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Trial record 8 of 11 for:    "Rubella" | "Heptavalent Pneumococcal Conjugate Vaccine"

Consistency Study of GlaxoSmithKline (GSK) Biologicals' MMR Vaccine (209762) (Priorix) Comparing Immunogenicity and Safety to Merck & Co., Inc.'s MMR Vaccine (M-M-R II), in Children 12 to 15 Months of Age

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ClinicalTrials.gov Identifier: NCT01702428
Recruitment Status : Completed
First Posted : October 8, 2012
Results First Posted : June 28, 2018
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Rubella
Measles
Mumps
Interventions Biological: Priorix
Biological: M-M-R II
Biological: Varivax
Biological: Havrix
Biological: Prevnar 13
Enrollment 5016
Recruitment Details 13 subjects from 5016 were allocated subject number but no study vaccine was administered. Therefore, the number of subjects started is 5003.
Pre-assignment Details Sub-cohorts for this study were as follows: • US sub-cohort: Subjects recruited in US and received INV_MMR or COM_MMR co-administered with Varivax (VV), Havrix (HAV) and Prevnar (PCV-13) vaccines at Visit 1 (Day 0). • Non-US sub-cohort: Subjects recruited outside US and received INV_MMR or COM_MMR co-administered with VV and HAV vaccines at Day 0.
Arm/Group Title INV_MMR_L1 Group INV_MMR_L2 Group INV_MMR_L3 Group COM_MMR Group
Hide Arm/Group Description Subjects received 1 dose of GSK's candidate combined measles, mumps and rubella (MMR) investigational vaccine (INV_MMR) Lot 1 (L1) co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Subjects received 1 dose of GSK's candidate combined measles, mumps and rubella (MMR) investigational vaccine (INV_MMR) Lot 2 (L2) co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Subjects received 1 dose of GSK's candidate combined measles, mumps and rubella (MMR) investigational vaccine (INV_MMR) Lot 3 (L3) co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.
Period Title: Overall Study
Started 1239 1232 1243 1289
Completed 1175 1162 1190 1232
Not Completed 64 70 53 57
Reason Not Completed
Adverse Event             2             0             0             0
Lost to Follow-up             33             41             37             44
Parents cannot assist to site             1             0             1             0
Lost Coverage             0             0             0             1
Lost Health Plan             3             5             0             2
Mother transferred care             0             1             0             0
Parents too busy             1             0             0             0
Protocol Violation             3             0             1             0
Withdrawal by Subject             21             23             14             10
Arm/Group Title INV_MMR_L1 Group INV_MMR_L2 Group INV_MMR_L3 Group COM_MMR Group Total
Hide Arm/Group Description Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group. Total of all reporting groups
Overall Number of Baseline Participants 1239 1232 1243 1289 5003
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 1239 participants 1232 participants 1243 participants 1289 participants 5003 participants
12.3  (0.7) 12.3  (0.7) 12.3  (0.7) 12.3  (0.7) 12.3  (0.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1239 participants 1232 participants 1243 participants 1289 participants 5003 participants
Female
607
  49.0%
594
  48.2%
615
  49.5%
618
  47.9%
2434
  48.7%
Male
632
  51.0%
638
  51.8%
628
  50.5%
671
  52.1%
2569
  51.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1239 participants 1232 participants 1243 participants 1289 participants 5003 participants
White - Arabic / North African Heritage
5
   0.4%
6
   0.5%
2
   0.2%
7
   0.5%
20
   0.4%
Asian - Central/South Asian Heritage
14
   1.1%
6
   0.5%
7
   0.6%
9
   0.7%
36
   0.7%
Other
170
  13.7%
155
  12.6%
162
  13.0%
163
  12.6%
650
  13.0%
Native Hawaiian or Other Pacific Islander
3
   0.2%
1
   0.1%
5
   0.4%
2
   0.2%
11
   0.2%
American Indian or Alaskan Native
25
   2.0%
37
   3.0%
33
   2.7%
31
   2.4%
126
   2.5%
White - Caucasian / European Heritage
932
  75.2%
938
  76.1%
944
  75.9%
970
  75.3%
3784
  75.6%
Asian - South East Asian Heritage
21
   1.7%
25
   2.0%
21
   1.7%
26
   2.0%
93
   1.9%
African Heritage / African American
60
   4.8%
52
   4.2%
57
   4.6%
70
   5.4%
239
   4.8%
Asian - Japanese Heritage
1
   0.1%
2
   0.2%
2
   0.2%
1
   0.1%
6
   0.1%
Asian - East Asian Heritage
8
   0.6%
10
   0.8%
10
   0.8%
10
   0.8%
38
   0.8%
1.Primary Outcome
Title Percentage 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 ≥200 milli International Unit/Milliliter (mIU/mL) among subjects who were seronegative (antibody concentration <150 mIU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
According to protocol (ATP) cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule
Arm/Group Title INV_MMR _L1 Group INV_MMR _L2 Group INV_MMR _L3 Group
Hide Arm/Group Description:
Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Overall Number of Participants Analyzed 1083 1069 1096
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
Anti-measles ≥ 150 mIU/mL
98.2
(97.3 to 98.9)
98.9
(98.0 to 99.4)
98.1
(97.1 to 98.8)
Anti-measles ≥ 200 mIU/mL
98.1
(97.1 to 98.8)
98.6
(97.7 to 99.2)
97.8
(96.8 to 98.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INV_MMR _L1 Group, INV_MMR _L2 Group
Comments Difference between groups (INV_MMR_L1 Group minus INV_MMR_L2 Group) in percentage of subjects with anti-measles antibody concentration ≥200 mIU/mL.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For each pair-wise comparison, the 2-sided 95% confidence interval (CI) on the lot difference in seroresponse rates should be within the [-5%;5%] margin for antibodies to measles virus.
Method of Estimation Estimation Parameter Difference in seroresponse rate
Estimated Value -0.54
Confidence Interval (2-Sided) 95%
-1.69 to 0.58
Estimation Comments Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection INV_MMR _L2 Group, INV_MMR _L3 Group
Comments Difference between groups (INV_MMR_L2 Group minus INV_MMR_L3 Group) in percentage of subjects with anti-measles antibody concentration ≥200 mIU/mL.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For each pair-wise comparison, the 2-sided 95% confidence interval (CI) on the lot difference in seroresponse rates should be within the [-5%;5%] margin for antibodies to measles virus.
Method of Estimation Estimation Parameter Difference in seroresponse rate
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
-0.35 to 1.98
Estimation Comments Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection INV_MMR _L1 Group, INV_MMR _L3 Group
Comments Difference between groups (INV_MMR_L1 Group minus INV_MMR_L3 Group) in percentage of subjects with anti-measles antibody concentration ≥200 mIU/mL.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For each pair-wise comparison, the 2-sided 95% confidence interval (CI) on the lot difference in seroresponse rates should be within the [-5%;5%] margin for antibodies to measles virus.
Method of Estimation Estimation Parameter Difference in seroresponse rate
Estimated Value 0.25
Confidence Interval (2-Sided) 95%
-0.98 to 1.50
Estimation Comments Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.
2.Primary Outcome
Title Anti-measles Virus Antibody Concentrations
Hide Description Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule
Arm/Group Title INV_MMR _L1 Group INV_MMR _L2 Group INV_MMR _L3 Group
Hide Arm/Group Description:
Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Overall Number of Participants Analyzed 1083 1069 1096
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
2970.3
(2813.2 to 3136.2)
3023.6
(2864.5 to 3191.6)
3058.3
(2893.9 to 3232.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INV_MMR _L1 Group, INV_MMR _L2 Group
Comments Adjusted GMC ratio (INV_MMR_L1 Group divided by INV_MMR_L2 Group) for antibodies to measles virus at Day 42.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to measles.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments 95% CI for GMC of each INV_MMR lots pair was computed using ANOVA (3 INV_MMR lot groups & country as fixed effects) on log-transformed concentrations.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.91 to 1.06
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection INV_MMR _L1 Group, INV_MMR _L3 Group
Comments Adjusted GMC ratio (INV_MMR_L1 Group divided by INV_MMR_L3 Group) for antibodies to measles virus at Day 42.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to measles.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments 95% CI for GMC of each INV_MMR lots pair was computed using ANOVA (3 INV_MMR lot groups & country as fixed effects) on log-transformed concentrations.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.90 to 1.05
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection INV_MMR _L1 Group, INV_MMR _L2 Group
Comments Adjusted GMC ratio (INV_MMR_L2 Group divided by INV_MMR_L1 Group) for antibodies to measles virus at Day 42.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to measles.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments 95% CI for GMC of each INV_MMR lots pair was computed using ANOVA (3 INV_MMR lot groups & country as fixed effects) on log-transformed concentrations.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.94 to 1.09
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection INV_MMR _L2 Group, INV_MMR _L3 Group
Comments Adjusted GMC ratio (INV_MMR_L2 Group divided by INV_MMR_L3 Group) for antibodies to measles virus at Day 42.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to measles.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments 95% CI for GMC of each INV_MMR lots pair was computed using ANOVA (3 INV_MMR lot groups & country as fixed effects) on log-transformed concentrations.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.91 to 1.06
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection INV_MMR _L1 Group, INV_MMR _L3 Group
Comments Adjusted GMC ratio (INV_MMR_L3 Group divided by INV_MMR_L1 Group) for antibodies to measles virus at Day 42.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to measles.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments 95% CI for GMC of each INV_MMR lots pair was computed using ANOVA (3 INV_MMR lot groups & country as fixed effects) on log-transformed concentrations.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.95 to 1.11
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection INV_MMR _L2 Group, INV_MMR _L3 Group
Comments Adjusted GMC ratio (INV_MMR_L3 Group divided by INV_MMR_L2 Group) for antibodies to measles virus at Day 42.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to measles.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments 95% CI for GMC of each INV_MMR lots pair was computed using ANOVA (3 INV_MMR lot groups & country as fixed effects) on log-transformed concentrations.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.94 to 1.09
Estimation Comments [Not Specified]
3.Primary Outcome
Title Percentage 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 Unit/Milliliter (EU/mL) among subjects who were seronegative (antibody concentrations <5 EU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule
Arm/Group Title INV_MMR_L1 Group INV_MMR_L2 Group INV_MMR_L3 Group
Hide Arm/Group Description:
Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Overall Number of Participants Analyzed 1062 1047 1078
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
Anti-mumps ≥ 5 EU/mL
99.7
(99.2 to 99.9)
99.3
(98.6 to 99.7)
99.2
(98.4 to 99.6)
Anti-mumps ≥ 10 EU/mL
98.6
(97.7 to 99.2)
98.6
(97.6 to 99.2)
98.0
(96.9 to 98.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INV_MMR_L1 Group, INV_MMR_L2 Group
Comments Difference between groups (INV_MMR_L1 Group minus INV_MMR_L2 Group) in percentage of subjects with anti-mumps antibody concentration ≥10 EU/mL.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the [-5%;5%] margin for antibodies to mumps virus.
Method of Estimation Estimation Parameter Difference in seroresponse rate
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-1.05 to 1.09
Estimation Comments Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection INV_MMR_L1 Group, INV_MMR_L3 Group
Comments Difference between groups (INV_MMR_L1 Group minus INV_MMR_L3 Group) in percentage of subjects with anti-mumps antibody concentration ≥10 EU/mL.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the [-5%;5%] margin for antibodies to mumps virus.
Method of Estimation Estimation Parameter Difference in seroresponse rate
Estimated Value 0.63
Confidence Interval (2-Sided) 95%
-0.50 to 1.81
Estimation Comments Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection INV_MMR_L2 Group, INV_MMR_L3 Group
Comments Difference between groups (INV_MMR_L2 Group minus INV_MMR_L3 Group) in percentage of subjects with anti-mumps antibody concentration ≥10 EU/mL.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the [-5%;5%] margin for antibodies to mumps virus.
Method of Estimation Estimation Parameter Difference in seroresponse rate
Estimated Value 0.61
Confidence Interval (2-Sided) 95%
-0.53 to 1.79
Estimation Comments Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.
4.Primary Outcome
Title Anti-mumps Virus Antibody Concentration
Hide Description Antibody concentrations were expressed as GMCs in EU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule
Arm/Group Title INV_MMR_L1 Group INV_MMR_L2 Group INV_MMR_L3 Group
Hide Arm/Group Description:
Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Overall Number of Participants Analyzed 1062 1047 1078
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
71.7
(68.3 to 75.2)
76.9
(73.2 to 80.8)
69.0
(65.5 to 72.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INV_MMR_L1 Group, INV_MMR_L2 Group
Comments Adjusted GMC ratio (INV_MMR_L1 Group divided by INV_MMR_L2 Group) for antibodies to mumps virus at Day 42.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to mumps.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments 95% CI for GMC of each INV_MMR lots pair was computed using ANOVA (3 INV_MMR lot groups & country as fixed effects) on log-transformed concentrations.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.87 to 1.00
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection INV_MMR_L1 Group, INV_MMR_L3 Group
Comments Adjusted GMC ratio (INV_MMR_L1 Group divided by INV_MMR_L3 Group) for antibodies to mumps virus at Day 42.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to mumps.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments 95% CI for GMC of each INV_MMR lots pair was computed using ANOVA (3 INV_MMR lot groups & country as fixed effects) on log-transformed concentrations.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.97 to 1.11
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection INV_MMR_L1 Group, INV_MMR_L2 Group
Comments Adjusted GMC ratio (INV_MMR_L2 Group divided by INV_MMR_L1 Group) for antibodies to mumps virus at Day 42.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to mumps.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments 95% CI for GMC of each INV_MMR lots pair was computed using ANOVA (3 INV_MMR lot groups & country as fixed effects) on log-transformed concentrations.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
1.00 to 1.15
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection INV_MMR_L2 Group, INV_MMR_L3 Group
Comments Adjusted GMC ratio (INV_MMR_L2 Group divided by INV_MMR_L3 Group) for antibodies to mumps virus at Day 42.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to mumps.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments 95% CI for GMC of each INV_MMR lots pair was computed using ANOVA (3 INV_MMR lot groups & country as fixed effects) on log-transformed concentrations.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
1.04 to 1.19
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection INV_MMR_L1 Group, INV_MMR_L3 Group
Comments Adjusted GMC ratio (INV_MMR_L3 Group divided by INV_MMR_L1 Group) for antibodies to mumps virus at Day 42.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to mumps.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments 95% CI for GMC of each INV_MMR lots pair was computed using ANOVA (3 INV_MMR lot groups & country as fixed effects) on log-transformed concentrations.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.90 to 1.03
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection INV_MMR_L2 Group, INV_MMR_L3 Group
Comments Adjusted GMC ratio (INV_MMR_L3 Group divided by INV_MMR_L2 Group) for antibodies to mumps virus at Day 42.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to mumps.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments 95% CI for GMC of each INV_MMR lots pair was computed using ANOVA (3 INV_MMR lot groups & country as fixed effects) on log-transformed concentrations.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.84 to 0.96
Estimation Comments [Not Specified]
5.Primary Outcome
Title Percentage 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 Unit/Milliliter (IU/mL) among subjects who were seronegative (antibody concentrations <4 IU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule
Arm/Group Title INV_MMR_L1 Group INV_MMR_L2 Group INV_MMR_L3 Group
Hide Arm/Group Description:
Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Overall Number of Participants Analyzed 1083 1067 1095
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
Anti-rubella ≥ 4 IU/mL
99.4
(98.8 to 99.8)
99.7
(99.2 to 99.9)
99.4
(98.7 to 99.7)
Anti-rubella ≥ 10 IU/mL
97.2
(96.1 to 98.1)
97.1
(95.9 to 98.0)
97.7
(96.6 to 98.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INV_MMR_L1 Group, INV_MMR_L2 Group
Comments Difference between groups (INV_MMR_L1 Group minus INV_MMR_L2 Group) in percentage of subjects with anti-rubella antibody concentration ≥10 IU/mL.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the [-5%;5%] margin for antibodies to rubella virus.
Method of Estimation Estimation Parameter Difference in seroresponse rate
Estimated Value 0.14
Confidence Interval (2-Sided) 95%
-1.3 to 1.58
Estimation Comments Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection INV_MMR_L1 Group, INV_MMR_L3 Group
Comments Difference between groups (INV_MMR_L1 Group minus INV_MMR_L3 Group) in percentage of subjects with anti-rubella antibody concentration ≥10 IU/mL.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the [-5%;5%] margin for antibodies to rubella virus.
Method of Estimation Estimation Parameter Difference in seroresponse rate
Estimated Value -0.49
Confidence Interval (2-Sided) 95%
-1.86 to 0.86
Estimation Comments Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection INV_MMR_L2 Group, INV_MMR_L3 Group
Comments Difference between groups (INV_MMR_L2 Group minus INV_MMR_L3 Group) in percentage of subjects with anti-rubella antibody concentration ≥10 IU/mL.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the [-5%;5%] margin for antibodies to rubella virus.
Method of Estimation Estimation Parameter Difference in seroresponse rate
Estimated Value -0.62
Confidence Interval (2-Sided) 95%
-2.02 to 0.74
Estimation Comments Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.
6.Primary Outcome
Title Anti-rubella Virus Antibody Concentration
Hide Description Antibody concentrations were expressed as GMCs in IU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule
Arm/Group Title INV_MMR_L1 Group INV_MMR_L2 Group INV_MMR_L3 Group
Hide Arm/Group Description:
Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Overall Number of Participants Analyzed 1083 1067 1095
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
57.2
(54.4 to 60.1)
53.1
(50.5 to 55.7)
57.0
(54.3 to 59.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INV_MMR_L1 Group, INV_MMR_L2 Group
Comments

Adjusted GMC ratio (INV_MMR_L1 Group divided by INV_MMR_L2 Group) for antibodies to rubella virus at Day 42.

.

Type of Statistical Test Non-Inferiority or Equivalence
Comments For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to measles.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments 95% CI for GMC of each INV_MMR lots pair was computed using ANOVA (3 INV_MMR lot groups & country as fixed effects) on log-transformed concentrations.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
1.01 to 1.15
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection INV_MMR_L1 Group, INV_MMR_L3 Group
Comments Adjusted GMC ratio (INV_MMR_L1 Group divided by INV_MMR_L3 Group) for antibodies to rubella virus at Day 42.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to measles.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments 95% CI for GMC of each INV_MMR lots pair was computed using ANOVA (3 INV_MMR lot groups & country as fixed effects) on log-transformed concentrations.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.94 to 1.07
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection INV_MMR_L1 Group, INV_MMR_L2 Group
Comments Adjusted GMC ratio (INV_MMR_L2 Group divided by INV_MMR_L1 Group) for antibodies to rubella virus at Day 42.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to measles.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments 95% CI for GMC of each INV_MMR lots pair was computed using ANOVA (3 INV_MMR lot groups & country as fixed effects) on log-transformed concentrations.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.87 to 0.99
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection INV_MMR_L2 Group, INV_MMR_L3 Group
Comments Adjusted GMC ratio (INV_MMR_L2 Group divided by INV_MMR_L3 Group) for antibodies to rubella virus at Day 42.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to measles.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments 95% CI for GMC of each INV_MMR lots pair was computed using ANOVA (3 INV_MMR lot groups & country as fixed effects) on log-transformed concentrations.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.87 to 0.99
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection INV_MMR_L1 Group, INV_MMR_L3 Group
Comments Adjusted GMC ratio (INV_MMR_L3 Group divided by INV_MMR_L1 Group) for antibodies to rubella virus at Day 42.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to measles.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments 95% CI for GMC of each INV_MMR lots pair was computed using ANOVA (3 INV_MMR lot groups & country as fixed effects) on log-transformed concentrations.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.93 to 1.07
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection INV_MMR_L2 Group, INV_MMR_L3 Group
Comments Adjusted GMC ratio (INV_MMR_L3 Group divided by INV_MMR_L2 Group) for antibodies to rubella virus at Day 42.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to measles.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments 95% CI for GMC of each INV_MMR lots pair was computed using ANOVA (3 INV_MMR lot groups & country as fixed effects) on log-transformed concentrations.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
1.01 to 1.15
Estimation Comments [Not Specified]
7.Primary Outcome
Title Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups
Hide Description Seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥200 mIU/mL among subjects who were seronegative (antibody concentration <150 mIU/mL) before vaccination. Criteria to demonstrate an acceptable immune response for INV_MMR in terms of seroresponse rates to measles virus at Day 42: The LL of 2-sided 95% CI for the seroresponse rate for the pooled INV_MMR lots is ≥90% for antibodies to measles virus.
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.
Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.
Overall Number of Participants Analyzed 3248 1137
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
Anti-measles ≥ 150 mIU/mL
98.4
(97.9 to 98.8)
98.1
(97.1 to 98.8)
Anti-measles ≥ 200 mIU/mL
98.2
(97.6 to 98.6)
98.0
(97.0 to 98.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INV_MMR Group, COM_MMR Group
Comments Difference in percentage (INV_MMR Group minus COM_MMR Group) of subjects with anti-measles antibody concentration at Day 42.
Type of Statistical Test Non-Inferiority
Comments The Lower Limit (LL) of 2-sided 95 % CI for the difference in seroresponse (INV_MMR Group minus COM_MMR Group) should be ≥-5% for antibodies to measles virus.
Method of Estimation Estimation Parameter Difference in seroresponse rate
Estimated Value 0.18
Confidence Interval (2-Sided) 95%
-0.68 to 1.25
Estimation Comments Asymptotic standardized 95% CIs for the difference in seroresponse rate.
8.Primary Outcome
Title Anti-measles Virus Antibody Concentrations in Pooled MMR Groups
Hide Description Antibody concentrations were expressed as GMCs in mIU/mL.
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.
Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.
Overall Number of Participants Analyzed 3248 1137
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
3017.4
(2923.9 to 3113.8)
3074.4
(2911.0 to 3246.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INV_MMR Group, COM_MMR Group
Comments Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for antibodies to measles virus at Day 42.
Type of Statistical Test Non-Inferiority
Comments The LL of the 2-sided 95% CI on GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.67 for antibodies to measles virus.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments 95% CI for GMC ratio (INV_MMR over COM_ MMR) was computed using ANOVA (vaccine groups & country as fixed effects) on log-transformed concentrations.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.93 to 1.05
Estimation Comments [Not Specified]
9.Primary Outcome
Title Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups
Hide Description Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥10 EU/mL among subjects who were seronegative (antibody concentrations <5 EU/mL) before vaccination.
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.
Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.
Overall Number of Participants Analyzed 3187 1107
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
Anti-mumps ≥ 5 EU/mL
99.4
(99.1 to 99.6)
99.3
(98.6 to 99.7)
Anti-mumps ≥ 10 EU/mL
98.4
(97.9 to 98.8)
97.6
(96.5 to 98.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INV_MMR Group, COM_MMR Group
Comments Difference in percentage (INV_MMR Group minus COM_MMR Group) of subjects with anti-mumps antibody concentration at Day 42.
Type of Statistical Test Non-Inferiority
Comments The LL of 2-sided 95 % CI for the difference in seroresponse (INV_MMR Group minus COM_MMR Group) should be ≥-5% for antibodies to mumps virus.
Method of Estimation Estimation Parameter Difference in seroresponse rate
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
-0.1 to 1.96
Estimation Comments Asymptotic standardized 95% CIs for the difference in seroresponse rate.
10.Primary Outcome
Title Anti-mumps Virus Antibody Concentration in Pooled MMR Groups
Hide Description Antibody concentrations were expressed as GMCs in EU/mL.
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.
Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.
Overall Number of Participants Analyzed 3187 1107
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
72.4
(70.4 to 74.5)
69.1
(65.7 to 72.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INV_MMR Group, COM_MMR Group
Comments Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for antibodies to mumps virus at Day 42.
Type of Statistical Test Non-Inferiority
Comments The LL of the 2-sided 95% CI on GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.67 for antibodies to mumps virus.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments 95% CI for GMC ratio (INV_MMR over COM_ MMR) was computed using ANOVA (vaccine groups & country as fixed effects) on log-transformed concentrations.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.99 to 1.11
Estimation Comments [Not Specified]
11.Primary Outcome
Title Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups
Hide Description Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥10 IU/mL among subjects who were seronegative (antibody concentrations <4 IU/mL) before vaccination. Criteria to demonstrate an acceptable immune response for INV_MMR in terms of seroresponse rates to rubella virus at Day 42: The LL of 2-sided 95% CI for the seroresponse rate for the pooled INV_MMR lots is ≥90% for antibodies to rubella virus.
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.
Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.
Overall Number of Participants Analyzed 3245 1135
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
Anti-rubella ≥ 4 IU/mL
99.5
(99.2 to 99.7)
99.6
(99.0 to 99.9)
Anti-rubella ≥ 10 IU/mL
97.3
(96.7 to 97.9)
98.5
(97.6 to 99.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INV_MMR Group, COM_MMR Group
Comments Difference in percentage (INV_MMR Group minus COM_MMR Group) of subjects with anti-rubella antibody concentration at Day 42.
Type of Statistical Test Non-Inferiority
Comments The LL of 2-sided 95 % CI for the difference in seroresponse (INV_MMR Group minus COM_MMR Group) should be ≥-5% for antibodies to rubella virus.
Method of Estimation Estimation Parameter Difference in seroresponse rate
Estimated Value -1.15
Confidence Interval (2-Sided) 95%
-2.00 to -0.15
Estimation Comments Asymptotic standardized 95% CIs for the difference in seroresponse rate.
12.Primary Outcome
Title Anti-rubella Virus Antibody Concentration in Pooled MMR Groups
Hide Description Antibody concentrations were expressed as GMCs in IU/mL.
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.
Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.
Overall Number of Participants Analyzed 3245 1135
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
55.7
(54.2 to 57.3)
64.0
(61.1 to 67.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INV_MMR Group, COM_MMR Group
Comments Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for antibodies to rubella virus at Day 42.
Type of Statistical Test Non-Inferiority
Comments The LL of the 2-sided 95% CI on GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.67 for antibodies to measles virus.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments 95% CI for GMC ratio (INV_MMR over COM_ MMR) was computed using ANOVA (vaccine groups & country as fixed effects) on log-transformed concentrations.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.83 to 0.92
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Percentage of Subjects With an Anti-Varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off Value in US Sub-cohort of Pooled MMR Groups
Hide Description Seroresponse was defined as post-vaccination anti-VZV antibody concentration ≥75 mIU/mL among subjects who were seronegative (antibody concentration <25 mIU/mL) before vaccination.
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
ATP cohort for immunogenicity included subjects from US sub-cohort who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.
Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.
Overall Number of Participants Analyzed 1492 540
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
Anti-VZV ≥ 25 mIU/mL
99.7
(99.3 to 99.9)
99.6
(98.7 to 100)
Anti-VZV ≥ 75 mIU/mL
92.2
(90.7 to 93.5)
90.9
(88.2 to 93.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INV_MMR Group, COM_MMR Group
Comments In US sub-cohort: Difference in percentage (INV_MMR Group minus COM_MMR Group) of subjects with anti-VZV antibody concentration at Day 42.
Type of Statistical Test Non-Inferiority
Comments The LL of 2-sided 95 % CI for the difference in seroresponse (pooled INV_MMR Group minus pooled COM_MMR Group) should be ≥-10% for antibodies to VZV.
Method of Estimation Estimation Parameter Difference in seroresponse rate
Estimated Value 1.30
Confidence Interval (2-Sided) 95%
-1.31 to 4.29
Estimation Comments Asymptotic standardized 95% CIs for the difference in seroresponse rate.
14.Secondary Outcome
Title Anti-VZV Virus Antibody Concentration in US Sub-cohort of Pooled MMR Groups
Hide Description Antibody concentrations were expressed as GMCs in mIU/mL.
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
ATP cohort for immunogenicity included subjects from US sub-cohort who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.
Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.
Overall Number of Participants Analyzed 1492 540
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
169.6
(164.3 to 175)
167.2
(158.2 to 176.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INV_MMR Group, COM_MMR Group
Comments In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for antibodies to VZV virus at Day 42.
Type of Statistical Test Non-Inferiority
Comments The LL of the 2-sided 95% CI on GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.67 for antibodies to VZV.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments 95% CI for GMC ratio (INV_MMR over COM_ MMR) was computed using ANOVA (vaccine groups & country as fixed effects) on log-transformed concentrations.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.95 to 1.08
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Percentage of Subjects With an Anti-HAV Antibody Concentration Equal to or Above the Cut-off Value in US Sub-cohort of Pooled MMR Groups
Hide Description Percentage of subjects with an Anti-HAV antibody concentration equal to or above 15 mIU/mL were reported.
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
ATP cohort for immunogenicity included subjects from US sub-cohort who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.
Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.
Overall Number of Participants Analyzed 783 285
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
88.9
(86.5 to 91.0)
87.4
(82.9 to 91.0)
16.Secondary Outcome
Title Anti-HAV Antibody Concentrations in US Sub-cohort of Pooled MMR Groups
Hide Description Antibody concentrations were expressed as GMCs in mIU/mL.
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
ATP cohort for immunogenicity included subjects from US sub-cohort who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.
Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.
Overall Number of Participants Analyzed 783 285
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
42.0
(39.3 to 44.8)
42.4
(38.1 to 47.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INV_MMR Group, COM_MMR Group
Comments In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for antibodies to HAV virus at Day 42.
Type of Statistical Test Non-Inferiority
Comments The LL of the 2-sided 95% CI on GMC ratio (INV_MMR Group over COM_MMR Group) was ≥0.5 for antibodies to HAV virus.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments 95% CI for GMC ratio (INV_MMR over COM_ MMR) was computed using ANOVA (vaccine groups & country as fixed effects) on log-transformed concentrations.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.86 to 1.11
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Anti-S.Pneumoniae Antibody Concentration in US Sub-cohort of Pooled MMR Groups
Hide Description Antibody concentrations were expressed as GMCs in microgram/Milliliter (µg/mL).
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
ATP cohort for immunogenicity included subjects from US sub-cohort who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule
Arm/Group Title INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.
Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.
Overall Number of Participants Analyzed 759 266
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
anti-PnPS 1 antibody Number Analyzed 759 participants 266 participants
2.257
(2.121 to 2.402)
2.425
(2.195 to 2.679)
anti-PnPS 3 antibody Number Analyzed 758 participants 265 participants
0.506
(0.481 to 0.533)
0.496
(0.454 to 0.542)
anti-PnPS 4 antibody Number Analyzed 753 participants 266 participants
1.618
(1.518 to 1.725)
1.872
(1.676 to 2.091)
anti-PnPS 5 antibody Number Analyzed 757 participants 266 participants
2.106
(1.991 to 2.228)
2.280
(2.085 to 2.493)
anti-PnPS 6A antibody Number Analyzed 759 participants 266 participants
5.840
(5.508 to 6.192)
5.743
(5.233 to 6.304)
anti-PnPS 6B antibody Number Analyzed 758 participants 266 participants
5.872
(5.504 to 6.265)
5.838
(5.239 to 6.505)
anti-PnPS 7F antibody Number Analyzed 758 participants 266 participants
3.691
(3.489 to 3.905)
3.814
(3.484 to 4.176)
anti-PnPS 9V antibody Number Analyzed 759 participants 266 participants
2.318
(2.183 to 2.461)
2.282
(2.065 to 2.521)
anti-PnPS 14 antibody Number Analyzed 757 participants 266 participants
6.578
(6.155 to 7.029)
7.053
(6.368 to 7.811)
anti-PnPS 18C antibody Number Analyzed 759 participants 265 participants
2.102
(1.973 to 2.241)
2.217
(1.990 to 2.470)
anti-PnPS 19A antibody Number Analyzed 759 participants 265 participants
4.731
(4.461 to 5.017)
4.821
(4.372 to 5.317)
anti-PnPS 19F antibody Number Analyzed 759 participants 266 participants
4.251
(4.013 to 4.504)
4.260
(3.872 to 4.687)
anti-PnPS 23F antibody Number Analyzed 742 participants 256 participants
2.198
(2.051 to 2.355)
2.291
(2.025 to 2.592)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INV_MMR Group, COM_MMR Group
Comments In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 1 antibody at Day 42.
Type of Statistical Test Non-Inferiority
Comments The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments 95% CI for GMC ratio (INV_MMR Group over the COM_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.85 to 1.05
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection INV_MMR Group, COM_MMR Group
Comments In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 3 antibody at Day 42.
Type of Statistical Test Non-Inferiority
Comments The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments 95% CI for GMC ratio (INV_MMR Group over the COM_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.91 to 1.08
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection INV_MMR Group, COM_MMR Group
Comments In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 4 antibody at Day 42.
Type of Statistical Test Non-Inferiority
Comments The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments 95% CI for GMC ratio (INV_MMR Group over the COM_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 0.88
Confidence Interval 95%
0.79 to 0.98
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection INV_MMR Group, COM_MMR Group
Comments In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 5 antibody at Day 42.
Type of Statistical Test Non-Inferiority
Comments The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments 95% CI for GMC ratio (INV_MMR Group over the COM_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.83 to 1.01
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection INV_MMR Group, COM_MMR Group
Comments In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 6A antibody at Day 42.
Type of Statistical Test Non-Inferiority
Comments The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments 95% CI for GMC ratio (INV_MMR Group over the COM_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.92 to 1.11
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection INV_MMR Group, COM_MMR Group
Comments In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 6B antibody at Day 42.
Type of Statistical Test Non-Inferiority
Comments The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments 95% CI for GMC ratio (INV_MMR Group over the COM_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.89 to 1.09
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection INV_MMR Group, COM_MMR Group
Comments In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 7F antibody at Day 42.
Type of Statistical Test Non-Inferiority
Comments The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments 95% CI for GMC ratio (INV_MMR Group over the COM_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.86 to 1.03
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection INV_MMR Group, COM_MMR Group
Comments In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 9V antibody at Day 42.
Type of Statistical Test Non-Inferiority
Comments The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments 95% CI for GMC ratio (INV_MMR Group over the COM_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.90 to 1.08
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection INV_MMR Group, COM_MMR Group
Comments In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 14 antibody at Day 42.
Type of Statistical Test Non-Inferiority
Comments The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments 95% CI for GMC ratio (INV_MMR Group over the COM_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.81 to 1.02
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection INV_MMR Group, COM_MMR Group
Comments In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 18C antibody at Day 42.
Type of Statistical Test Non-Inferiority
Comments The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments 95% CI for GMC ratio (INV_MMR Group over the COM_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.84 to 1.02
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection INV_MMR Group, COM_MMR Group
Comments In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 19A antibody at Day 42.
Type of Statistical Test Non-Inferiority
Comments The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments 95% CI for GMC ratio (INV_MMR Group over the COM_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.87 to 1.07
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection INV_MMR Group, COM_MMR Group
Comments In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 19F antibody at Day 42.
Type of Statistical Test Non-Inferiority
Comments The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments 95% CI for GMC ratio (INV_MMR Group over the COM_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.87 to 1.06
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection INV_MMR Group, COM_MMR Group
Comments In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 23F antibody at Day 42.
Type of Statistical Test Non-Inferiority
Comments The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments 95% CI for GMC ratio (INV_MMR Group over the COM_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.
Method of Estimation Estimation Parameter Adjusted GMC ratio
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.85 to 1.06
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Number of Subjects With Any Solicited Local Adverse Events (AEs)
Hide Description Assessed solicited local AEs were pain, redness and swelling. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.
Time Frame During the 4-days (Days 0-3) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
Total Vaccinated cohort (TVC) included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented
Arm/Group Title INV_MMR_L1 Group INV_MMR_L2 Group INV_MMR_L3 Group INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.
Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.
Overall Number of Participants Analyzed 1186 1175 1194 3555 1242
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain
331
  27.9%
315
  26.8%
273
  22.9%
919
  25.9%
349
  28.1%
Any Redness
296
  25.0%
273
  23.2%
301
  25.2%
870
  24.5%
313
  25.2%
Any Swelling
116
   9.8%
99
   8.4%
103
   8.6%
318
   8.9%
133
  10.7%
19.Secondary Outcome
Title Number of Subjects With Any Solicited General AEs
Hide Description Assessed solicited general AEs were drowsiness, irritability and loss of appetite. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.
Time Frame During the 15-days (Days 0-14) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
TVC included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented
Arm/Group Title INV_MMR_L1 Group INV_MMR_L2 Group INV_MMR_L3 Group INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.
Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.
Overall Number of Participants Analyzed 1190 1176 1200 3566 1243
Measure Type: Count of Participants
Unit of Measure: Participants
Any Drowsiness
533
  44.8%
535
  45.5%
533
  44.4%
1601
  44.9%
586
  47.1%
Any Irritability/fussiness
764
  64.2%
729
  62.0%
765
  63.7%
2258
  63.3%
819
  65.9%
Any Loss of appetite
546
  45.9%
536
  45.6%
526
  43.8%
1608
  45.1%
548
  44.1%
20.Secondary Outcome
Title Number of Subjects Reporting Any Fever
Hide Description Any fever = Fever ≥ 38°C.
Time Frame During the 43-days (Days 0-42) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
TVC included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented
Arm/Group Title INV_MMR_L1 Group INV_MMR_L2 Group INV_MMR_L3 Group INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.
Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.
Overall Number of Participants Analyzed 1190 1176 1200 3566 1243
Measure Type: Count of Participants
Unit of Measure: Participants
404
  33.9%
422
  35.9%
418
  34.8%
1244
  34.9%
412
  33.1%
21.Secondary Outcome
Title Number of Subjects Reporting Any Rash
Hide Description Assessed were any localized or generalized rash, rash with fever, varicella-like rash, measles/rubella-like rash. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.
Time Frame During the 43-days (Days 0-42) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
TVC included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented
Arm/Group Title INV_MMR_L1 Group INV_MMR_L2 Group INV_MMR_L3 Group INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.
Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.
Overall Number of Participants Analyzed 1190 1176 1200 3566 1243
Measure Type: Count of Participants
Unit of Measure: Participants
Any Localized or Generalized
352
  29.6%
331
  28.1%
360
  30.0%
1043
  29.2%
378
  30.4%
Any with fever
106
   8.9%
123
  10.5%
118
   9.8%
347
   9.7%
104
   8.4%
Any Varicella like
87
   7.3%
78
   6.6%
85
   7.1%
250
   7.0%
85
   6.8%
Any Measles/Rubella like
71
   6.0%
88
   7.5%
76
   6.3%
235
   6.6%
77
   6.2%
22.Secondary Outcome
Title Number of Subjects Reporting Any MMR Specific Solicited AEs
Hide Description Assessed MMR specific solicited AEs were any suspected signs of meningism including febrile convulsions and parotid/salivary gland swelling. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.
Time Frame During the 43-days (Days 0-42) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
TVC included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented
Arm/Group Title INV_MMR_L1 Group INV_MMR_L2 Group INV_MMR_L3 Group INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.
Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.
Overall Number of Participants Analyzed 1190 1176 1200 3566 1243
Measure Type: Count of Participants
Unit of Measure: Participants
Any febrile convulsion
4
   0.3%
1
   0.1%
5
   0.4%
10
   0.3%
3
   0.2%
Any parotid/salivary gland swelling
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
23.Secondary Outcome
Title Number of Subjects Reporting Any Unsolicited AEs
Hide Description Unsolicited adverse event (AE) was defined as any adverse event reported in addition to those solicited during the clinical study and also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.
Time Frame During the 43-days (Days 0-42) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
TVC included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented
Arm/Group Title INV_MMR_L1 Group INV_MMR_L2 Group INV_MMR_L3 Group INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.
Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.
Overall Number of Participants Analyzed 1239 1232 1243 3714 1289
Measure Type: Count of Participants
Unit of Measure: Participants
615
  49.6%
633
  51.4%
609
  49.0%
1857
  50.0%
618
  47.9%
24.Secondary Outcome
Title Number of Subjects Reporting AEs of Specific Interest
Hide Description AEs of specific interest included new onset chronic disease (NOCD) (e.g., autoimmune disorders, asthma, type I diabetes, vasculitis, celiac disease, conditions associated with sub-acute or chronic thrombocytopenia and allergies) and AEs prompting emergency room (ER) visits.
Time Frame From Day 0 through the end of study (Day 180)
Hide Outcome Measure Data
Hide Analysis Population Description
TVC included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented
Arm/Group Title INV_MMR_L1 Group INV_MMR_L2 Group INV_MMR_L3 Group INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.
Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.
Overall Number of Participants Analyzed 1239 1232 1243 3714 1289
Measure Type: Count of Participants
Unit of Measure: Participants
NOCDs
40
   3.2%
39
   3.2%
49
   3.9%
128
   3.4%
48
   3.7%
AEs prompting ER visits
123
   9.9%
116
   9.4%
136
  10.9%
375
  10.1%
134
  10.4%
25.Secondary Outcome
Title Number of Subjects Reporting Any Serious Adverse Events (SAEs)
Hide Description SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity. Any SAE = Occurrence of SAE regardless of intensity grade or relation to vaccination.
Time Frame From Day 0 through the end of study (Day 180)
Hide Outcome Measure Data
Hide Analysis Population Description
TVC included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented
Arm/Group Title INV_MMR_L1 Group INV_MMR_L2 Group INV_MMR_L3 Group INV_MMR Group COM_MMR Group
Hide Arm/Group Description:
Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.
Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.
Overall Number of Participants Analyzed 1239 1232 1243 3714 1289
Measure Type: Count of Participants
Unit of Measure: Participants
21
   1.7%
28
   2.3%
28
   2.3%
77
   2.1%
25
   1.9%
Time Frame Serious Adverse Events: From Day 0 through the end of study (Day-180); Solicited local and general symptoms: During the 4-day (Day 0-3) and 15-days (Day 0-14) post-vaccination period; Unsolicited adverse events: During the 43-days (Day 0-42) post-vaccination period.
Adverse Event Reporting Description The analysis of the solicited symptoms was based on the Total Vaccinated cohort which included only children/doses with documented safety data (i.e., symptom screen/sheet completed).
 
Arm/Group Title INV_MMR_L1 Group INV_MMR_L2 Group INV_MMR_L3 Group INV_MMR Group COM_MMR Group
Hide Arm/Group Description Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency. Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.
All-Cause Mortality
INV_MMR_L1 Group INV_MMR_L2 Group INV_MMR_L3 Group INV_MMR Group COM_MMR Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/1239 (0.00%)      0/1232 (0.00%)      0/1243 (0.00%)      0/3714 (0.00%)      0/1289 (0.00%)    
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INV_MMR_L1 Group INV_MMR_L2 Group INV_MMR_L3 Group INV_MMR Group COM_MMR Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/1239 (1.69%)      28/1232 (2.27%)      28/1243 (2.25%)      77/3714 (2.07%)      25/1289 (1.94%)    
Blood and lymphatic system disorders           
Leukocytosis  1  0/1239 (0.00%)  0 1/1232 (0.08%)  1 0/1243 (0.00%)  0 1/3714 (0.03%)  1 2/1289 (0.16%)  2
Gastrointestinal disorders           
Diarrhoea  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 1/1243 (0.08%)  1 1/3714 (0.03%)  1 1/1289 (0.08%)  1
Enterocolitis  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 1/1243 (0.08%)  1 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Gastritis  1  1/1239 (0.08%)  1 0/1232 (0.00%)  0 0/1243 (0.00%)  0 1/3714 (0.03%)  1 0/1289 (0.00%)  0
General disorders           
Pyrexia  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 1/1243 (0.08%)  1 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Immune system disorders           
Milk allergy  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 0/1243 (0.00%)  0 0/3714 (0.00%)  0 1/1289 (0.08%)  1
Infections and infestations           
Abscess  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 1/1243 (0.08%)  1 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Bronchiolitis  1  1/1239 (0.08%)  1 2/1232 (0.16%)  2 1/1243 (0.08%)  1 4/3714 (0.11%)  4 2/1289 (0.16%)  2
Bronchitis  1  3/1239 (0.24%)  3 2/1232 (0.16%)  2 3/1243 (0.24%)  3 8/3714 (0.22%)  8 2/1289 (0.16%)  3
Cellulitis  1  1/1239 (0.08%)  1 0/1232 (0.00%)  0 2/1243 (0.16%)  2 3/3714 (0.08%)  3 0/1289 (0.00%)  0
Conjunctivitis  1  1/1239 (0.08%)  1 0/1232 (0.00%)  0 1/1243 (0.08%)  1 2/3714 (0.05%)  2 1/1289 (0.08%)  1
Croup infectious  1  0/1239 (0.00%)  0 1/1232 (0.08%)  1 0/1243 (0.00%)  0 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Escherichia urinary tract infection  1  1/1239 (0.08%)  1 0/1232 (0.00%)  0 0/1243 (0.00%)  0 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Gastroenteritis  1  1/1239 (0.08%)  1 1/1232 (0.08%)  1 2/1243 (0.16%)  2 4/3714 (0.11%)  4 2/1289 (0.16%)  2
Gastroenteritis adenovirus  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 1/1243 (0.08%)  1 1/3714 (0.03%)  1 1/1289 (0.08%)  1
Gastroenteritis rotavirus  1  0/1239 (0.00%)  0 1/1232 (0.08%)  1 0/1243 (0.00%)  0 1/3714 (0.03%)  1 1/1289 (0.08%)  1
Gastroenteritis viral  1  0/1239 (0.00%)  0 1/1232 (0.08%)  1 0/1243 (0.00%)  0 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Herpangina  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 1/1243 (0.08%)  1 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Laryngitis  1  0/1239 (0.00%)  0 1/1232 (0.08%)  1 0/1243 (0.00%)  0 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Mycoplasma infection  1  0/1239 (0.00%)  0 1/1232 (0.08%)  1 0/1243 (0.00%)  0 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Nasopharyngitis  1  0/1239 (0.00%)  0 1/1232 (0.08%)  1 0/1243 (0.00%)  0 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Neutropenic infection  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 0/1243 (0.00%)  0 0/3714 (0.00%)  0 1/1289 (0.08%)  1
Otitis media  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 4/1243 (0.32%)  4 4/3714 (0.11%)  4 2/1289 (0.16%)  2
Otitis media acute  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 0/1243 (0.00%)  0 0/3714 (0.00%)  0 1/1289 (0.08%)  1
Pharyngitis  1  1/1239 (0.08%)  1 1/1232 (0.08%)  1 0/1243 (0.00%)  0 2/3714 (0.05%)  2 0/1289 (0.00%)  0
Pneumococcal sepsis  1  0/1239 (0.00%)  0 1/1232 (0.08%)  1 0/1243 (0.00%)  0 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Pneumonia  1  2/1239 (0.16%)  2 1/1232 (0.08%)  1 3/1243 (0.24%)  3 6/3714 (0.16%)  6 0/1289 (0.00%)  0
Pneumonia bacterial  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 1/1243 (0.08%)  1 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Pneumonia respiratory syncytial viral  1  0/1239 (0.00%)  0 1/1232 (0.08%)  1 0/1243 (0.00%)  0 1/3714 (0.03%)  1 1/1289 (0.08%)  1
Pneumonia viral  1  1/1239 (0.08%)  1 2/1232 (0.16%)  2 1/1243 (0.08%)  1 4/3714 (0.11%)  4 0/1289 (0.00%)  0
Pyelonephritis acute  1  1/1239 (0.08%)  1 0/1232 (0.00%)  0 1/1243 (0.08%)  1 2/3714 (0.05%)  2 0/1289 (0.00%)  0
Respiratory syncytial virus bronchiolitis  1  1/1239 (0.08%)  1 1/1232 (0.08%)  1 1/1243 (0.08%)  1 3/3714 (0.08%)  3 1/1289 (0.08%)  1
Respiratory tract infection viral  1  0/1239 (0.00%)  0 1/1232 (0.08%)  1 0/1243 (0.00%)  0 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Rotavirus infection  1  1/1239 (0.08%)  1 0/1232 (0.00%)  0 0/1243 (0.00%)  0 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Subcutaneous abscess  1  1/1239 (0.08%)  1 0/1232 (0.00%)  0 0/1243 (0.00%)  0 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Tonsillitis  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 1/1243 (0.08%)  1 1/3714 (0.03%)  1 1/1289 (0.08%)  1
Upper respiratory tract infection  1  1/1239 (0.08%)  1 1/1232 (0.08%)  1 0/1243 (0.00%)  0 2/3714 (0.05%)  2 0/1289 (0.00%)  0
Viral infection  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 2/1243 (0.16%)  2 2/3714 (0.05%)  2 3/1289 (0.23%)  3
Viral pharyngitis  1  0/1239 (0.00%)  0 1/1232 (0.08%)  1 0/1243 (0.00%)  0 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Viral upper respiratory tract infection  1  1/1239 (0.08%)  1 0/1232 (0.00%)  0 0/1243 (0.00%)  0 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Injury, poisoning and procedural complications           
Burns second degree  1  0/1239 (0.00%)  0 1/1232 (0.08%)  1 1/1243 (0.08%)  1 2/3714 (0.05%)  2 0/1289 (0.00%)  0
Concussion  1  1/1239 (0.08%)  1 1/1232 (0.08%)  1 0/1243 (0.00%)  0 2/3714 (0.05%)  2 0/1289 (0.00%)  0
Femur fracture  1  0/1239 (0.00%)  0 1/1232 (0.08%)  1 0/1243 (0.00%)  0 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Foot fracture  1  0/1239 (0.00%)  0 1/1232 (0.08%)  1 0/1243 (0.00%)  0 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Head injury  1  2/1239 (0.16%)  2 0/1232 (0.00%)  0 0/1243 (0.00%)  0 2/3714 (0.05%)  2 0/1289 (0.00%)  0
Metabolism and nutrition disorders           
Dehydration  1  0/1239 (0.00%)  0 2/1232 (0.16%)  2 3/1243 (0.24%)  3 5/3714 (0.13%)  5 3/1289 (0.23%)  3
Hypoglycaemia  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 0/1243 (0.00%)  0 0/3714 (0.00%)  0 1/1289 (0.08%)  1
Type 1 diabetes mellitus  1  0/1239 (0.00%)  0 1/1232 (0.08%)  1 0/1243 (0.00%)  0 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Nervous system disorders           
Epilepsy  1  1/1239 (0.08%)  1 0/1232 (0.00%)  0 0/1243 (0.00%)  0 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Febrile convulsion  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 1/1243 (0.08%)  1 1/3714 (0.03%)  1 5/1289 (0.39%)  5
Loss of consciousness  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 1/1243 (0.08%)  1 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Seizure  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 2/1243 (0.16%)  2 2/3714 (0.05%)  2 0/1289 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Asthma  1  2/1239 (0.16%)  2 2/1232 (0.16%)  2 0/1243 (0.00%)  0 4/3714 (0.11%)  4 2/1289 (0.16%)  2
Bronchial hyperreactivity  1  0/1239 (0.00%)  0 3/1232 (0.24%)  3 0/1243 (0.00%)  0 3/3714 (0.08%)  3 3/1289 (0.23%)  3
Hypoxia  1  1/1239 (0.08%)  1 0/1232 (0.00%)  0 0/1243 (0.00%)  0 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Skin and subcutaneous tissue disorders           
Urticaria  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 0/1243 (0.00%)  0 0/3714 (0.00%)  0 2/1289 (0.16%)  2
Surgical and medical procedures           
Finger amputation  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 1/1243 (0.08%)  1 1/3714 (0.03%)  1 0/1289 (0.00%)  0
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
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Frequency Threshold for Reporting Other Adverse Events 0%
INV_MMR_L1 Group INV_MMR_L2 Group INV_MMR_L3 Group INV_MMR Group COM_MMR Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1089/1239 (87.89%)      1053/1232 (85.47%)      1090/1243 (87.69%)      3232/3714 (87.02%)      1138/1289 (88.29%)    
Blood and lymphatic system disorders           
Anaemia  1  0/1239 (0.00%)  0 2/1232 (0.16%)  2 4/1243 (0.32%)  4 6/3714 (0.16%)  6 0/1289 (0.00%)  0
Iron deficiency anaemia  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 0/1243 (0.00%)  0 0/3714 (0.00%)  0 1/1289 (0.08%)  1
Leukopenia  1  1/1239 (0.08%)  1 0/1232 (0.00%)  0 0/1243 (0.00%)  0 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Lymphadenitis  1  1/1239 (0.08%)  1 0/1232 (0.00%)  0 0/1243 (0.00%)  0 1/3714 (0.03%)  1 1/1289 (0.08%)  1
Lymphadenopathy  1  5/1239 (0.40%)  5 5/1232 (0.41%)  5 2/1243 (0.16%)  2 12/3714 (0.32%)  12 4/1289 (0.31%)  4
Ear and labyrinth disorders           
Cerumen impaction  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 1/1243 (0.08%)  1 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Deafness  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 1/1243 (0.08%)  1 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Ear pain  1  3/1239 (0.24%)  3 3/1232 (0.24%)  3 4/1243 (0.32%)  4 10/3714 (0.27%)  10 4/1289 (0.31%)  4
Ear swelling  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 1/1243 (0.08%)  1 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Eustachian tube dysfunction  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 0/1243 (0.00%)  0 0/3714 (0.00%)  0 1/1289 (0.08%)  1
Excessive cerumen production  1  0/1239 (0.00%)  0 1/1232 (0.08%)  1 0/1243 (0.00%)  0 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Otorrhoea  1  0/1239 (0.00%)  0 2/1232 (0.16%)  2 0/1243 (0.00%)  0 2/3714 (0.05%)  2 0/1289 (0.00%)  0
Eye disorders           
Conjunctivitis allergic  1  0/1239 (0.00%)  0 1/1232 (0.08%)  1 1/1243 (0.08%)  1 2/3714 (0.05%)  2 0/1289 (0.00%)  0
Dacryostenosis acquired  1  1/1239 (0.08%)  1 1/1232 (0.08%)  1 1/1243 (0.08%)  1 3/3714 (0.08%)  3 0/1289 (0.00%)  0
Eye discharge  1  0/1239 (0.00%)  0 2/1232 (0.16%)  2 1/1243 (0.08%)  1 3/3714 (0.08%)  3 0/1289 (0.00%)  0
Eye inflammation  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 0/1243 (0.00%)  0 0/3714 (0.00%)  0 1/1289 (0.08%)  1
Eye irritation  1  0/1239 (0.00%)  0 1/1232 (0.08%)  1 0/1243 (0.00%)  0 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Eye swelling  1  1/1239 (0.08%)  1 0/1232 (0.00%)  0 0/1243 (0.00%)  0 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Eyelid oedema  1  1/1239 (0.08%)  2 0/1232 (0.00%)  0 0/1243 (0.00%)  0 1/3714 (0.03%)  2 1/1289 (0.08%)  1
Hypermetropia  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 0/1243 (0.00%)  0 0/3714 (0.00%)  0 1/1289 (0.08%)  1
Lacrimation increased  1  1/1239 (0.08%)  1 0/1232 (0.00%)  0 0/1243 (0.00%)  0 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Lid sulcus deepened  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 1/1243 (0.08%)  1 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Strabismus  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 1/1243 (0.08%)  1 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Gastrointestinal disorders           
Abdominal discomfort  1  0/1239 (0.00%)  0 1/1232 (0.08%)  1 0/1243 (0.00%)  0 1/3714 (0.03%)  1 1/1289 (0.08%)  1
Abdominal pain  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 1/1243 (0.08%)  1 1/3714 (0.03%)  1 1/1289 (0.08%)  1
Abdominal pain upper  1  1/1239 (0.08%)  1 0/1232 (0.00%)  0 0/1243 (0.00%)  0 1/3714 (0.03%)  1 4/1289 (0.31%)  6
Anal fissure  1  0/1239 (0.00%)  0 1/1232 (0.08%)  1 0/1243 (0.00%)  0 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Aphthous ulcer  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 0/1243 (0.00%)  0 0/3714 (0.00%)  0 2/1289 (0.16%)  2
Chapped lips  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 0/1243 (0.00%)  0 0/3714 (0.00%)  0 1/1289 (0.08%)  1
Constipation  1  5/1239 (0.40%)  5 2/1232 (0.16%)  2 9/1243 (0.72%)  9 16/3714 (0.43%)  16 8/1289 (0.62%)  8
Diarrhoea  1  64/1239 (5.17%)  71 58/1232 (4.71%)  63 49/1243 (3.94%)  55 171/3714 (4.60%)  189 64/1289 (4.97%)  68
Dyspepsia  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 0/1243 (0.00%)  0 0/3714 (0.00%)  0 2/1289 (0.16%)  2
Dysphagia  1  0/1239 (0.00%)  0 1/1232 (0.08%)  1 0/1243 (0.00%)  0 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Faeces soft  1  0/1239 (0.00%)  0 1/1232 (0.08%)  1 1/1243 (0.08%)  1 2/3714 (0.05%)  2 0/1289 (0.00%)  0
Flatulence  1  2/1239 (0.16%)  2 2/1232 (0.16%)  2 1/1243 (0.08%)  1 5/3714 (0.13%)  5 1/1289 (0.08%)  1
Gastrooesophageal reflux disease  1  1/1239 (0.08%)  1 3/1232 (0.24%)  3 0/1243 (0.00%)  0 4/3714 (0.11%)  4 3/1289 (0.23%)  3
Gingival hypertrophy  1  0/1239 (0.00%)  0 1/1232 (0.08%)  1 0/1243 (0.00%)  0 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Gingival pain  1  1/1239 (0.08%)  1 0/1232 (0.00%)  0 1/1243 (0.08%)  1 2/3714 (0.05%)  2 0/1289 (0.00%)  0
Gingival swelling  1  0/1239 (0.00%)  0 2/1232 (0.16%)  2 0/1243 (0.00%)  0 2/3714 (0.05%)  2 1/1289 (0.08%)  1
Haematochezia  1  1/1239 (0.08%)  1 0/1232 (0.00%)  0 0/1243 (0.00%)  0 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Lip swelling  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 1/1243 (0.08%)  1 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Nausea  1  1/1239 (0.08%)  1 1/1232 (0.08%)  1 1/1243 (0.08%)  1 3/3714 (0.08%)  3 1/1289 (0.08%)  1
Oral contusion  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 0/1243 (0.00%)  0 0/3714 (0.00%)  0 2/1289 (0.16%)  2
Oral mucosal eruption  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 1/1243 (0.08%)  1 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Post-tussive vomiting  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 0/1243 (0.00%)  0 0/3714 (0.00%)  0 1/1289 (0.08%)  1
Ranula  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 1/1243 (0.08%)  1 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Rectal haemorrhage  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 1/1243 (0.08%)  1 1/3714 (0.03%)  1 0/1289 (0.00%)  0
Regurgitation  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 0/1243 (0.00%)  0 0/3714 (0.00%)  0 1/1289 (0.08%)  2
Salivary gland enlargement  1  0/1239 (0.00%)  0 1/1232 (0.08%)  1 1/1243 (0.08%)  1 2/3714 (0.05%)  2 0/1289 (0.00%)  0
Salivary gland pain  1  0/1239 (0.00%)  0 0/1232 (0.00%)  0 0/1243 (0.00%)  0 0/3714 (0.00%)  0