Trial Outcomes & Findings for 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 (NCT NCT01702428)

Last Updated: 2019-11-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

5016 participants

Primary outcome timeframe

At Day 42

Results posted on

2019-11-25

Participant Flow

13 subjects from 5016 were allocated subject number but no study vaccine was administered. Therefore, the number of subjects started is 5003.

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.

Participant milestones

Participant milestones
Measure	INV_MMR_L1 Group 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.	INV_MMR_L2 Group 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.	INV_MMR_L3 Group 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.	COM_MMR Group 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 Study STARTED	1239	1232	1243	1289
Overall Study COMPLETED	1175	1162	1190	1232
Overall Study NOT COMPLETED	64	70	53	57

Reasons for withdrawal

Reasons for withdrawal
Measure	INV_MMR_L1 Group 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.	INV_MMR_L2 Group 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.	INV_MMR_L3 Group 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.	COM_MMR Group 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 Study Adverse Event	2	0	0	0
Overall Study Lost to Follow-up	33	41	37	44
Overall Study Parents cannot assist to site	1	0	1	0
Overall Study Lost Coverage	0	0	0	1
Overall Study Lost Health Plan	3	5	0	2
Overall Study Mother transferred care	0	1	0	0
Overall Study Parents too busy	1	0	0	0
Overall Study Protocol Violation	3	0	1	0
Overall Study Withdrawal by Subject	21	23	14	10

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	INV_MMR_L1 Group n=1239 Participants 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.	INV_MMR_L2 Group n=1232 Participants 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.	INV_MMR_L3 Group n=1243 Participants 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.	COM_MMR Group n=1289 Participants 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 n=5003 Participants Total of all reporting groups
Age, Continuous	12.3 Months STANDARD_DEVIATION 0.7 • n=5 Participants	12.3 Months STANDARD_DEVIATION 0.7 • n=7 Participants	12.3 Months STANDARD_DEVIATION 0.7 • n=5 Participants	12.3 Months STANDARD_DEVIATION 0.7 • n=4 Participants	12.3 Months STANDARD_DEVIATION 0.7 • n=21 Participants
Sex: Female, Male Female	607 Participants n=5 Participants	594 Participants n=7 Participants	615 Participants n=5 Participants	618 Participants n=4 Participants	2434 Participants n=21 Participants
Sex: Female, Male Male	632 Participants n=5 Participants	638 Participants n=7 Participants	628 Participants n=5 Participants	671 Participants n=4 Participants	2569 Participants n=21 Participants
Race/Ethnicity, Customized White - Arabic / North African Heritage	5 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants	20 Participants n=21 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	14 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	9 Participants n=4 Participants	36 Participants n=21 Participants
Race/Ethnicity, Customized Other	170 Participants n=5 Participants	155 Participants n=7 Participants	162 Participants n=5 Participants	163 Participants n=4 Participants	650 Participants n=21 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants	2 Participants n=4 Participants	11 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	25 Participants n=5 Participants	37 Participants n=7 Participants	33 Participants n=5 Participants	31 Participants n=4 Participants	126 Participants n=21 Participants
Race/Ethnicity, Customized White - Caucasian / European Heritage	932 Participants n=5 Participants	938 Participants n=7 Participants	944 Participants n=5 Participants	970 Participants n=4 Participants	3784 Participants n=21 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	21 Participants n=5 Participants	25 Participants n=7 Participants	21 Participants n=5 Participants	26 Participants n=4 Participants	93 Participants n=21 Participants
Race/Ethnicity, Customized African Heritage / African American	60 Participants n=5 Participants	52 Participants n=7 Participants	57 Participants n=5 Participants	70 Participants n=4 Participants	239 Participants n=21 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	8 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	10 Participants n=4 Participants	38 Participants n=21 Participants

PRIMARY outcome

Timeframe: At Day 42

Population: 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

Outcome measures

Outcome measures
Measure	INV_MMR _L1 Group n=1083 Participants 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.	INV_MMR _L2 Group n=1069 Participants 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.	INV_MMR _L3 Group n=1096 Participants 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.	INV_MMR Group 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.	COM_MMR Group 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.
Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value Anti-measles ≥ 150 mIU/mL	98.2 Percentage of subjects Interval 97.3 to 98.9	98.9 Percentage of subjects Interval 98.0 to 99.4	98.1 Percentage of subjects Interval 97.1 to 98.8	—	—
Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value Anti-measles ≥ 200 mIU/mL	98.1 Percentage of subjects Interval 97.1 to 98.8	98.6 Percentage of subjects Interval 97.7 to 99.2	97.8 Percentage of subjects Interval 96.8 to 98.6	—	—

PRIMARY outcome

Timeframe: At Day 42

Population: 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

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.

Outcome measures

Outcome measures
Measure	INV_MMR _L1 Group n=1083 Participants 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.	INV_MMR _L2 Group n=1069 Participants 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.	INV_MMR _L3 Group n=1096 Participants 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.	INV_MMR Group 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.	COM_MMR Group 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.
Anti-measles Virus Antibody Concentrations	2970.3 mIU/mL Interval 2813.2 to 3136.2	3023.6 mIU/mL Interval 2864.5 to 3191.6	3058.3 mIU/mL Interval 2893.9 to 3232.0	—	—

PRIMARY outcome

Timeframe: At Day 42

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.

Outcome measures

Outcome measures
Measure	INV_MMR _L1 Group n=1062 Participants 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.	INV_MMR _L2 Group n=1047 Participants 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.	INV_MMR _L3 Group n=1078 Participants 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.	INV_MMR Group 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.	COM_MMR Group 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.
Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value Anti-mumps ≥ 5 EU/mL	99.7 Percentage of subjects Interval 99.2 to 99.9	99.3 Percentage of subjects Interval 98.6 to 99.7	99.2 Percentage of subjects Interval 98.4 to 99.6	—	—
Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value Anti-mumps ≥ 10 EU/mL	98.6 Percentage of subjects Interval 97.7 to 99.2	98.6 Percentage of subjects Interval 97.6 to 99.2	98.0 Percentage of subjects Interval 96.9 to 98.7	—	—

PRIMARY outcome

Timeframe: At Day 42

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.

Outcome measures

Outcome measures
Measure	INV_MMR _L1 Group n=1062 Participants 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.	INV_MMR _L2 Group n=1047 Participants 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.	INV_MMR _L3 Group n=1078 Participants 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.	INV_MMR Group 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.	COM_MMR Group 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.
Anti-mumps Virus Antibody Concentration	71.7 EU/mL Interval 68.3 to 75.2	76.9 EU/mL Interval 73.2 to 80.8	69.0 EU/mL Interval 65.5 to 72.7	—	—

PRIMARY outcome

Timeframe: At Day 42

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.

Outcome measures

Outcome measures
Measure	INV_MMR _L1 Group n=1083 Participants 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.	INV_MMR _L2 Group n=1067 Participants 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.	INV_MMR _L3 Group n=1095 Participants 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.	INV_MMR Group 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.	COM_MMR Group 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.
Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value Anti-rubella ≥ 4 IU/mL	99.4 Percentage of subjects Interval 98.8 to 99.8	99.7 Percentage of subjects Interval 99.2 to 99.9	99.4 Percentage of subjects Interval 98.7 to 99.7	—	—
Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value Anti-rubella ≥ 10 IU/mL	97.2 Percentage of subjects Interval 96.1 to 98.1	97.1 Percentage of subjects Interval 95.9 to 98.0	97.7 Percentage of subjects Interval 96.6 to 98.5	—	—

PRIMARY outcome

Timeframe: At Day 42

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.

Outcome measures

Outcome measures
Measure	INV_MMR _L1 Group n=1083 Participants 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.	INV_MMR _L2 Group n=1067 Participants 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.	INV_MMR _L3 Group n=1095 Participants 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.	INV_MMR Group 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.	COM_MMR Group 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.
Anti-rubella Virus Antibody Concentration	57.2 IU/mL Interval 54.4 to 60.1	53.1 IU/mL Interval 50.5 to 55.7	57.0 IU/mL Interval 54.3 to 59.8	—	—

PRIMARY outcome

Timeframe: At Day 42

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.

Outcome measures

Outcome measures
Measure	INV_MMR _L1 Group n=3248 Participants 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.	INV_MMR _L2 Group n=1137 Participants 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.	INV_MMR _L3 Group 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.	INV_MMR Group 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.	COM_MMR Group 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.
Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups Anti-measles ≥ 150 mIU/mL	98.4 Percentage of subjects Interval 97.9 to 98.8	98.1 Percentage of subjects Interval 97.1 to 98.8	—	—	—
Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups Anti-measles ≥ 200 mIU/mL	98.2 Percentage of subjects Interval 97.6 to 98.6	98.0 Percentage of subjects Interval 97.0 to 98.7	—	—	—

PRIMARY outcome

Timeframe: At Day 42

Antibody concentrations were expressed as GMCs in mIU/mL.

Outcome measures

Outcome measures
Measure	INV_MMR _L1 Group n=3248 Participants 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.	INV_MMR _L2 Group n=1137 Participants 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.	INV_MMR _L3 Group 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.	INV_MMR Group 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.	COM_MMR Group 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.
Anti-measles Virus Antibody Concentrations in Pooled MMR Groups	3017.4 mIU/mL Interval 2923.9 to 3113.8	3074.4 mIU/mL Interval 2911.0 to 3246.9	—	—	—

PRIMARY outcome

Timeframe: At Day 42

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.

Outcome measures

Outcome measures
Measure	INV_MMR _L1 Group n=3187 Participants 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.	INV_MMR _L2 Group n=1107 Participants 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.	INV_MMR _L3 Group 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.	INV_MMR Group 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.	COM_MMR Group 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.
Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups Anti-mumps ≥ 5 EU/mL	99.4 Percentage of subjects Interval 99.1 to 99.6	99.3 Percentage of subjects Interval 98.6 to 99.7	—	—	—
Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups Anti-mumps ≥ 10 EU/mL	98.4 Percentage of subjects Interval 97.9 to 98.8	97.6 Percentage of subjects Interval 96.5 to 98.4	—	—	—

PRIMARY outcome

Timeframe: At Day 42

Antibody concentrations were expressed as GMCs in EU/mL.

Outcome measures

Outcome measures
Measure	INV_MMR _L1 Group n=3187 Participants 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.	INV_MMR _L2 Group n=1107 Participants 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.	INV_MMR _L3 Group 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.	INV_MMR Group 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.	COM_MMR Group 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.
Anti-mumps Virus Antibody Concentration in Pooled MMR Groups	72.4 EU/mL Interval 70.4 to 74.5	69.1 EU/mL Interval 65.7 to 72.7	—	—	—

PRIMARY outcome

Timeframe: At Day 42

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.

Outcome measures

Outcome measures
Measure	INV_MMR _L1 Group n=3245 Participants 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.	INV_MMR _L2 Group n=1135 Participants 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.	INV_MMR _L3 Group 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.	INV_MMR Group 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.	COM_MMR Group 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.
Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups Anti-rubella ≥ 4 IU/mL	99.5 Percentage of subjects Interval 99.2 to 99.7	99.6 Percentage of subjects Interval 99.0 to 99.9	—	—	—
Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups Anti-rubella ≥ 10 IU/mL	97.3 Percentage of subjects Interval 96.7 to 97.9	98.5 Percentage of subjects Interval 97.6 to 99.1	—	—	—

PRIMARY outcome

Timeframe: At Day 42

Antibody concentrations were expressed as GMCs in IU/mL.

Outcome measures

Outcome measures
Measure	INV_MMR _L1 Group n=3245 Participants 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.	INV_MMR _L2 Group n=1135 Participants 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.	INV_MMR _L3 Group 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.	INV_MMR Group 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.	COM_MMR Group 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.
Anti-rubella Virus Antibody Concentration in Pooled MMR Groups	55.7 IU/mL Interval 54.2 to 57.3	64.0 IU/mL Interval 61.1 to 67.0	—	—	—

SECONDARY outcome

Timeframe: At Day 42

Population: 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

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.

Outcome measures

Outcome measures
Measure	INV_MMR _L1 Group n=1492 Participants 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.	INV_MMR _L2 Group n=540 Participants 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.	INV_MMR _L3 Group 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.	INV_MMR Group 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.	COM_MMR Group 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.
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 Anti-VZV ≥ 25 mIU/mL	99.7 Percentage of subjects Interval 99.3 to 99.9	99.6 Percentage of subjects Interval 98.7 to 100.0	—	—	—
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 Anti-VZV ≥ 75 mIU/mL	92.2 Percentage of subjects Interval 90.7 to 93.5	90.9 Percentage of subjects Interval 88.2 to 93.2	—	—	—

SECONDARY outcome

Timeframe: At Day 42

Antibody concentrations were expressed as GMCs in mIU/mL.

Outcome measures

Outcome measures
Measure	INV_MMR _L1 Group n=1492 Participants 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.	INV_MMR _L2 Group n=540 Participants 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.	INV_MMR _L3 Group 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.	INV_MMR Group 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.	COM_MMR Group 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.
Anti-VZV Virus Antibody Concentration in US Sub-cohort of Pooled MMR Groups	169.6 mIU/mL Interval 164.3 to 175.0	167.2 mIU/mL Interval 158.2 to 176.7	—	—	—

SECONDARY outcome

Timeframe: At Day 42

Percentage of subjects with an Anti-HAV antibody concentration equal to or above 15 mIU/mL were reported.

Outcome measures

Outcome measures
Measure	INV_MMR _L1 Group n=783 Participants 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.	INV_MMR _L2 Group n=285 Participants 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.	INV_MMR _L3 Group 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.	INV_MMR Group 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.	COM_MMR Group 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.
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	88.9 Percentage of subjects Interval 86.5 to 91.0	87.4 Percentage of subjects Interval 82.9 to 91.0	—	—	—

SECONDARY outcome

Timeframe: At Day 42

Antibody concentrations were expressed as GMCs in mIU/mL.

Outcome measures

Outcome measures
Measure	INV_MMR _L1 Group n=783 Participants 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.	INV_MMR _L2 Group n=285 Participants 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.	INV_MMR _L3 Group 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.	INV_MMR Group 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.	COM_MMR Group 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.
Anti-HAV Antibody Concentrations in US Sub-cohort of Pooled MMR Groups	42.0 mIU/mL Interval 39.3 to 44.8	42.4 mIU/mL Interval 38.1 to 47.2	—	—	—

SECONDARY outcome

Timeframe: At Day 42

Antibody concentrations were expressed as GMCs in microgram/Milliliter (µg/mL).

Outcome measures

Outcome measures
Measure	INV_MMR _L1 Group n=759 Participants 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.	INV_MMR _L2 Group n=266 Participants 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.	INV_MMR _L3 Group 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.	INV_MMR Group 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.	COM_MMR Group 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.
Anti-S.Pneumoniae Antibody Concentration in US Sub-cohort of Pooled MMR Groups anti-PnPS 1 antibody	2.257 µg/mL Interval 2.121 to 2.402	2.425 µg/mL Interval 2.195 to 2.679	—	—	—
Anti-S.Pneumoniae Antibody Concentration in US Sub-cohort of Pooled MMR Groups anti-PnPS 3 antibody	0.506 µg/mL Interval 0.481 to 0.533	0.496 µg/mL Interval 0.454 to 0.542	—	—	—
Anti-S.Pneumoniae Antibody Concentration in US Sub-cohort of Pooled MMR Groups anti-PnPS 4 antibody	1.618 µg/mL Interval 1.518 to 1.725	1.872 µg/mL Interval 1.676 to 2.091	—	—	—
Anti-S.Pneumoniae Antibody Concentration in US Sub-cohort of Pooled MMR Groups anti-PnPS 5 antibody	2.106 µg/mL Interval 1.991 to 2.228	2.280 µg/mL Interval 2.085 to 2.493	—	—	—
Anti-S.Pneumoniae Antibody Concentration in US Sub-cohort of Pooled MMR Groups anti-PnPS 6A antibody	5.840 µg/mL Interval 5.508 to 6.192	5.743 µg/mL Interval 5.233 to 6.304	—	—	—
Anti-S.Pneumoniae Antibody Concentration in US Sub-cohort of Pooled MMR Groups anti-PnPS 6B antibody	5.872 µg/mL Interval 5.504 to 6.265	5.838 µg/mL Interval 5.239 to 6.505	—	—	—
Anti-S.Pneumoniae Antibody Concentration in US Sub-cohort of Pooled MMR Groups anti-PnPS 7F antibody	3.691 µg/mL Interval 3.489 to 3.905	3.814 µg/mL Interval 3.484 to 4.176	—	—	—
Anti-S.Pneumoniae Antibody Concentration in US Sub-cohort of Pooled MMR Groups anti-PnPS 9V antibody	2.318 µg/mL Interval 2.183 to 2.461	2.282 µg/mL Interval 2.065 to 2.521	—	—	—
Anti-S.Pneumoniae Antibody Concentration in US Sub-cohort of Pooled MMR Groups anti-PnPS 14 antibody	6.578 µg/mL Interval 6.155 to 7.029	7.053 µg/mL Interval 6.368 to 7.811	—	—	—
Anti-S.Pneumoniae Antibody Concentration in US Sub-cohort of Pooled MMR Groups anti-PnPS 18C antibody	2.102 µg/mL Interval 1.973 to 2.241	2.217 µg/mL Interval 1.99 to 2.47	—	—	—
Anti-S.Pneumoniae Antibody Concentration in US Sub-cohort of Pooled MMR Groups anti-PnPS 19A antibody	4.731 µg/mL Interval 4.461 to 5.017	4.821 µg/mL Interval 4.372 to 5.317	—	—	—
Anti-S.Pneumoniae Antibody Concentration in US Sub-cohort of Pooled MMR Groups anti-PnPS 19F antibody	4.251 µg/mL Interval 4.013 to 4.504	4.260 µg/mL Interval 3.872 to 4.687	—	—	—
Anti-S.Pneumoniae Antibody Concentration in US Sub-cohort of Pooled MMR Groups anti-PnPS 23F antibody	2.198 µg/mL Interval 2.051 to 2.355	2.291 µg/mL Interval 2.025 to 2.592	—	—	—

SECONDARY outcome

Timeframe: During the 4-days (Days 0-3) post-vaccination period

Population: Total Vaccinated cohort (TVC) included all subjects with at least one vaccine administration of either INV\_MMR or COM\_MMR lots documented

Assessed solicited local AEs were pain, redness and swelling. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.