Trial Outcomes & Findings for Evaluate Vaccine Against Chickenpox and a Combined Vaccine Against 4 Viral Childhood Diseases: Measles, Mumps, Rubella and Chickenpox (NCT NCT00226499)

Last Updated: 2019-09-23

Results Overview

Confirmed varicella case = A case that met the clinical case definition \[an illness with acute onset of diffuse, generalized maculopapulovesicular rash (i.e. spots, papules and/or vesicles) without other apparent cause\] at least in the opinion of the investigator and was confirmed by laboratory test \[Polymerase Chain Reaction (PCR) (+)\] OR a case that met the clinical definition confirmed by the Independent Data Monitoring Committee (IDMC) and was epidemiologically linked \[Epi (+)\] to a valid index case.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

5803 participants

Primary outcome timeframe

From 42 days post dose 2 until the end of Phase A

Results posted on

2019-09-23

Participant Flow

Participant milestones

Participant milestones
Measure	MMRV Group Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).	OKAH Group Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.	MMR Group Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
Overall Study STARTED	2489	2487	827
Overall Study COMPLETED	1415	1415	468
Overall Study NOT COMPLETED	1074	1072	359

Reasons for withdrawal

Reasons for withdrawal
Measure	MMRV Group Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).	OKAH Group Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.	MMR Group Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
Overall Study Adverse Event	10	6	3
Overall Study Others	1064	1066	356

Baseline Characteristics

Evaluate Vaccine Against Chickenpox and a Combined Vaccine Against 4 Viral Childhood Diseases: Measles, Mumps, Rubella and Chickenpox

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MMRV Group n=2489 Participants Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).	OKAH Group n=2487 Participants Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.	MMR Group n=827 Participants Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).	Total n=5803 Participants Total of all reporting groups
Age, Continuous	14.3 Months STANDARD_DEVIATION 2.5 • n=5 Participants	14.2 Months STANDARD_DEVIATION 2.5 • n=7 Participants	14.2 Months STANDARD_DEVIATION 2.5 • n=5 Participants	14.2 Months STANDARD_DEVIATION 2.5 • n=4 Participants
Sex: Female, Male Female	1154 Participants n=5 Participants	1223 Participants n=7 Participants	401 Participants n=5 Participants	2778 Participants n=4 Participants
Sex: Female, Male Male	1335 Participants n=5 Participants	1264 Participants n=7 Participants	426 Participants n=5 Participants	3025 Participants n=4 Participants
Race/Ethnicity, Customized Race · American hispanic	1 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Race/Ethnicity, Customized Race · Arabic/north african	24 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	34 Participants n=4 Participants
Race/Ethnicity, Customized Race · Black	9 Participants n=5 Participants	9 Participants n=7 Participants	1 Participants n=5 Participants	19 Participants n=4 Participants
Race/Ethnicity, Customized Race · East/south east asian	8 Participants n=5 Participants	7 Participants n=7 Participants	1 Participants n=5 Participants	16 Participants n=4 Participants
Race/Ethnicity, Customized Race · Japanese	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Race · Other	13 Participants n=5 Participants	11 Participants n=7 Participants	1 Participants n=5 Participants	25 Participants n=4 Participants
Race/Ethnicity, Customized Race · South asian	3 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants
Race/Ethnicity, Customized Race · White/caucasian	2430 Participants n=5 Participants	2446 Participants n=7 Participants	818 Participants n=5 Participants	5694 Participants n=4 Participants

PRIMARY outcome

Timeframe: From 42 days post dose 2 until the end of Phase A

Population: The analysis was performed on the According-to-Protocol (ATP) Cohort for Efficacy (Phase A), which included all evaluable subjects who had efficacy follow-up starting from 42 days post dose 2.

Outcome measures

Outcome measures
Measure	MMRV Group n=2279 Participants Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).	OKAH Group n=2263 Participants Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.	MMR Group n=743 Participants Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
Phase A: Number of Subjects With Confirmed Varicella Case	37 Participants	243 Participants	201 Participants

SECONDARY outcome

Timeframe: From 42 days post dose 2 until the end of Phase A

Population: The analysis was performed on the ATP Cohort for Efficacy (Phase A), which included all evaluable subjects who had efficacy follow-up starting from 42 days post dose 2.

Confirmed varicella case: A case that met the clinical case definition at least in the opinion of the investigator and was confirmed by laboratory test \[PCR (+)\] OR a case that met the clinical definition confirmed by the IDMC and was epidemiologically linked \[Epi (+)\] to a valid index case. Moderately severe disease: 8-15 points; severe disease: ≥ 16 points (scored by IDMC using the modified Vázquez scale).

Outcome measures

Outcome measures
Measure	MMRV Group n=2279 Participants Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).	OKAH Group n=2263 Participants Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.	MMR Group n=743 Participants Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
Phase A: Number of Subjects With Moderate or Severe Confirmed Varicella Case	2 Participants	37 Participants	117 Participants

SECONDARY outcome

Timeframe: From 42 days post dose 2 until the end of Phase A

Population: The analysis was performed on the ATP Cohort for Efficacy (Phase A), which included all evaluable subjects who had efficacy follow-up starting from 42 days post dose 2.

Probable or confirmed varicella case = A case that met the clinical case definition (as determined by the IDMC) but was not laboratory confirmed \[PCR (-)\] AND was not epidemiologically linked \[Epi (-)\] to another probable or confirmed case.

Outcome measures

Outcome measures
Measure	MMRV Group n=2279 Participants Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).	OKAH Group n=2263 Participants Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.	MMR Group n=743 Participants Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
Phase A: Number of Subjects With Probable or Confirmed Varicella Case	57 Participants	260 Participants	209 Participants

SECONDARY outcome

Timeframe: At Day 0, Day 42, Day 84, Year 1 and Year 2 time points

Population: The analysis was performed on the ATP Cohort for Immunogenicity, which included all evaluable subjects who had pre-vaccination results available for at least one of the vaccine components.

Anti-VZV antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL).

Outcome measures

Outcome measures
Measure	MMRV Group n=2245 Participants Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).	OKAH Group n=2245 Participants Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.	MMR Group n=742 Participants Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
Phase A: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations Anti-VZV, Day 0	12.8 mIU/mL Interval 12.6 to 12.9	12.7 mIU/mL Interval 12.6 to 12.8	12.6 mIU/mL Interval 12.5 to 12.8
Phase A: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations Anti-VZV, Day 42	116.1 mIU/mL Interval 108.3 to 124.5	13.5 mIU/mL Interval 13.0 to 14.1	13.1 mIU/mL Interval 12.5 to 13.9
Phase A: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations Anti-VZV, Day 84	1833.3 mIU/mL Interval 1767.8 to 1901.3	98.1 mIU/mL Interval 94.2 to 102.3	14.7 mIU/mL Interval 13.9 to 15.6
Phase A: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations Anti-VZV, Year 1	365.1 mIU/mL Interval 349.0 to 381.9	145.2 mIU/mL Interval 137.0 to 153.8	20.3 mIU/mL Interval 18.2 to 22.5
Phase A: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations Anti-VZV, Year 2	414.6 mIU/mL Interval 392.1 to 438.5	170.6 mIU/mL Interval 158.1 to 184.1	36.9 mIU/mL Interval 31.6 to 43.1

SECONDARY outcome

Timeframe: At Day 0, Day 42, Day 84, Year 1 and Year 2 time points

Seronegative (S-) = Subjects with antibody concentration less than (\<) 25 mIU/mL prior to vaccination. Seropositive (S+) = Subjects with antibody concentration greater than or equal to (≥) 25 mIU/mL prior to vaccination. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.

Outcome measures

Outcome measures
Measure	MMRV Group n=2245 Participants Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).	OKAH Group n=2245 Participants Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.	MMR Group n=742 Participants Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
Phase A: Number of Subjects With Seroconversion/Seroresponse to VZV Anti-VZV, Day 0	26 Participants	24 Participants	4 Participants
Phase A: Number of Subjects With Seroconversion/Seroresponse to VZV Anti-VZV, Day 42	661 Participants	21 Participants	6 Participants
Phase A: Number of Subjects With Seroconversion/Seroresponse to VZV Anti-VZV, Day 84	2236 Participants	2123 Participants	40 Participants
Phase A: Number of Subjects With Seroconversion/Seroresponse to VZV Anti-VZV, Year 1	2056 Participants	1968 Participants	91 Participants
Phase A: Number of Subjects With Seroconversion/Seroresponse to VZV Anti-VZV, Year 2	1913 Participants	1776 Participants	170 Participants

SECONDARY outcome

Timeframe: At Day 0, Day 42, Day 84, Year 1 and Year 2 time points

Anti-measles antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL).

Outcome measures

Outcome measures
Measure	MMRV Group n=704 Participants Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).	OKAH Group n=713 Participants Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.	MMR Group n=232 Participants Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
Phase A: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations in a Subset of Subjects Anti-measles, Year 1	4993.7 mIU/mL Interval 4714.7 to 5289.2	2856.8 mIU/mL Interval 2658.6 to 3069.7	2885.7 mIU/mL Interval 2520.7 to 3303.5
Phase A: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations in a Subset of Subjects Anti-measles, Day 0	75.7 mIU/mL Interval 74.6 to 76.8	77.9 mIU/mL Interval 75.6 to 80.3	77.9 mIU/mL Interval 73.9 to 82.1
Phase A: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations in a Subset of Subjects Anti-measles, Day 42	3961.0 mIU/mL Interval 3719.7 to 4217.9	2602.7 mIU/mL Interval 2429.6 to 2788.1	2817.4 mIU/mL Interval 2506.3 to 3167.1
Phase A: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations in a Subset of Subjects Anti-measles, Day 84	5809.6 mIU/mL Interval 5544.5 to 6087.3	3438.1 mIU/mL Interval 3210.9 to 3681.5	3695.0 mIU/mL Interval 3318.2 to 4114.6
Phase A: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations in a Subset of Subjects Anti-measles, Year 2	4709.6 mIU/mL Interval 4407.1 to 5033.0	2624.5 mIU/mL Interval 2423.6 to 2842.2	2677.9 mIU/mL Interval 2302.5 to 3114.5

SECONDARY outcome

Timeframe: At Day 0, Day 42, Day 84, Year 1 and Year 2 time points

Seronegative (S-) = Subjects with antibody concentration \< 150 mIU/mL prior to vaccination. Seropositive (S+) = Subjects with antibody concentration ≥ 150 mIU/mL prior to vaccination. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.

Outcome measures

Outcome measures
Measure	MMRV Group n=704 Participants Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).	OKAH Group n=713 Participants Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.	MMR Group n=232 Participants Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
Phase A: Number of Subjects With Seroconversion/Seroresponse to Measles in a Subset of Subjects Anti-measles, Day 0	2 Participants	7 Participants	2 Participants
Phase A: Number of Subjects With Seroconversion/Seroresponse to Measles in a Subset of Subjects Anti-measles, Day 42	676 Participants	682 Participants	225 Participants
Phase A: Number of Subjects With Seroconversion/Seroresponse to Measles in a Subset of Subjects Anti-measles, Day 84	703 Participants	702 Participants	230 Participants
Phase A: Number of Subjects With Seroconversion/Seroresponse to Measles in a Subset of Subjects Anti-measles, Year 1	628 Participants	621 Participants	198 Participants
Phase A: Number of Subjects With Seroconversion/Seroresponse to Measles in a Subset of Subjects Anti-measles, Year 2	584 Participants	583 Participants	183 Participants

SECONDARY outcome

Timeframe: At Day 0, Day 42, Day 84, Year 1 and Year 2 time points

Anti-mumps antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in units per milliliter (U/mL).

Outcome measures

Outcome measures
Measure	MMRV Group n=704 Participants Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).	OKAH Group n=712 Participants Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.	MMR Group n=232 Participants Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
Phase A: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations in a Subset of Subjects Anti-mumps, Day 0	117.5 U/mL Interval 115.4 to 119.7	119.1 U/mL Interval 116.2 to 122.2	118.1 U/mL Interval 114.4 to 122.0
Phase A: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations in a Subset of Subjects Anti-mumps, Day 42	896.6 U/mL Interval 827.0 to 972.0	925.0 U/mL Interval 859.4 to 995.7	945.2 U/mL Interval 839.0 to 1064.9
Phase A: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations in a Subset of Subjects Anti-mumps, Day 84	1496.8 U/mL Interval 1407.7 to 1591.7	759.8 U/mL Interval 705.5 to 818.3	1547.9 U/mL Interval 1408.0 to 1701.6
Phase A: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations in a Subset of Subjects Anti-mumps, Year 1	1008.6 U/mL Interval 928.8 to 1095.2	875.9 U/mL Interval 805.8 to 952.2	1089.6 U/mL Interval 944.0 to 1257.5
Phase A: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations in a Subset of Subjects Anti-mumps, Year 2	1050.6 U/mL Interval 957.5 to 1152.7	882.0 U/mL Interval 805.6 to 965.6	989.4 U/mL Interval 848.3 to 1153.9

SECONDARY outcome

Timeframe: At Day 0, Day 42, Day 84, Year 1 and Year 2 time points

Seronegative (S-) = Subjects with antibody concentration \< 231 U/mL prior to vaccination. Seropositive (S+) = Subjects with antibody concentration ≥ 231 U/mL prior to vaccination. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.

Outcome measures

Outcome measures
Measure	MMRV Group n=704 Participants Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).	OKAH Group n=712 Participants Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.	MMR Group n=232 Participants Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
Phase A: Number of Subjects With Seroconversion/Seroresponse to Mumps in a Subset of Subjects Anti-mumps, Day 0	4 Participants	6 Participants	2 Participants
Phase A: Number of Subjects With Seroconversion/Seroresponse to Mumps in a Subset of Subjects Anti-mumps, Day 42	584 Participants	613 Participants	208 Participants
Phase A: Number of Subjects With Seroconversion/Seroresponse to Mumps in a Subset of Subjects Anti-mumps, Day 84	683 Participants	608 Participants	225 Participants
Phase A: Number of Subjects With Seroconversion/Seroresponse to Mumps in a Subset of Subjects Anti-mumps, Year 1	569 Participants	554 Participants	182 Participants
Phase A: Number of Subjects With Seroconversion/Seroresponse to Mumps in a Subset of Subjects Anti-mumps, Year 2	527 Participants	520 Participants	171 Participants

SECONDARY outcome

Timeframe: At Day 0, Day 42, Day 84, Year 1 and Year 2 time points

Anti-rubella antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in International Units per milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	MMRV Group n=704 Participants Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).	OKAH Group n=713 Participants Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.	MMR Group n=232 Participants Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
Phase A: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations in a Subset of Subjects Anti-rubella, Day 0	2.1 IU/mL Interval 2.0 to 2.1	2.0 IU/mL Interval 2.0 to 2.1	2.1 IU/mL Interval 2.0 to 2.2
Phase A: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations in a Subset of Subjects Anti-rubella, Day 42	57.6 IU/mL Interval 54.2 to 61.2	74.0 IU/mL Interval 69.9 to 78.3	71.0 IU/mL Interval 64.8 to 77.8
Phase A: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations in a Subset of Subjects Anti-rubella, Day 84	104.7 IU/mL Interval 99.8 to 109.8	122.1 IU/mL Interval 116.2 to 128.2	111.9 IU/mL Interval 103.5 to 120.9
Phase A: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations in a Subset of Subjects Anti-rubella, Year 1	88.7 IU/mL Interval 83.9 to 93.8	103.7 IU/mL Interval 97.8 to 110.0	98.0 IU/mL Interval 88.7 to 108.3
Phase A: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations in a Subset of Subjects Anti-rubella, Year 2	71.8 IU/mL Interval 67.5 to 76.4	79.1 IU/mL Interval 74.2 to 84.3	71.8 IU/mL Interval 64.0 to 80.5

SECONDARY outcome

Timeframe: At Day 0, Day 42, Day 84, Year 1 and Year 2 time points

Seronegative (S-) = Subjects with antibody concentration \< 4 IU/mL prior to vaccination. Seropositive (S+) = Subjects with antibody concentration ≥ 4 IU/mL prior to vaccination. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.

Outcome measures

Outcome measures
Measure	MMRV Group n=704 Participants Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).	OKAH Group n=713 Participants Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.	MMR Group n=232 Participants Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
Phase A: Number of Subjects With a Seroconversion/Seroresponse to Rubella in a Subset of Subjects Anti-rubella, Day 0	7 Participants	5 Participants	2 Participants
Phase A: Number of Subjects With a Seroconversion/Seroresponse to Rubella in a Subset of Subjects Anti-rubella, Day 42	688 Participants	693 Participants	230 Participants
Phase A: Number of Subjects With a Seroconversion/Seroresponse to Rubella in a Subset of Subjects Anti-rubella, Day 84	704 Participants	710 Participants	231 Participants
Phase A: Number of Subjects With a Seroconversion/Seroresponse to Rubella in a Subset of Subjects Anti-rubella, Year 1	630 Participants	628 Participants	200 Participants
Phase A: Number of Subjects With a Seroconversion/Seroresponse to Rubella in a Subset of Subjects Anti-rubella, Year 2	589 Participants	590 Participants	186 Participants

SECONDARY outcome

Timeframe: From Day 0 until the end of Phase A (Year 2)

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.

The number of subjects with confirmed cases of herpes zoster is reported.

Outcome measures

Outcome measures
Measure	MMRV Group n=807 Participants Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).	OKAH Group n=812 Participants Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.	MMR Group n=268 Participants Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
Phase A: Number of Subjects With Confirmed Cases of Herpes Zoster	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 43 days (Day 0-42) post-vaccination period following each dose

Population: The analysis was performed on a subset of the Total Vaccinated Cohort. The subset of subjects was identified as 200 subjects from each country. Depending on the country, this subset was stipulated to be either the first 200 subjects enrolled irrespective of the study center or 200 subjects enrolled at selected centers.

All fever = Occurrence of any fever (measured rectally) regardless of its intensity grade or relationship to vaccination. Related = fever (measured rectally) assessed by the investigator to be causally related to the study vaccination. Medical Advice = seek for medical advice.

Outcome measures

Outcome measures
Measure	MMRV Group n=784 Participants Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).	OKAH Group n=795 Participants Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.	MMR Group n=256 Participants Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
Phase A: Number of Subjects Reporting Fever All Fever, Dose 1	503 Participants	439 Participants	132 Participants
Phase A: Number of Subjects Reporting Fever Related Fever, Dose 1	332 Participants	240 Participants	82 Participants
Phase A: Number of Subjects Reporting Fever Related Fever ≥ 38°C, Dose 1	332 Participants	240 Participants	82 Participants
Phase A: Number of Subjects Reporting Fever Related Fever > 38.5°C, Dose 1	222 Participants	147 Participants	46 Participants
Phase A: Number of Subjects Reporting Fever Related Fever > 39°C, Dose 1	141 Participants	90 Participants	29 Participants
Phase A: Number of Subjects Reporting Fever Related Fever > 39.5°C, Dose 1	71 Participants	48 Participants	13 Participants
Phase A: Number of Subjects Reporting Fever Related Fever > 40°C, Dose 1	22 Participants	18 Participants	5 Participants
Phase A: Number of Subjects Reporting Fever Fever ≥ 38°C, Dose 1	503 Participants	439 Participants	132 Participants
Phase A: Number of Subjects Reporting Fever Fever > 38.5°C, Dose 1	359 Participants	297 Participants	84 Participants
Phase A: Number of Subjects Reporting Fever Fever > 39°C, Dose 1	249 Participants	191 Participants	55 Participants
Phase A: Number of Subjects Reporting Fever Fever > 39.5°C, Dose 1	139 Participants	100 Participants	29 Participants
Phase A: Number of Subjects Reporting Fever Fever > 40°C, Dose 1	49 Participants	43 Participants	15 Participants
Phase A: Number of Subjects Reporting Fever Fever Medical Advice, Dose 1	203 Participants	177 Participants	46 Participants
Phase A: Number of Subjects Reporting Fever All Fever, Dose 2	303 Participants	313 Participants	103 Participants
Phase A: Number of Subjects Reporting Fever Related Fever, Dose 2	136 Participants	144 Participants	41 Participants
Phase A: Number of Subjects Reporting Fever Related Fever ≥ 38°C, Dose 2	136 Participants	144 Participants	41 Participants
Phase A: Number of Subjects Reporting Fever Related Fever > 38.5°C, Dose 2	78 Participants	88 Participants	25 Participants
Phase A: Number of Subjects Reporting Fever Related Fever > 39°C, Dose 2	51 Participants	54 Participants	20 Participants
Phase A: Number of Subjects Reporting Fever Related Fever > 39.5°C, Dose 2	25 Participants	32 Participants	11 Participants
Phase A: Number of Subjects Reporting Fever Related Fever > 40°C, Dose 2	9 Participants	9 Participants	3 Participants
Phase A: Number of Subjects Reporting Fever Fever ≥ 38°C, Dose 2	303 Participants	313 Participants	103 Participants
Phase A: Number of Subjects Reporting Fever Fever > 38.5°C, Dose 2	212 Participants	205 Participants	69 Participants
Phase A: Number of Subjects Reporting Fever Fever > 39°C, Dose 2	136 Participants	132 Participants	54 Participants
Phase A: Number of Subjects Reporting Fever Fever > 39.5°C, Dose 2	66 Participants	74 Participants	30 Participants
Phase A: Number of Subjects Reporting Fever Fever > 40°C, Dose 2	20 Participants	25 Participants	8 Participants
Phase A: Number of Subjects Reporting Fever Fever Medical Advice, Dose 2	112 Participants	119 Participants	44 Participants

SECONDARY outcome

Timeframe: Within 15 days (Day 0-14) post-vaccination period following each dose

All fever = Occurrence of any fever (measured rectally) regardless of its intensity grade or relationship to vaccination. Related fever = fever (measured rectally) assessed by the investigator to be causally related to the study vaccination. Medical Advice = seek for medical advice.

Outcome measures

Outcome measures
Measure	MMRV Group n=784 Participants Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).	OKAH Group n=795 Participants Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.	MMR Group n=256 Participants Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
Phase A: Number of Subjects Reporting Fever All Fever, Dose 1	450 Participants	354 Participants	102 Participants
Phase A: Number of Subjects Reporting Fever Related Fever, Dose 1	328 Participants	226 Participants	69 Participants
Phase A: Number of Subjects Reporting Fever Related Fever ≥ 38°C, Dose 1	328 Participants	226 Participants	69 Participants
Phase A: Number of Subjects Reporting Fever Related Fever > 38.5°C, Dose 1	216 Participants	134 Participants	36 Participants
Phase A: Number of Subjects Reporting Fever Related Fever > 39°C, Dose 1	135 Participants	82 Participants	23 Participants
Phase A: Number of Subjects Reporting Fever Related Fever > 39.5°C, Dose 1	67 Participants	42 Participants	10 Participants
Phase A: Number of Subjects Reporting Fever Related Fever > 40°C, Dose 1	19 Participants	15 Participants	4 Participants
Phase A: Number of Subjects Reporting Fever Fever ≥ 38°C, Dose 1	449 Participants	349 Participants	101 Participants
Phase A: Number of Subjects Reporting Fever Fever > 38.5°C, Dose 1	300 Participants	213 Participants	54 Participants
Phase A: Number of Subjects Reporting Fever Fever > 39°C, Dose 1	196 Participants	124 Participants	34 Participants
Phase A: Number of Subjects Reporting Fever Fever > 39.5°C, Dose 1	101 Participants	58 Participants	16 Participants
Phase A: Number of Subjects Reporting Fever Fever > 40°C, Dose 1	30 Participants	21 Participants	6 Participants
Phase A: Number of Subjects Reporting Fever Fever Medical Advice, Dose 1	140 Participants	100 Participants	26 Participants
Phase A: Number of Subjects Reporting Fever All Fever, Dose 2	189 Participants	201 Participants	55 Participants
Phase A: Number of Subjects Reporting Fever Related Fever, Dose 2	118 Participants	125 Participants	32 Participants
Phase A: Number of Subjects Reporting Fever Related Fever ≥ 38°C, Dose 2	118 Participants	125 Participants	32 Participants
Phase A: Number of Subjects Reporting Fever Related Fever > 38.5°C, Dose 2	60 Participants	73 Participants	18 Participants
Phase A: Number of Subjects Reporting Fever Related Fever > 39°C, Dose 2	34 Participants	41 Participants	16 Participants
Phase A: Number of Subjects Reporting Fever Related Fever > 39.5°C, Dose 2	17 Participants	22 Participants	9 Participants
Phase A: Number of Subjects Reporting Fever Related Fever > 40°C, Dose 2	6 Participants	5 Participants	3 Participants
Phase A: Number of Subjects Reporting Fever Fever ≥ 38°C, Dose 2	184 Participants	200 Participants	51 Participants
Phase A: Number of Subjects Reporting Fever Fever > 38.5°C, Dose 2	101 Participants	110 Participants	30 Participants
Phase A: Number of Subjects Reporting Fever Fever > 39°C, Dose 2	62 Participants	65 Participants	24 Participants
Phase A: Number of Subjects Reporting Fever Fever > 39.5°C, Dose 2	28 Participants	35 Participants	14 Participants
Phase A: Number of Subjects Reporting Fever Fever > 40°C, Dose 2	8 Participants	11 Participants	4 Participants
Phase A: Number of Subjects Reporting Fever Fever Medical Advice, Dose 2	43 Participants	48 Participants	13 Participants

SECONDARY outcome

Timeframe: 4 days post-vaccination period following each dose

Solicited local symptoms assessed were pain, redness and swelling. Any solicited local symptom = Occurrence of any local symptom regardless of their intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling = greater than (\>) 20 mm.

Outcome measures

Outcome measures
Measure	MMRV Group n=782 Participants Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).	OKAH Group n=796 Participants Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.	MMR Group n=256 Participants Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
Phase A: Number of Subjects Reporting Solicited Local Symptoms Grade 3 Redness, Dose 2	26 Participants	3 Participants	0 Participants
Phase A: Number of Subjects Reporting Solicited Local Symptoms Any Swelling, Dose 2	72 Participants	31 Participants	3 Participants
Phase A: Number of Subjects Reporting Solicited Local Symptoms Grade 3 Swelling, Dose 2	4 Participants	0 Participants	0 Participants
Phase A: Number of Subjects Reporting Solicited Local Symptoms Any Pain, Dose 1	74 Participants	83 Participants	20 Participants
Phase A: Number of Subjects Reporting Solicited Local Symptoms Grade 3 Pain, Dose 1	1 Participants	2 Participants	0 Participants
Phase A: Number of Subjects Reporting Solicited Local Symptoms Any Redness, Dose 1	137 Participants	154 Participants	36 Participants
Phase A: Number of Subjects Reporting Solicited Local Symptoms Grade 3 Redness, Dose 1	3 Participants	3 Participants	0 Participants
Phase A: Number of Subjects Reporting Solicited Local Symptoms Any Swelling, Dose 1	38 Participants	37 Participants	6 Participants
Phase A: Number of Subjects Reporting Solicited Local Symptoms Grade 3 Swelling, Dose 1	3 Participants	0 Participants	0 Participants
Phase A: Number of Subjects Reporting Solicited Local Symptoms Any Pain, Dose 2	91 Participants	63 Participants	16 Participants
Phase A: Number of Subjects Reporting Solicited Local Symptoms Grade 3 Pain, Dose 2	0 Participants	1 Participants	1 Participants
Phase A: Number of Subjects Reporting Solicited Local Symptoms Any Redness, Dose 2	188 Participants	106 Participants	23 Participants

SECONDARY outcome

Timeframe: Within 43 days (Day 0-42) post-vaccination period following each dose

Any = Occurrence of meningism regardless of its intensity grade. Grade 3 meningism = Prevented normal, everyday activities. Related = Assessed by the investigator to be causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	MMRV Group n=784 Participants Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).	OKAH Group n=795 Participants Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.	MMR Group n=256 Participants Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
Phase A: Number of Subjects Reporting Meningism Any Meningism, Dose 1	1 Participants	0 Participants	0 Participants
Phase A: Number of Subjects Reporting Meningism Grade 3 Meningism, Dose 1	1 Participants	0 Participants	0 Participants
Phase A: Number of Subjects Reporting Meningism Related Meningism, Dose 1	1 Participants	0 Participants	0 Participants
Phase A: Number of Subjects Reporting Meningism Any Meningism, Dose 2	0 Participants	1 Participants	0 Participants
Phase A: Number of Subjects Reporting Meningism Grade 3 Meningism, Dose 2	0 Participants	0 Participants	0 Participants
Phase A: Number of Subjects Reporting Meningism Related Meningism, Dose 2	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 43 days (Day 0-42) post-vaccination period following each dose

Any = Occurrence of parotitis regardless of its intensity grade. Grade 3 parotitis = Swelling with accompanying general symptoms. Related = Assessed by the investigator to be causally related to the study.

Outcome measures

Outcome measures
Measure	MMRV Group n=784 Participants Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).	OKAH Group n=795 Participants Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.	MMR Group n=256 Participants Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
Phase A: Number of Subjects Reporting Parotitis Any Parotitis, Dose 1	4 Participants	5 Participants	1 Participants
Phase A: Number of Subjects Reporting Parotitis Grade 3 Parotitis, Dose 1	2 Participants	1 Participants	0 Participants
Phase A: Number of Subjects Reporting Parotitis Related Parotitis, Dose 1	3 Participants	3 Participants	0 Participants
Phase A: Number of Subjects Reporting Parotitis Any Parotitis, Dose 2	0 Participants	2 Participants	0 Participants
Phase A: Number of Subjects Reporting Parotitis Grade 3 Parotitis, Dose 2	0 Participants	1 Participants	0 Participants
Phase A: Number of Subjects Reporting Parotitis Related Parotitis, Dose 2	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 43 days (Day 0-42) post-vaccination period following each dose

Any = Occurrence of rash regardless of its intensity grade. Grade 3 rash = 101-500 lesions. Grade 4 rash = \> 500 lesions. Related rash = Assessed by the investigator to be causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	MMRV Group n=784 Participants Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).	OKAH Group n=795 Participants Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.	MMR Group n=256 Participants Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
Phase A: Number of Subjects Reporting Rash Generalized Grade 3/4, Dose 2	5 Participants	6 Participants	1 Participants
Phase A: Number of Subjects Reporting Rash Any Localized or Generalized,Dose 1	82 Participants	84 Participants	30 Participants
Phase A: Number of Subjects Reporting Rash Any Localized, Dose 1	14 Participants	15 Participants	6 Participants
Phase A: Number of Subjects Reporting Rash Localized Admin. site, Dose 1	0 Participants	1 Participants	0 Participants
Phase A: Number of Subjects Reporting Rash Localized Other site, Dose 1	14 Participants	14 Participants	6 Participants
Phase A: Number of Subjects Reporting Rash Any Generalized, Dose 1	68 Participants	69 Participants	24 Participants
Phase A: Number of Subjects Reporting Rash Generalized With fever, Dose 1	41 Participants	41 Participants	14 Participants
Phase A: Number of Subjects Reporting Rash Generalized Measles/Rubella, Dose 1	30 Participants	24 Participants	9 Participants
Phase A: Number of Subjects Reporting Rash Generalized Grade 3/4, Dose 1	9 Participants	12 Participants	7 Participants
Phase A: Number of Subjects Reporting Rash Generalized Grade 4, Dose 1	2 Participants	2 Participants	4 Participants
Phase A: Number of Subjects Reporting Rash Generalized Related, Dose 1	27 Participants	32 Participants	13 Participants
Phase A: Number of Subjects Reporting Rash Any Localized or Generalized,Dose 2	42 Participants	36 Participants	9 Participants
Phase A: Number of Subjects Reporting Rash Any Localized, Dose 2	5 Participants	12 Participants	4 Participants
Phase A: Number of Subjects Reporting Rash Localized Admin. site, Dose 2	0 Participants	2 Participants	0 Participants
Phase A: Number of Subjects Reporting Rash Localized Other site, Dose 2	5 Participants	10 Participants	4 Participants
Phase A: Number of Subjects Reporting Rash Any Generalized, Dose 2	37 Participants	24 Participants	5 Participants
Phase A: Number of Subjects Reporting Rash Generalized With fever, Dose 2	9 Participants	11 Participants	4 Participants
Phase A: Number of Subjects Reporting Rash Generalized Measles/Rubella, Dose 2	8 Participants	4 Participants	0 Participants
Phase A: Number of Subjects Reporting Rash Generalized Grade 4, Dose 2	2 Participants	1 Participants	0 Participants
Phase A: Number of Subjects Reporting Rash Generalized Related, Dose 2	12 Participants	6 Participants	1 Participants

SECONDARY outcome

Timeframe: Within 43 days (Day 0-42) post-vaccination period following each dose

Any = Occurrence of meningism including febrile convulsions regardless of intensity grade.

Outcome measures

Outcome measures
Measure	MMRV Group n=784 Participants Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).	OKAH Group n=795 Participants Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.	MMR Group n=256 Participants Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
Phase A: Number of Subjects With Suspected Sign of Meningism Including Febrile Convulsions Meningism including febrile convulsions, Dose 1	1 Participants	0 Participants	0 Participants
Phase A: Number of Subjects With Suspected Sign of Meningism Including Febrile Convulsions Meningism including febrile convulsions, Dose 2	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 43 days (Day 0-42) post-vaccination period following each dose

Unsolicited AE assessed included any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.

Outcome measures

Outcome measures
Measure	MMRV Group n=807 Participants Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).	OKAH Group n=812 Participants Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.	MMR Group n=268 Participants Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
Phase A: Number of Subjects Reporting Unsolicited Adverse Events (AEs) Any AE(s), Dose 2	239 Participants	258 Participants	90 Participants
Phase A: Number of Subjects Reporting Unsolicited Adverse Events (AEs) Any AE(s), Dose 1	301 Participants	303 Participants	82 Participants

SECONDARY outcome

Timeframe: From Day 0 until the end of Phase A (Year 2)

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalisation or prolongation of hospitalisation or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination.

Outcome measures

Outcome measures
Measure	MMRV Group n=2489 Participants Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).	OKAH Group n=2487 Participants Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.	MMR Group n=827 Participants Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
Phase A: Number of Subjects Reporting Serious Adverse Events (SAEs)	473 Participants	480 Participants	148 Participants

SECONDARY outcome

Timeframe: During Phase A (from Day 0 up to Year 2)

Population: The analysis was performed on the ATP Cohort for Efficacy (Phase A), which included all evaluable subjects who had efficacy follow-up starting from 42 days post dose 2.

Parameters assessed: 1. Number of hours lost from work by parents/guardians as a result of taking care of their child due to varicella. 2. Number of hours the child lost attendance in: day care/childminder, school, or in any extra-curricular activities (e.g. sports or recreation or any type of organised leisure activities) due to varicella. 3. Number of hours spent by a nurse, a babysitter or any type of existing paid caregiver to look after the child (if applicable).

Outcome measures

Outcome measures
Measure	MMRV Group n=37 Participants Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).	OKAH Group n=246 Participants Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.	MMR Group n=201 Participants Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
Phase A: Health Economics Analysis of Factors Leading to Indirect Costs Due to Varicella Illness Time lost from work [hours]	31.5 Hours Standard Deviation 22.9	40.5 Hours Standard Deviation 31.4	48.1 Hours Standard Deviation 35.3
Phase A: Health Economics Analysis of Factors Leading to Indirect Costs Due to Varicella Illness Time lost for subjects [hours]	66.4 Hours Standard Deviation 86.0	49.5 Hours Standard Deviation 31.9	54.5 Hours Standard Deviation 36.4
Phase A: Health Economics Analysis of Factors Leading to Indirect Costs Due to Varicella Illness Time of requested assistance [hours]	34.0 Hours Standard Deviation 31.1	35.2 Hours Standard Deviation 51.6	35.4 Hours Standard Deviation 31.3

SECONDARY outcome

Timeframe: From the beginning of Phase B (Year 2) up to study end (Year 10)

Population: The analysis was performed on the ATP Cohort for Efficacy (Phase B), which included all evaluable subjects who had efficacy follow-up from the period when Phase A was completed.

Confirmed varicella case = A case that met the clinical case definition at least in the opinion of the investigator and was confirmed by laboratory test \[PCR (+)\] OR a case that met the clinical definition confirmed by the IDMC and was epidemiologically linked \[Epi (+)\] to a valid index case.

Outcome measures

Outcome measures
Measure	MMRV Group n=1800 Participants Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).	OKAH Group n=1591 Participants Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.	MMR Group n=396 Participants Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
Phase B: Number of Subjects With Confirmed Varicella Case	38 Participants	225 Participants	149 Participants

SECONDARY outcome

Timeframe: From the beginning of Phase B (Year 2) up to study end (Year 10)

Population: The analysis was performed on the ATP Cohort for Efficacy (Phase B), which included all evaluable subjects who had efficacy follow-up from the period when Phase A was completed.

Outcome measures

Outcome measures
Measure	MMRV Group n=2279 Participants Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).	OKAH Group n=2266 Participants Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.	MMR Group n=744 Participants Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
Phase B: Number of Subjects With Moderate or Severe Confirmed Varicella Case	6 Participants	67 Participants	176 Participants

SECONDARY outcome

Timeframe: From the beginning of Phase B (Year 2) up to study end (Year 10)

Population: The analysis was performed on the ATP Cohort for Efficacy (Phase B), which included all evaluable subjects who had efficacy follow-up from the period when Phase A was completed.

Probable or confirmed varicella = A case that met the clinical case definition (as determined by the IDMC) but was not laboratory confirmed \[PCR (-)\] AND was not epidemiologically linked \[Epi (-)\] to another probable or confirmed case.

Outcome measures

Outcome measures
Measure	MMRV Group n=1800 Participants Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).	OKAH Group n=1591 Participants Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.	MMR Group n=396 Participants Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
Phase B: Number of Subjects With Probable or Confirmed Varicella Case	49 Participants	237 Participants	152 Participants

SECONDARY outcome

Timeframe: From the beginning of Phase B (Year 2) up to study end (Year 10)

Population: The analysis was performed on the ATP Cohort for Efficacy (Phase B), which included all evaluable subjects who had efficacy follow-up from the period when Phase A was completed.

Varicella cases were characterized by type, number and character of lesions, duration of rash, incidence of fever, systemic signs, the assessment by investigator, complications, treatment, outcome and intensity of severity.