 303 participants 1319 participants 489 participants 4007 participants
Female
398
  49.6%
134
  45.0%
361
  45.4%
153
  50.5%
632
  47.9%
225
  46.0%
1903
  47.5%
Male
404
  50.4%
164
  55.0%
435
  54.6%
150
  49.5%
687
  52.1%
264
  54.0%
2104
  52.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race/Ethnicity Number Analyzed 802 participants 298 participants 796 participants 303 participants 1319 participants 489 participants 4007 participants
African Heritage / African American
96
  12.0%
39
  13.1%
48
   6.0%
19
   6.3%
94
   7.1%
32
   6.5%
328
   8.2%
American Indian or Alaskan Native
130
  16.2%
38
  12.8%
15
   1.9%
3
   1.0%
4
   0.3%
0
   0.0%
190
   4.7%
Asian - Central/South Asian Heritage
12
   1.5%
5
   1.7%
7
   0.9%
1
   0.3%
8
   0.6%
0
   0.0%
33
   0.8%
Asian - East Asian Heritage
28
   3.5%
6
   2.0%
384
  48.2%
146
  48.2%
565
  42.8%
209
  42.7%
1338
  33.4%
Asian - Japanese Heritage
3
   0.4%
0
   0.0%
0
   0.0%
1
   0.3%
1
   0.1%
0
   0.0%
5
   0.1%
Asian - South East Asian Heritage
49
   6.1%
25
   8.4%
11
   1.4%
4
   1.3%
16
   1.2%
8
   1.6%
113
   2.8%
Native Hawaiian or Other Pacific Islander
4
   0.5%
2
   0.7%
2
   0.3%
0
   0.0%
3
   0.2%
0
   0.0%
11
   0.3%
Other
112
  14.0%
45
  15.1%
35
   4.4%
9
   3.0%
52
   3.9%
22
   4.5%
275
   6.9%
White - Arabic / North African Heritage
5
   0.6%
3
   1.0%
3
   0.4%
3
   1.0%
1
   0.1%
0
   0.0%
15
   0.4%
White - Caucasian / European Heritage
363
  45.3%
135
  45.3%
291
  36.6%
117
  38.6%
575
  43.6%
218
  44.6%
1699
  42.4%
1.Primary Outcome
Title Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value
Hide Description Seroresponse was defined as post-vaccination anti-measles virus antibody concentration equal to or above (≥) 200 milli-international Units per milliliter (mIU/mL). Analysis was done in sub-cohorts 1 and 2 only.
Time Frame 42 days post vaccination (At Day 42)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on According to Protocol (ATP) cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for measles vaccine component, did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.
Arm/Group Title Inv_MMR_CO Group Com_MMR_CO Group Inv_MMR_I Group Com_MMR_I Group
Hide Arm/Group Description:
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of Priorix at Visit 1 (Day 0).
Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Overall Number of Participants Analyzed 697 249 736 283
Measure Type: Count of Participants
Unit of Measure: Participants
697
 100.0%
249
 100.0%
736
 100.0%
281
  99.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inv_MMR_CO Group, Com_MMR_CO Group
Comments

Power obtained using PASS 2005 (Likelihood Score [Miettienen and Nurminen approach]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value & alpha=1.25%.

The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 1 should be at least 94.04% (=100%- the sum of type II errors associated to cohort 1.

Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority criterion for sub cohort 1: Lower limit (LL) of the 2-sided 97.5% confidence interval (CI) for group difference (Inv_MMR_CO Group minus pooled Com_MMR_CO Group) in seroresponse rates to measles, mumps and rubella viruses is ≥ -5%.
Method of Estimation Estimation Parameter Difference in seroresponse rate (%)
Estimated Value 0.00
Confidence Interval (2-Sided) 97.5%
-0.72 to 1.98
Estimation Comments Difference in percentage (Inv_MMR_CO Group minus Com_MMR_CO Group) in percentage of subjects with an anti-measles antibody concentration ≥ 200 mIU/mL.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Inv_MMR_I Group, Com_MMR_I Group
Comments

Power obtained using PASS 2005 (Likelihood Score [Miettienen and Nurminen approach]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value & alpha=1.25%.

The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 2 should be at least 98.88% (=100%- the sum of type II error associated to cohort 2.

Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for group difference (Inv_MMR_I group minus pooled Com_MMR_I group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.
Method of Estimation Estimation Parameter Difference in Seroresponse rate (%)
Estimated Value 0.71
Confidence Interval (2-Sided) 97.5%
0.02 to 2.97
Estimation Comments Difference in percentage (Inv_MMR_I Group minus Com_MMR_I Group) in percentage of subjects with an anti-Measles antibody concentration ≥ 200 mIU/mL.
2.Primary Outcome
Title Number of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value
Hide Description Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 ELISA Units per milliliter (EU/mL). Analysis was done in sub-cohorts 1 and 2 only.
Time Frame 42 days post vaccination (At Day 42)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for mumps vaccine component, did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.
Arm/Group Title Inv_MMR_CO Group Com_MMR_CO Group Inv_MMR_I Group Com_MMR_I Group
Hide Arm/Group Description:
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of Priorix at Visit 1 (Day 0).
Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Overall Number of Participants Analyzed 698 250 736 283
Measure Type: Count of Participants
Unit of Measure: Participants
698
 100.0%
250
 100.0%
736
 100.0%
283
 100.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inv_MMR_CO Group, Com_MMR_CO Group
Comments

Power obtained using PASS 2005 (Likelihood Score [Miettienen and Nurminen approach]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value & alpha=1.25%.

The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 1 should be at least 94.04% (=100%- the sum of type II errors associated to cohort 1.

Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority criterion for sub cohort 1: The LL of the 2-sided 97.5% CI for group difference (Inv_MMR_CO Group minus pooled Com_MMR_CO Group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.
Method of Estimation Estimation Parameter Difference in seroresponse rate (%)
Estimated Value 0.00
Confidence Interval (2-Sided) 97.5%
-0.72 to 1.97
Estimation Comments Difference in percentage (Inv_MMR_CO Group minus Com_MMR_CO Group) in percentage of subjects with an anti-mumps antibody concentration ≥ 10 EU/mL.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Inv_MMR_I Group, Com_MMR_I Group
Comments

Power obtained using PASS 2005 (Likelihood Score [Miettienen and Nurminen approach]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value & alpha=1.25%.

The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 2 should be at least 98.88% (=100%- the sum of type II error associated to cohort 2.

Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for group difference (Inv_MMR_I group minus pooled Com_MMR_I group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.
Method of Estimation Estimation Parameter Difference in Seroresponse rate (%)
Estimated Value 0.00
Confidence Interval (2-Sided) 97.5%
-0.68 to 1.75
Estimation Comments Difference in percentage (Inv_MMR_I Group minus Com_MMR_I Group) in percentage of subjects with an anti-mumps antibody concentration ≥ 10 EU/mL.
3.Primary Outcome
Title Number of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value
Hide Description Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 International Units per milliliter (IU/mL). Analysis was done in sub-cohorts 1 and 2 only.
Time Frame 42 days post vaccination (At Day 42)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for rubella vaccine component, did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.
Arm/Group Title Inv_MMR_CO Group Com_MMR_CO Group Inv_MMR_I Group Com_MMR_I Group
Hide Arm/Group Description:
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of Priorix at Visit 1 (Day 0).
Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Overall Number of Participants Analyzed 697 249 736 283
Measure Type: Count of Participants
Unit of Measure: Participants
696
  99.9%
249
 100.0%
736
 100.0%
283
 100.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inv_MMR_CO Group, Com_MMR_CO Group
Comments

Power obtained using PASS 2005 (Likelihood Score [Miettienen and Nurminen approach]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value & alpha=1.25%.

The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 1 should be at least 94.04% (=100%- the sum of type II errors associated to cohort 1.

Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority criterion for sub cohort 1: The LL of the 2-sided 97.5% CI for group difference (Inv_MMR_CO group minus pooled Com_MMR_CO group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.
Method of Estimation Estimation Parameter Difference in seroresponse rate (%)
Estimated Value -0.14
Confidence Interval (2-Sided) 97.5%
-0.98 to 1.84
Estimation Comments Difference in percentage (Inv_MMR_CO Group minus Com_MMR_CO Group) in percentage of subjects with an anti-rubella antibody concentration ≥ 10 IU/mL.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Inv_MMR_I Group, Com_MMR_I Group
Comments

Power obtained using PASS 2005 (Likelihood Score [Miettienen and Nurminen approach]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value & alpha=1.25%.

The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 2 should be at least 98.88% (=100%- the sum of type II error associated to cohort 2.

Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for group difference (Inv_MMR_I group minus pooled Com_MMR_I group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.
Method of Estimation Estimation Parameter Difference in seroresponse rate (%)
Estimated Value 0.00
Confidence Interval (2-Sided) 97.5%
-0.68 to 1.75
Estimation Comments Difference in percentage (Inv_MMR_I Group minus Com_MMR_I Group) in percentage of subjects with an anti-rubella antibody concentration ≥ 10 IU/mL.
4.Primary Outcome
Title Evaluation of Immunogenicity in Terms of Anti-measles Virus Antibody Concentrations
Hide Description Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. Analysis was done in sub-cohorts 1 and 2 only.
Time Frame 42 days after vaccination (At Day 42)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for measles vaccine component, did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.
Arm/Group Title Inv_MMR_CO Group Com_MMR_CO Group Inv_MMR_I Group Com_MMR_I Group
Hide Arm/Group Description:
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of Priorix at Visit 1 (Day 0).
Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Overall Number of Participants Analyzed 697 249 736 283
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
4335.0
(4089.7 to 4594.9)
4215.6
(3806.7 to 4668.4)
3646.6
(3453.5 to 3850.4)
3503.9
(3174.6 to 3867.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inv_MMR_CO Group, Com_MMR_CO Group
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority criterion for sub cohort 1: The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv_MMR_CO group divided by pooled Com_MMR_CO group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments Ancova model: adjustment for baseline concentration - pooled variance
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 0.99
Confidence Interval (2-Sided) 97.5%
0.92 to 1.06
Estimation Comments The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Inv_MMR_I Group, Com_MMR_I Group
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv_MMR_I group divided by pooled Com_MMR_I group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments Ancova model: adjustment for baseline concentration country - pooled variance
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 1.03
Confidence Interval (2-Sided) 97.5%
0.96 to 1.10
Estimation Comments The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.
5.Primary Outcome
Title Evaluation of Immunogenicity in Terms of Anti-mumps Virus Antibody Concentrations
Hide Description Antibody concentrations were expressed as GMCs in EU/mL. Analysis was done in sub-cohorts 1 and 2 only.
Time Frame 42 days post vaccination (At Day 42)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for mumps vaccine component, did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.
Arm/Group Title Inv_MMR_CO Group Com_MMR_CO Group Inv_MMR_I Group Com_MMR_I Group
Hide Arm/Group Description:
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of Priorix at Visit 1 (Day 0).
Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Overall Number of Participants Analyzed 698 250 736 283
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
170.5
(161.6 to 179.9)
190.1
(174.7 to 206.8)
167.2
(158.6 to 176.3)
176.2
(161.5 to 192.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inv_MMR_CO Group, Com_MMR_CO Group
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv_MMR_CO group divided by pooled Com_MMR_CO group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments Ancova model: adjustment for baseline concentration - pooled variance
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 0.91
Confidence Interval (2-Sided) 97.5%
0.83 to 1.00
Estimation Comments The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Inv_MMR_I Group, Com_MMR_I Group
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv_MMR_I group divided by pooled Com_MMR_I group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments Ancova model: adjustment for baseline concentration - pooled variance.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 0.96
Confidence Interval (2-Sided) 97.5%
0.87 to 1.06
Estimation Comments The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.
6.Primary Outcome
Title Evaluation of Immunogenicity in Terms of Anti-rubella Virus Antibody Concentrations
Hide Description Antibody concentrations were expressed as GMCs in IU/mL. Analysis was done in sub-cohorts 1 and 2 only.
Time Frame 42 days post vaccination (At Day 42)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for rubella vaccine component, did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.
Arm/Group Title Inv_MMR_CO Group Com_MMR_CO Group Inv_MMR_I Group Com_MMR_I Group
Hide Arm/Group Description:
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of Priorix at Visit 1 (Day 0).
Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Overall Number of Participants Analyzed 697 249 736 283
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
96.4
(92.6 to 100.4)
96.0
(89.5 to 103.0)
98.9
(95.3 to 102.8)
98.7
(93.2 to 104.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inv_MMR_CO Group, Com_MMR_CO Group
Comments Adjusted geometric mean concentration (GMC) ratio (Inv_MMR_CO group divided by Com_MMR_CO group) for antibodies to rubella virus.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority criterion for sub cohort 1: The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv_MMR_CO group divided by pooled Com_MMR_CO group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments Ancova model: adjustment for baseline concentration - pooled variance.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 1.03
Confidence Interval (2-Sided) 97.5%
0.97 to 1.09
Estimation Comments The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Inv_MMR_I Group, Com_MMR_I Group
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv_MMR_I group divided by pooled Com_MMR_I group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments Ancova model: adjustment for baseline concentration - pooled variance.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 1.01
Confidence Interval (2-Sided) 97.5%
0.95 to 1.07
Estimation Comments The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.
7.Secondary Outcome
Title Number of Subjects With Anti-varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off-value
Hide Description Seroresponse was defined as post-vaccination anti-VZV antibody concentration ≥ 75 mIU/mL. Analysis was done in sub-cohort 1 only.
Time Frame 42 days post vaccination (At Day 42)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.
Arm/Group Title Inv_MMR_CO Group Com_MMR_CO Group
Hide Arm/Group Description:
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Overall Number of Participants Analyzed 695 247
Measure Type: Count of Participants
Unit of Measure: Participants
693
  99.7%
247
 100.0%
8.Secondary Outcome
Title Evaluation of Immunogenicity in Terms of Anti-VZV Antibody Concentrations
Hide Description Antibody concentrations were expressed as GMCs in mIU/mL. Analysis was done in sub-cohort 1 only.
Time Frame 42 days post vaccination (At Day 42)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.
Arm/Group Title Inv_MMR_CO Group Com_MMR_CO Group
Hide Arm/Group Description:
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Overall Number of Participants Analyzed 695 247
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
887.7
(834.3 to 944.4)
820.4
(749.3 to 898.3)
9.Secondary Outcome
Title Number of Subjects With Antibody Booster Response to Diphtheria Toxin (Anti-D) and Tetanus Toxin (Anti-T)
Hide Description

Booster response was defined as:

For subjects with pre-vaccination antibody concentration less than (<) 0.1 IU/mL, antibody concentration ≥ 0.4 IU/ml at Day 42.

For subjects with pre-vaccination antibody concentration ≥ 0.1 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.

Analysis was done in sub-cohort 1 only.

Time Frame 42 days post vaccination (At Day 42)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.
Arm/Group Title Inv_MMR_CO Group Com_MMR_CO Group
Hide Arm/Group Description:
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Overall Number of Participants Analyzed 661 234
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-D Number Analyzed 659 participants 233 participants
657
  99.7%
233
 100.0%
Anti-T Number Analyzed 661 participants 234 participants
621
  93.9%
224
  95.7%
10.Secondary Outcome
Title Number of Subjects With Antibody Booster Response to Pertussis Toxin (PT)
Hide Description

Booster response was defined as:

For initially seronegative subjects, antibody concentration ≥ 10.772 IU/mL at Day 42.

For initially seropositive subjects with pre-vaccination antibody concentration < 10.772 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.

For initially seropositive subjects with pre-vaccination antibody concentration ≥ 10.772 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration.

Analysis was done in sub-cohort 1 only.

Time Frame 42 days post vaccination (At Day 42)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.
Arm/Group Title Inv_MMR_CO Group Com_MMR_CO Group
Hide Arm/Group Description:
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Overall Number of Participants Analyzed 659 233
Measure Type: Count of Participants
Unit of Measure: Participants
643
  97.6%
225
  96.6%
11.Secondary Outcome
Title Number of Subjects With Antibody Booster Response to Filamentous Hemagglutinin (FHA)
Hide Description

Booster response was defined as:

For initially seronegative subjects, antibody concentration ≥ 8.184 IU/ml at Day 42.

For initially seropositive subjects with pre-vaccination antibody concentration < 8.184 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.

For initially seropositive subjects with pre-vaccination antibody concentration ≥ 8.184 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration.

Analysis was done in sub-cohort 1 only.

Time Frame 42 days post vaccination (At Day 42)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.
Arm/Group Title Inv_MMR_CO Group Com_MMR_CO Group
Hide Arm/Group Description:
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Overall Number of Participants Analyzed 659 234
Measure Type: Count of Participants
Unit of Measure: Participants
620
  94.1%
221
  94.4%
12.Secondary Outcome
Title Number of Subjects With Antibody Booster Response to Pertactin (PRN)
Hide Description

Booster response was defined as:

For initially seronegative subjects, antibody concentration ≥ 8.748 IU/mL at Day 42.

For initially seropositive subjects with pre-vaccination antibody concentration < 8.748 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.

For initially seropositive subjects with pre-vaccination antibody concentration ≥ 8.748 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration.

Analysis was done in sub-cohort 1 only.

Time Frame 42 days post vaccination (At Day 42)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.
Arm/Group Title Inv_MMR_CO Group Com_MMR_CO Group
Hide Arm/Group Description:
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Overall Number of Participants Analyzed 660 234
Measure Type: Count of Participants
Unit of Measure: Participants
657
  99.5%
233
  99.6%
13.Secondary Outcome
Title Evaluation of Immunogenicity in Terms of Anti-D and Anti-T Antibody Concentrations
Hide Description Antibody concentrations were expressed as GMCs in IU/mL. Analysis was done in sub-cohort 1 only.
Time Frame 42 days post vaccination (At Day 42)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.
Arm/Group Title Inv_MMR_CO Group Com_MMR_CO Group
Hide Arm/Group Description:
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Overall Number of Participants Analyzed 684 243
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
Anti-D
17.2
(16.2 to 18.1)
17.8
(16.1 to 19.6)
Anti-T
7.4
(6.9 to 7.8)
8.4
(7.6 to 9.3)
14.Secondary Outcome
Title Evaluation of Immunogenicity in Terms of Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Hide Description Antibody concentrations were expressed as GMCs in EU/mL. Analysis was done in sub-cohort 1 only.
Time Frame 42 days post vaccination (At Day 42)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.
Arm/Group Title Inv_MMR_CO Group Com_MMR_CO Group
Hide Arm/Group Description:
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Overall Number of Participants Analyzed 684 243
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
Anti-PT Number Analyzed 684 participants 243 participants
76.6
(71.6 to 82.0)
73.9
(66.2 to 82.4)
Anti-FHA Number Analyzed 684 participants 243 participants
316.2
(299.4 to 334.0)
319.3
(293.1 to 347.9)
Anti-PRN Number Analyzed 682 participants 243 participants
402.2
(370.4 to 436.8)
427.3
(377.6 to 483.4)
15.Secondary Outcome
Title Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL
Hide Description Analysis was done in sub-cohort 1 only.
Time Frame 42 days post vaccination (At Day 42)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.
Arm/Group Title Inv_MMR_CO Group Com_MMR_CO Group
Hide Arm/Group Description:
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Overall Number of Participants Analyzed 684 243
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-D
684
 100.0%
243
 100.0%
Anti-T
684
 100.0%
243
 100.0%
16.Secondary Outcome
Title Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 1.0 IU/mL
Hide Description Analysis was done in sub-cohort 1 only.
Time Frame 42 days post vaccination (At Day 42)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.
Arm/Group Title Inv_MMR_CO Group Com_MMR_CO Group
Hide Arm/Group Description:
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Overall Number of Participants Analyzed 684 243
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-D
683
  99.9%
242
  99.6%
Anti-T
678
  99.1%
243
 100.0%
17.Secondary Outcome
Title Evaluation of Immunogenicity in Terms of Anti-polio Virus Types 1, 2 and 3 Antibody Titers
Hide Description Antibody titers were expressed as Geometric Mean Titers (GMTs) in ED50. Analysis was done in sub-cohort 1 only.
Time Frame 42 days post vaccination (At Day 42)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.
Arm/Group Title Inv_MMR_CO Group Com_MMR_CO Group
Hide Arm/Group Description:
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Overall Number of Participants Analyzed 669 238
Geometric Mean (95% Confidence Interval)
Unit of Measure: ED50
Anti-Polio 1 Number Analyzed 669 participants 238 participants
1618.7
(1499.8 to 1747.0)
1587.3
(1387.3 to 1816.1)
Anti-Polio 2 Number Analyzed 653 participants 233 participants
2026.4
(1881.2 to 2182.7)
2206.1
(1955.2 to 2489.3)
Anti-Polio 3 Number Analyzed 590 participants 214 participants
2753.5
(2512.4 to 3017.6)
3040.6
(2613.0 to 3538.1)
18.Secondary Outcome
Title Number of Subjects With Solicited Local Symptoms
Hide Description Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling = greater than 50 millimeters (m m ) i.e . > 50mm.
Time Frame During the 4-day (Days 0-3) post-vaccination period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. Analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e., symptom screen/sheet completed).
Arm/Group Title Inv_MMR_CO Group Com_MMR_CO Group Inv_MMR_I Group Com_MMR_I Group Inv_MMR_S Group Com_MMR_S Group
Hide Arm/Group Description:
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of Priorix at Visit 1 (Day 0).
Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Overall Number of Participants Analyzed 727 267 766 289 1289 480
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain
295
  40.6%
109
  40.8%
152
  19.8%
64
  22.1%
278
  21.6%
123
  25.6%
Grade 3 Pain
22
   3.0%
4
   1.5%
6
   0.8%
2
   0.7%
5
   0.4%
2
   0.4%
Any Redness
157
  21.6%
69
  25.8%
146
  19.1%
53
  18.3%
242
  18.8%
90
  18.8%
Grade 3 Redness
9
   1.2%
4
   1.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any Swelling
82
  11.3%
28
  10.5%
64
   8.4%
23
   8.0%
108
   8.4%
42
   8.8%
Grade 3 Swelling
3
   0.4%
3
   1.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
19.Secondary Outcome
Title Number of Subjects With Solicited General Symptoms
Hide Description

Assessed solicited general symptoms were drowsiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Drowsiness = Drowsiness that prevented normal activity, Grade 3 Loss of appetite = Not eating at all. Related = symptom assessed by the investigator as causally related to study vaccination.

Analysis was done for sub-cohort 1 only.

Time Frame During the 4-day (Days 0-3) post-vaccination period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. Analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e., symptom screen/sheet completed).
Arm/Group Title Inv_MMR_CO Group Com_MMR_CO Group
Hide Arm/Group Description:
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Overall Number of Participants Analyzed 731 268
Measure Type: Count of Participants
Unit of Measure: Participants
Any Drowsiness
199
  27.2%
72
  26.9%
Grade 3 Drowsiness
10
   1.4%
3
   1.1%
Related Drowsiness
180
  24.6%
63
  23.5%
Any Loss of appetite
154
  21.1%
59
  22.0%
Grade 3 Loss of appetite
2
   0.3%
2
   0.7%
Related Loss of appetite
135
  18.5%
56
  20.9%
20.Secondary Outcome
Title Number of Subjects Reporting Fever
Hide Description Any fever = fever ≥ 38°C; Grade 3 fever = fever > 39.5°C; Related = fever assessed by the investigator as causally related to study vaccination.
Time Frame During the 43-day (Days 0-42) post-vaccination period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. Analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e., symptom screen/sheet completed).
Arm/Group Title Inv_MMR_CO Group Com_MMR_CO Group Inv_MMR_I Group Com_MMR_I Group Inv_MMR_S Group Com_MMR_S Group
Hide Arm/Group Description:
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of Priorix at Visit 1 (Day 0).
Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Overall Number of Participants Analyzed 731 268 767 291 1291 481
Measure Type: Count of Participants
Unit of Measure: Participants
Any fever
177
  24.2%
67
  25.0%
146
  19.0%
58
  19.9%
257
  19.9%
96
  20.0%
Grade 3 fever
7
   1.0%
6
   2.2%
14
   1.8%
9
   3.1%
21
   1.6%
8
   1.7%
Related fever
100
  13.7%
32
  11.9%
27
   3.5%
11
   3.8%
52
   4.0%
25
   5.2%
21.Secondary Outcome
Title Number of Subjects Reporting MMR Specific Solicited General Symptoms
Hide Description Assessed MMR specific symptoms were parotid gland swelling and any suspected signs of meningism including febrile convulsions. Any = occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination. Grade 3 Parotid/salivary gland swelling = Swelling accompanied with general symptoms. Grade 3 Sign of meningism (any suspected signs including febrile convulsions) = An event which prevented normal, everyday activities. Related = symptom assessed by the investigator as causally related to study vaccination.
Time Frame During the 43-day (Days 0-42) post-vaccination period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. Analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e., symptom screen/sheet completed).
Arm/Group Title Inv_MMR_CO Group Com_MMR_CO Group Inv_MMR_I Group Com_MMR_I Group Inv_MMR_S Group Com_MMR_S Group
Hide Arm/Group Description:
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of Priorix at Visit 1 (Day 0).
Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Overall Number of Participants Analyzed 731 268 767 291 1291 481
Measure Type: Count of Participants
Unit of Measure: Participants
Any Sign of meningism
0
   0.0%
2
   0.7%
1
   0.1%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 Sign of meningism
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Related Sign of meningism
0
   0.0%
2
   0.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any Parotid gland swelling
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.3%
1
   0.1%
1
   0.2%
Grade 3 Parotid gland swelling
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Related Parotid gland swelling
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.3%
1
   0.1%
1
   0.2%
22.Secondary Outcome
Title Number of Subjects Reporting Investigator-confirmed Rash
Hide Description Assessed any rash, varicella-like rash, measles/rubella-like rash, Grade 3, related. Any= occurrence of rash regardless of intensity grade. Grade 3 measles/rubella/varicella-like rash = Rash with more than 150 lesions. Other Grade 3 Rash = Rash that prevented normal, everyday activities. Related= Rash assessed by the investigator as causally related to study vaccination.
Time Frame During the 43-day (Days 0-42) post-vaccination period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. Analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e., symptom screen/sheet completed).
Arm/Group Title Inv_MMR_CO Group Com_MMR_CO Group Inv_MMR_I Group Com_MMR_I Group Inv_MMR_S Group Com_MMR_S Group
Hide Arm/Group Description:
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of Priorix at Visit 1 (Day 0).
Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Overall Number of Participants Analyzed 731 268 767 291 1291 481
Measure Type: Count of Participants
Unit of Measure: Participants
Any localized or generalized
61
   8.3%
28
  10.4%
37
   4.8%
12
   4.1%
56
   4.3%
23
   4.8%
Any with fever
11
   1.5%
7
   2.6%
5
   0.7%
1
   0.3%
6
   0.5%
1
   0.2%
Any Varicella like
4
   0.5%
3
   1.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any Measles/Rubella like
14
   1.9%
5
   1.9%
3
   0.4%
2
   0.7%
4
   0.3%
2
   0.4%
Any grade 3
3
   0.4%
0
   0.0%
1
   0.1%
0
   0.0%
3
   0.2%
0
   0.0%
Any related
25
   3.4%
11
   4.1%
2
   0.3%
2
   0.7%
8
   0.6%
3
   0.6%
Localized any
50
   6.8%
24
   9.0%
27
   3.5%
9
   3.1%
42
   3.3%
19
   4.0%
Localized administration site
9
   1.2%
2
   0.7%
1
   0.1%
0
   0.0%
8
   0.6%
0
   0.0%
Localized other site
41
   5.6%
22
   8.2%
26
   3.4%
9
   3.1%
36
   2.8%
19
   4.0%
Localized with fever
8
   1.1%
6
   2.2%
4
   0.5%
0
   0.0%
4
   0.3%
1
   0.2%
Localized Varicella like
2
   0.3%
2
   0.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Localized Measles/Rubella like
12
   1.6%
4
   1.5%
3
   0.4%
2
   0.7%
4
   0.3%
1
   0.2%
Localized Grade 3
2
   0.3%
0
   0.0%
1
   0.1%
0
   0.0%
0
   0.0%
0
   0.0%
Localized related
18
   2.5%
10
   3.7%
2
   0.3%
2
   0.7%
7
   0.5%
2
   0.4%
Generalized any
12
   1.6%
4
   1.5%
10
   1.3%
3
   1.0%
15
   1.2%
4
   0.8%
Generalized with fever
3
   0.4%
1
   0.4%
1
   0.1%
1
   0.3%
2
   0.2%
0
   0.0%
Generalized Varicella like
2
   0.3%
1
   0.4%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Generalized Measles/Rubella like
2
   0.3%
1
   0.4%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.2%
Generalized Grade 3
1
   0.1%
0
   0.0%
0
   0.0%
0
   0.0%
3
   0.2%
0
   0.0%
Generalized Related
7
   1.0%
1
   0.4%
0
   0.0%
0
   0.0%
1
   0.1%
1
   0.2%
23.Secondary Outcome
Title Number of Subjects With New Onset Chronic Diseases (NOCDs)
Hide Description NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
Time Frame During the entire study period (from Day 0 up to Day 180)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Inv_MMR_CO Group Com_MMR_CO Group Inv_MMR_I Group Com_MMR_I Group Inv_MMR_S Group Com_MMR_S Group
Hide Arm/Group Description:
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of Priorix at Visit 1 (Day 0).
Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Overall Number of Participants Analyzed 802 298 796 303 1319 489
Measure Type: Count of Participants
Unit of Measure: Participants
8
   1.0%
4
   1.3%
6
   0.8%
0
   0.0%
11
   0.8%
3
   0.6%
24.Secondary Outcome
Title Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
Hide Description The number of subjects reporting adverse events resulting in Emergency Room (ER) visits is reported.
Time Frame During the entire study period (from Day 0 up to Day 180)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Inv_MMR_CO Group Com_MMR_CO Group Inv_MMR_I Group Com_MMR_I Group Inv_MMR_S Group Com_MMR_S Group
Hide Arm/Group Description:
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of Priorix at Visit 1 (Day 0).
Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Overall Number of Participants Analyzed 802 298 796 303 1319 489
Measure Type: Count of Participants
Unit of Measure: Participants
61
   7.6%
29
   9.7%
64
   8.0%
22
   7.3%
102
   7.7%
36
   7.4%
25.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 was defined as 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Inv_MMR_CO Group Com_MMR_CO Group Inv_MMR_I Group Com_MMR_I Group Inv_MMR_S Group Com_MMR_S Group
Hide Arm/Group Description:
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of Priorix at Visit 1 (Day 0).
Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Overall Number of Participants Analyzed 802 298 796 303 1319 489
Measure Type: Count of Participants
Unit of Measure: Participants
276
  34.4%
90
  30.2%
314
  39.4%
112
  37.0%
508
  38.5%
186
  38.0%
26.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination.
Time Frame During the entire study period (from Day 0 up to Day 180)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Inv_MMR_CO Group Com_MMR_CO Group Inv_MMR_I Group Com_MMR_I Group Inv_MMR_S Group Com_MMR_S Group
Hide Arm/Group Description:
Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of the licensed vaccine M-M-RII (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Subjects received one dose of Priorix at Visit 1 (Day 0).
Subjects received one dose of M-M-RII (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
Subjects in this safety cohort received one dose of M-M-RII (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Overall Number of Participants Analyzed 802 298 796 303 1319 489
Measure Type: Count of Participants
Unit of Measure: Participants
4
   0.5%
0
   0.0%
14
   1.8%
1
   0.3%
25
   1.9%
9
   1.8%
Time Frame Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Inv_MMR_CO Group Com_MMR_CO Group Inv_MMR_I Group Com_MMR_I Group Inv_MMR_S Group Com_MMR_S Group
Hide Arm/Group Description Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0). Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0). Subjects received one dose of Priorix at Visit 1 (Day 0). Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0). Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0). Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
All-Cause Mortality
Inv_MMR_CO Group Com_MMR_CO Group Inv_MMR_I Group Com_MMR_I Group Inv_MMR_S Group Com_MMR_S Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/802 (0.00%)      0/298 (0.00%)      0/796 (0.00%)      0/303 (0.00%)      0/1319 (0.00%)      0/489 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Inv_MMR_CO Group Com_MMR_CO Group Inv_MMR_I Group Com_MMR_I Group Inv_MMR_S Group Com_MMR_S Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/802 (0.50%)      0/298 (0.00%)      14/796 (1.76%)      1/303 (0.33%)      25/1319 (1.90%)      9/489 (1.84%)    
Blood and lymphatic system disorders             
Thrombocytopenia  1  0/802 (0.00%)  0 0/298 (0.00%)  0 0/796 (0.00%)  0 0/303 (0.00%)  0 0/1319 (0.00%)  0 1/489 (0.20%)  1
Gastrointestinal disorders             
Abdominal discomfort  1  1/802 (0.12%)  1 0/298 (0.00%)  0 0/796 (0.00%)  0 0/303 (0.00%)  0 0/1319 (0.00%)  0 0/489 (0.00%)  0
Abdominal pain  1  0/802 (0.00%)  0 0/298 (0.00%)  0 0/796 (0.00%)  0 0/303 (0.00%)  0 1/1319 (0.08%)  1 0/489 (0.00%)  0
Cyclic vomiting syndrome  1  0/802 (0.00%)  0 0/298 (0.00%)  0 0/796 (0.00%)  0 0/303 (0.00%)  0 1/1319 (0.08%)  1 0/489 (0.00%)  0
Gastritis  1  0/802 (0.00%)  0 0/298 (0.00%)  0 1/796 (0.13%)  1 0/303 (0.00%)  0 2/1319 (0.15%)  4 0/489 (0.00%)  0
Ileus  1  0/802 (0.00%)  0 0/298 (0.00%)  0 0/796 (0.00%)  0 0/303 (0.00%)  0 1/1319 (0.08%)  1 0/489 (0.00%)  0
Inguinal hernia  1  0/802 (0.00%)  0 0/298 (0.00%)  0 0/796 (0.00%)  0 0/303 (0.00%)  0 0/1319 (0.00%)  0 1/489 (0.20%)  1
Vomiting  1  0/802 (0.00%)  0 0/298 (0.00%)  0 0/796 (0.00%)  0 0/303 (0.00%)  0 1/1319 (0.08%)  1 0/489 (0.00%)  0
Hepatobiliary disorders             
Hepatic function abnormal  1  0/802 (0.00%)  0 0/298 (0.00%)  0 0/796 (0.00%)  0 0/303 (0.00%)  0 1/1319 (0.08%)  1 0/489 (0.00%)  0
Infections and infestations             
Adenovirus infection  1  0/802 (0.00%)  0 0/298 (0.00%)  0 0/796 (0.00%)  0 0/303 (0.00%)  0 0/1319 (0.00%)  0 1/489 (0.20%)  1
Appendicitis perforated  1  1/802 (0.12%)  1 0/298 (0.00%)  0 0/796 (0.00%)  0 0/303 (0.00%)  0 0/1319 (0.00%)  0 0/489 (0.00%)  0
Bronchitis  1  0/802 (0.00%)  0 0/298 (0.00%)  0 0/796 (0.00%)  0 0/303 (0.00%)  0 0/1319 (0.00%)  0 1/489 (0.20%)  1
Cellulitis  1  0/802 (0.00%)  0 0/298 (0.00%)  0 0/796 (0.00%)  0 0/303 (0.00%)  0 1/1319 (0.08%)  1 0/489 (0.00%)  0
Gastroenteritis  1  0/802 (0.00%)  0 0/298 (0.00%)  0 2/796 (0.25%)  3 0/303 (0.00%)  0 5/1319 (0.38%)  5 1/489 (0.20%)  1
Gastroenteritis rotavirus  1  0/802 (0.00%)  0 0/298 (0.00%)  0 0/796 (0.00%)  0 0/303 (0.00%)  0 1/1319 (0.08%)  1 0/489 (0.00%)  0
Herpangina  1  0/802 (0.00%)  0 0/298 (0.00%)  0 1/796 (0.13%)  1 0/303 (0.00%)  0 0/1319 (0.00%)  0 0/489 (0.00%)  0
Influenza  1  0/802 (0.00%)  0 0/298 (0.00%)  0 0/796 (0.00%)  0 0/303 (0.00%)  0 1/1319 (0.08%)  1 3/489 (0.61%)  3
Otitis media  1  0/802 (0.00%)  0 0/298 (0.00%)  0 0/796 (0.00%)  0 0/303 (0.00%)  0 2/1319 (0.15%)  2 0/489 (0.00%)  0
Otitis media acute  1  0/802 (0.00%)  0 0/298 (0.00%)  0 0/796 (0.00%)  0 0/303 (0.00%)  0 2/1319 (0.15%)  2 0/489 (0.00%)  0
Pneumonia  1  0/802 (0.00%)  0 0/298 (0.00%)  0 2/796 (0.25%)  2 1/303 (0.33%)  1 0/1319 (0.00%)  0 3/489 (0.61%)  3
Pneumonia bacterial  1  0/802 (0.00%)  0 0/298 (0.00%)  0 0/796 (0.00%)  0 0/303 (0.00%)  0 1/1319 (0.08%)  1 0/489 (0.00%)  0
Pyelonephritis  1  0/802 (0.00%)  0 0/298 (0.00%)  0 0/796 (0.00%)  0 0/303 (0.00%)  0 1/1319 (0.08%)  1 0/489 (0.00%)  0
Tonsillitis  1  0/802 (0.00%)  0 0/298 (0.00%)  0 0/796 (0.00%)  0 0/303 (0.00%)  0 2/1319 (0.15%)  2 1/489 (0.20%)  1
Upper respiratory tract infection  1  0/802 (0.00%)  0 0/298 (0.00%)  0 0/796 (0.00%)  0 0/303 (0.00%)  0 2/1319 (0.15%)  2 0/489 (0.00%)  0
Viral infection  1  0/802 (0.00%)  0 0/298 (0.00%)  0 1/796 (0.13%)  1 0/303 (0.00%)  0 0/1319 (0.00%)  0 0/489 (0.00%)  0
Viral upper respiratory tract infection  1  0/802 (0.00%)  0 0/298 (0.00%)  0 1/796 (0.13%)  1 0/303 (0.00%)  0 0/1319 (0.00%)  0 0/489 (0.00%)  0
Injury, poisoning and procedural complications             
Accidental exposure to product  1  0/802 (0.00%)  0 0/298 (0.00%)  0 1/796 (0.13%)  1 0/303 (0.00%)  0 0/1319 (0.00%)  0 0/489 (0.00%)  0
Concussion  1  0/802 (0.00%)  0 0/298 (0.00%)  0 0/796 (0.00%)  0 0/303 (0.00%)  0 0/1319 (0.00%)  0 1/489 (0.20%)  1
Injury  1  0/802 (0.00%)  0 0/298 (0.00%)  0 0/796 (0.00%)  0 0/303 (0.00%)  0 1/1319 (0.08%)  1 0/489 (0.00%)  0
Road traffic accident  1  0/802 (0.00%)  0 0/298 (0.00%)  0 1/796 (0.13%)  1 0/303 (0.00%)  0 0/1319 (0.00%)  0 0/489 (0.00%)  0
Metabolism and nutrition disorders             
Dehydration  1  0/802 (0.00%)  0 0/298 (0.00%)  0 1/796 (0.13%)  1 0/303 (0.00%)  0 2/1319 (0.15%)  2 0/489 (0.00%)  0
Hypovolaemia  1  0/802 (0.00%)  0 0/298 (0.00%)  0 1/796 (0.13%)  1 0/303 (0.00%)  0 1/1319 (0.08%)  1 0/489 (0.00%)  0
Nervous system disorders             
Febrile convulsion  1  0/802 (0.00%)  0 0/298 (0.00%)  0 1/796 (0.13%)  1 0/303 (0.00%)  0 0/1319 (0.00%)  0 0/489 (0.00%)  0
Renal and urinary disorders             
Dysuria  1  0/802 (0.00%)  0 0/298 (0.00%)  0 1/796 (0.13%)  1 0/303 (0.00%)  0 0/1319 (0.00%)  0 0/489 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Adenoidal hypertrophy  1  0/802 (0.00%)  0 0/298 (0.00%)  0 1/796 (0.13%)  1 0/303 (0.00%)  0 2/1319 (0.15%)  2 0/489 (0.00%)  0
Asthma  1  2/802 (0.25%)  2 0/298 (0.00%)  0 4/796 (0.50%)  4 0/303 (0.00%)  0 0/1319 (0.00%)  0 2/489 (0.41%)  3
Bronchial hyperreactivity  1  1/802 (0.12%)  1 0/298 (0.00%)  0 0/796 (0.00%)  0 0/303 (0.00%)  0 0/1319 (0.00%)  0 0/489 (0.00%)  0
Sleep apnoea syndrome  1  0/802 (0.00%)  0 0/298 (0.00%)  0 0/796 (0.00%)  0 0/303 (0.00%)  0 1/1319 (0.08%)  1 0/489 (0.00%)  0
Status asthmaticus  1  0/802 (0.00%)  0 0/298 (0.00%)  0 0/796 (0.00%)  0 0/303 (0.00%)  0 1/1319 (0.08%)  1 0/489 (0.00%)  0
Tonsillar hypertrophy  1  0/802 (0.00%)  0 0/298 (0.00%)  0 1/796 (0.13%)  1 0/303 (0.00%)  0 0/1319 (0.00%)  0 0/489 (0.00%)  0
Skin and subcutaneous tissue disorders             
Eczema vesicular  1  0/802 (0.00%)  0 0/298 (0.00%)  0 0/796 (0.00%)  0 0/303 (0.00%)  0 1/1319 (0.08%)  1 0/489 (0.00%)  0
Rash generalised  1  0/802 (0.00%)  0 0/298 (0.00%)  0 0/796 (0.00%)  0 0/303 (0.00%)  0 1/1319 (0.08%)  1 0/489 (0.00%)  0
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Inv_MMR_CO Group Com_MMR_CO Group Inv_MMR_I Group Com_MMR_I Group Inv_MMR_S Group Com_MMR_S Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   544/802 (67.83%)      198/298 (66.44%)      410/796 (51.51%)      156/303 (51.49%)      702/1319 (53.22%)      279/489 (57.06%)    
General disorders             
Injection site erythema  1  170/802 (21.20%)  173 73/298 (24.50%)  75 147/796 (18.47%)  147 53/303 (17.49%)  53 242/1319 (18.35%)  242 90/489 (18.40%)  90
Injection site pain  1  309/802 (38.53%)  321 118/298 (39.60%)  125 153/796 (19.22%)  153 64/303 (21.12%)  64 278/1319 (21.08%)  278 123/489 (25.15%)  123
Injection site swelling  1  97/802 (12.09%)  97 31/298 (10.40%)  32 64/796 (8.04%)  64 23/303 (7.59%)  23 108/1319 (8.19%)  108 42/489 (8.59%)  42
Pyrexia  1  177/802 (22.07%)  177 67/298 (22.48%)  67 146/796 (18.34%)  146 58/303 (19.14%)  58 257/1319 (19.48%)  257 96/489 (19.63%)  96
Infections and infestations             
Nasopharyngitis  1  25/802 (3.12%)  27 3/298 (1.01%)  3 77/796 (9.67%)  100 28/303 (9.24%)  32 112/1319 (8.49%)  143 45/489 (9.20%)  57
Upper respiratory tract infection  1  27/802 (3.37%)  28 11/298 (3.69%)  11 55/796 (6.91%)  66 27/303 (8.91%)  35 92/1319 (6.97%)  107 21/489 (4.29%)  22
Metabolism and nutrition disorders             
Decreased appetite  1  156/802 (19.45%)  159 61/298 (20.47%)  61 2/796 (0.25%)  2 1/303 (0.33%)  1 3/1319 (0.23%)  3 0/489 (0.00%)  0
Nervous system disorders             
Somnolence  1  199/802 (24.81%)  199 73/298 (24.50%)  73 1/796 (0.13%)  1 0/303 (0.00%)  0 0/1319 (0.00%)  0 0/489 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Cough  1  38/802 (4.74%)  41 16/298 (5.37%)  17 37/796 (4.65%)  41 8/303 (2.64%)  8 47/1319 (3.56%)  50 21/489 (4.29%)  22
Skin and subcutaneous tissue disorders             
Rash  1  61/802 (7.61%)  61 28/298 (9.40%)  28 37/796 (4.65%)  37 12/303 (3.96%)  12 56/1319 (4.25%)  56 23/489 (4.70%)  23
1
Term from vocabulary, MedDRA 20.0
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: NCT01621802     History of Changes
Other Study ID Numbers: 115158
2011-004638-32 ( EudraCT Number )
First Submitted: June 14, 2012
First Posted: June 18, 2012
Results First Submitted: October 18, 2016
Results First Posted: September 13, 2017
Last Update Posted: September 13, 2017