Trial Outcomes & Findings for Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Subjects Four to Six Years of Age (NCT NCT01621802)

Last Updated: 2019-11-25

Results Overview

Seroresponse was defined as post-vaccination anti-measles virus antibody concentration equal to or above (≥) 200 milli-international Units per milliliter (mIU/mL). Analysis was done in sub-cohorts 1 and 2 only.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

4011 participants

Primary outcome timeframe

42 days post vaccination (At Day 42)

Results posted on

2019-11-25

Participant Flow

Subjects were enrolled in 3 sub-cohorts. Sub-cohort 1: Inv\_MMR\_CO and Com\_MMR\_CO (Lot 1 or Lot 2), Sub-cohort 2: Inv\_MMR\_I and Com\_MMR\_I (Lot 1 or Lot 2) and Sub-cohort 3: Inv\_MMR\_S and Com\_MMR\_S (Lot 1 or Lot 2).

4011 subjects were enrolled in the study with 4007 eligible subjects receiving a study vaccination.

Participant milestones

Participant milestones
Measure	Inv_MMR_CO Group Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Com_MMR_CO Group Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Inv_MMR_I Group Subjects received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_I Group Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).	Inv_MMR_S Group Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_S Group Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Overall Study STARTED	802	298	796	303	1319	489
Overall Study COMPLETED	755	275	763	292	1284	477
Overall Study NOT COMPLETED	47	23	33	11	35	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Inv_MMR_CO Group Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Com_MMR_CO Group Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Inv_MMR_I Group Subjects received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_I Group Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).	Inv_MMR_S Group Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_S Group Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Overall Study Protocol Violation	0	0	0	0	0	1
Overall Study Withdrawal by Subject	8	4	4	2	2	0
Overall Study Migrated/moved from study area	0	0	2	0	1	0
Overall Study Others	3	3	3	2	1	0
Overall Study Lost to Follow-up	36	16	24	7	31	11

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Inv_MMR_CO Group n=802 Participants Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Com_MMR_CO Group n=298 Participants Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Inv_MMR_I Group n=796 Participants Subjects received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_I Group n=303 Participants Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).	Inv_MMR_S Group n=1319 Participants Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_S Group n=489 Participants Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).	Total n=4007 Participants Total of all reporting groups
Age, Continuous	4.1 Years STANDARD_DEVIATION 0.3 • n=5 Participants	4.1 Years STANDARD_DEVIATION 0.3 • n=7 Participants	4.4 Years STANDARD_DEVIATION 0.6 • n=5 Participants	4.3 Years STANDARD_DEVIATION 0.6 • n=4 Participants	4.4 Years STANDARD_DEVIATION 0.6 • n=21 Participants	4.4 Years STANDARD_DEVIATION 0.6 • n=8 Participants	4.3 Years STANDARD_DEVIATION 0.6 • n=8 Participants
Sex: Female, Male Female	398 Participants n=5 Participants	134 Participants n=7 Participants	361 Participants n=5 Participants	153 Participants n=4 Participants	632 Participants n=21 Participants	225 Participants n=8 Participants	1903 Participants n=8 Participants
Sex: Female, Male Male	404 Participants n=5 Participants	164 Participants n=7 Participants	435 Participants n=5 Participants	150 Participants n=4 Participants	687 Participants n=21 Participants	264 Participants n=8 Participants	2104 Participants n=8 Participants
Race/Ethnicity, Customized Race/Ethnicity · African Heritage / African American	96 Participants n=5 Participants	39 Participants n=7 Participants	48 Participants n=5 Participants	19 Participants n=4 Participants	94 Participants n=21 Participants	32 Participants n=8 Participants	328 Participants n=8 Participants
Race/Ethnicity, Customized Race/Ethnicity · American Indian or Alaskan Native	130 Participants n=5 Participants	38 Participants n=7 Participants	15 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	0 Participants n=8 Participants	190 Participants n=8 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian - Central/South Asian Heritage	12 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	1 Participants n=4 Participants	8 Participants n=21 Participants	0 Participants n=8 Participants	33 Participants n=8 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian - East Asian Heritage	28 Participants n=5 Participants	6 Participants n=7 Participants	384 Participants n=5 Participants	146 Participants n=4 Participants	565 Participants n=21 Participants	209 Participants n=8 Participants	1338 Participants n=8 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian - Japanese Heritage	3 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	5 Participants n=8 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian - South East Asian Heritage	49 Participants n=5 Participants	25 Participants n=7 Participants	11 Participants n=5 Participants	4 Participants n=4 Participants	16 Participants n=21 Participants	8 Participants n=8 Participants	113 Participants n=8 Participants
Race/Ethnicity, Customized Race/Ethnicity · Native Hawaiian or Other Pacific Islander	4 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants	0 Participants n=8 Participants	11 Participants n=8 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other	112 Participants n=5 Participants	45 Participants n=7 Participants	35 Participants n=5 Participants	9 Participants n=4 Participants	52 Participants n=21 Participants	22 Participants n=8 Participants	275 Participants n=8 Participants
Race/Ethnicity, Customized Race/Ethnicity · White - Arabic / North African Heritage	5 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	15 Participants n=8 Participants
Race/Ethnicity, Customized Race/Ethnicity · White - Caucasian / European Heritage	363 Participants n=5 Participants	135 Participants n=7 Participants	291 Participants n=5 Participants	117 Participants n=4 Participants	575 Participants n=21 Participants	218 Participants n=8 Participants	1699 Participants n=8 Participants

PRIMARY outcome

Timeframe: 42 days post vaccination (At Day 42)

Population: This analysis was performed on According to Protocol (ATP) cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for measles vaccine component, did not meet any elimination criteria up to Visit 2 blood sample \& complied with protocol procedures.

Outcome measures

Outcome measures
Measure	Inv_MMR_CO Group n=697 Participants Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Com_MMR_CO Group n=249 Participants Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Inv_MMR_I Group n=736 Participants Subjects received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_I Group n=283 Participants Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).	Inv_MMR_S Group Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_S Group Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value	697 Participants	249 Participants	736 Participants	281 Participants	—	—

PRIMARY outcome

Timeframe: 42 days post vaccination (At Day 42)

Population: This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for mumps vaccine component, did not meet any elimination criteria up to Visit 2 blood sample \& complied with protocol procedures.

Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 ELISA Units per milliliter (EU/mL). Analysis was done in sub-cohorts 1 and 2 only.

Outcome measures

Outcome measures
Measure	Inv_MMR_CO Group n=698 Participants Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Com_MMR_CO Group n=250 Participants Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Inv_MMR_I Group n=736 Participants Subjects received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_I Group n=283 Participants Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).	Inv_MMR_S Group Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_S Group Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Number of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value	698 Participants	250 Participants	736 Participants	283 Participants	—	—

PRIMARY outcome

Timeframe: 42 days post vaccination (At Day 42)

Population: This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for rubella vaccine component, did not meet any elimination criteria up to Visit 2 blood sample \& complied with protocol procedures.

Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 International Units per milliliter (IU/mL). Analysis was done in sub-cohorts 1 and 2 only.

Outcome measures

Outcome measures
Measure	Inv_MMR_CO Group n=697 Participants Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Com_MMR_CO Group n=249 Participants Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Inv_MMR_I Group n=736 Participants Subjects received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_I Group n=283 Participants Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).	Inv_MMR_S Group Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_S Group Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Number of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value	696 Participants	249 Participants	736 Participants	283 Participants	—	—

PRIMARY outcome

Timeframe: 42 days after vaccination (At Day 42)

Population: This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for measles vaccine component, did not meet any elimination criteria up to Visit 2 blood sample \& complied with protocol procedures.

Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. Analysis was done in sub-cohorts 1 and 2 only.

Outcome measures

Outcome measures
Measure	Inv_MMR_CO Group n=697 Participants Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Com_MMR_CO Group n=249 Participants Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Inv_MMR_I Group n=736 Participants Subjects received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_I Group n=283 Participants Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).	Inv_MMR_S Group Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_S Group Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Evaluation of Immunogenicity in Terms of Anti-measles Virus Antibody Concentrations	4335.0 mIU/mL Interval 4089.7 to 4594.9	4215.6 mIU/mL Interval 3806.7 to 4668.4	3646.6 mIU/mL Interval 3453.5 to 3850.4	3503.9 mIU/mL Interval 3174.6 to 3867.4	—	—

PRIMARY outcome

Timeframe: 42 days post vaccination (At Day 42)

Antibody concentrations were expressed as GMCs in EU/mL. Analysis was done in sub-cohorts 1 and 2 only.

Outcome measures

Outcome measures
Measure	Inv_MMR_CO Group n=698 Participants Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Com_MMR_CO Group n=250 Participants Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Inv_MMR_I Group n=736 Participants Subjects received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_I Group n=283 Participants Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).	Inv_MMR_S Group Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_S Group Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Evaluation of Immunogenicity in Terms of Anti-mumps Virus Antibody Concentrations	170.5 EU/mL Interval 161.6 to 179.9	190.1 EU/mL Interval 174.7 to 206.8	167.2 EU/mL Interval 158.6 to 176.3	176.2 EU/mL Interval 161.5 to 192.2	—	—

PRIMARY outcome

Timeframe: 42 days post vaccination (At Day 42)

Antibody concentrations were expressed as GMCs in IU/mL. Analysis was done in sub-cohorts 1 and 2 only.

Outcome measures

Outcome measures
Measure	Inv_MMR_CO Group n=697 Participants Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Com_MMR_CO Group n=249 Participants Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Inv_MMR_I Group n=736 Participants Subjects received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_I Group n=283 Participants Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).	Inv_MMR_S Group Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_S Group Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Evaluation of Immunogenicity in Terms of Anti-rubella Virus Antibody Concentrations	96.4 IU/mL Interval 92.6 to 100.4	96.0 IU/mL Interval 89.5 to 103.0	98.9 IU/mL Interval 95.3 to 102.8	98.7 IU/mL Interval 93.2 to 104.5	—	—

SECONDARY outcome

Timeframe: 42 days post vaccination (At Day 42)

Population: This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample \& complied with protocol procedures.

Seroresponse was defined as post-vaccination anti-VZV antibody concentration ≥ 75 mIU/mL. Analysis was done in sub-cohort 1 only.

Outcome measures

Outcome measures
Measure	Inv_MMR_CO Group n=695 Participants Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Com_MMR_CO Group n=247 Participants Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Inv_MMR_I Group Subjects received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_I Group Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).	Inv_MMR_S Group Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_S Group Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Number of Subjects With Anti-varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off-value	693 Participants	247 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 42 days post vaccination (At Day 42)

Antibody concentrations were expressed as GMCs in mIU/mL. Analysis was done in sub-cohort 1 only.

Outcome measures

Outcome measures
Measure	Inv_MMR_CO Group n=695 Participants Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Com_MMR_CO Group n=247 Participants Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Inv_MMR_I Group Subjects received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_I Group Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).	Inv_MMR_S Group Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_S Group Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Evaluation of Immunogenicity in Terms of Anti-VZV Antibody Concentrations	887.7 mIU/mL Interval 834.3 to 944.4	820.4 mIU/mL Interval 749.3 to 898.3	—	—	—	—

SECONDARY outcome

Timeframe: 42 days post vaccination (At Day 42)

Booster response was defined as: For subjects with pre-vaccination antibody concentration less than (\<) 0.1 IU/mL, antibody concentration ≥ 0.4 IU/ml at Day 42. For subjects with pre-vaccination antibody concentration ≥ 0.1 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration. Analysis was done in sub-cohort 1 only.

Outcome measures

Outcome measures
Measure	Inv_MMR_CO Group n=661 Participants Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Com_MMR_CO Group n=234 Participants Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Inv_MMR_I Group Subjects received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_I Group Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).	Inv_MMR_S Group Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_S Group Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Number of Subjects With Antibody Booster Response to Diphtheria Toxin (Anti-D) and Tetanus Toxin (Anti-T) Anti-D	657 Participants	233 Participants	—	—	—	—
Number of Subjects With Antibody Booster Response to Diphtheria Toxin (Anti-D) and Tetanus Toxin (Anti-T) Anti-T	621 Participants	224 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 42 days post vaccination (At Day 42)

Booster response was defined as: For initially seronegative subjects, antibody concentration ≥ 10.772 IU/mL at Day 42. For initially seropositive subjects with pre-vaccination antibody concentration \< 10.772 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration. For initially seropositive subjects with pre-vaccination antibody concentration ≥ 10.772 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration. Analysis was done in sub-cohort 1 only.

Outcome measures

Outcome measures
Measure	Inv_MMR_CO Group n=659 Participants Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Com_MMR_CO Group n=233 Participants Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Inv_MMR_I Group Subjects received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_I Group Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).	Inv_MMR_S Group Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_S Group Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Number of Subjects With Antibody Booster Response to Pertussis Toxin (PT)	643 Participants	225 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 42 days post vaccination (At Day 42)

Booster response was defined as: For initially seronegative subjects, antibody concentration ≥ 8.184 IU/ml at Day 42. For initially seropositive subjects with pre-vaccination antibody concentration \< 8.184 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration. For initially seropositive subjects with pre-vaccination antibody concentration ≥ 8.184 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration. Analysis was done in sub-cohort 1 only.

Outcome measures

Outcome measures
Measure	Inv_MMR_CO Group n=659 Participants Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Com_MMR_CO Group n=234 Participants Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Inv_MMR_I Group Subjects received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_I Group Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).	Inv_MMR_S Group Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_S Group Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Number of Subjects With Antibody Booster Response to Filamentous Hemagglutinin (FHA)	620 Participants	221 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 42 days post vaccination (At Day 42)

Booster response was defined as: For initially seronegative subjects, antibody concentration ≥ 8.748 IU/mL at Day 42. For initially seropositive subjects with pre-vaccination antibody concentration \< 8.748 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration. For initially seropositive subjects with pre-vaccination antibody concentration ≥ 8.748 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration. Analysis was done in sub-cohort 1 only.

Outcome measures

Outcome measures
Measure	Inv_MMR_CO Group n=660 Participants Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Com_MMR_CO Group n=234 Participants Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Inv_MMR_I Group Subjects received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_I Group Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).	Inv_MMR_S Group Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_S Group Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Number of Subjects With Antibody Booster Response to Pertactin (PRN)	657 Participants	233 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 42 days post vaccination (At Day 42)

Antibody concentrations were expressed as GMCs in IU/mL. Analysis was done in sub-cohort 1 only.

Outcome measures

Outcome measures
Measure	Inv_MMR_CO Group n=684 Participants Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Com_MMR_CO Group n=243 Participants Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Inv_MMR_I Group Subjects received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_I Group Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).	Inv_MMR_S Group Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_S Group Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Evaluation of Immunogenicity in Terms of Anti-D and Anti-T Antibody Concentrations Anti-D	17.2 IU/mL Interval 16.2 to 18.1	17.8 IU/mL Interval 16.1 to 19.6	—	—	—	—
Evaluation of Immunogenicity in Terms of Anti-D and Anti-T Antibody Concentrations Anti-T	7.4 IU/mL Interval 6.9 to 7.8	8.4 IU/mL Interval 7.6 to 9.3	—	—	—	—

SECONDARY outcome

Timeframe: 42 days post vaccination (At Day 42)

Antibody concentrations were expressed as GMCs in EU/mL. Analysis was done in sub-cohort 1 only.

Outcome measures

Outcome measures
Measure	Inv_MMR_CO Group n=684 Participants Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Com_MMR_CO Group n=243 Participants Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Inv_MMR_I Group Subjects received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_I Group Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).	Inv_MMR_S Group Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_S Group Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Evaluation of Immunogenicity in Terms of Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PT	76.6 EU/mL Interval 71.6 to 82.0	73.9 EU/mL Interval 66.2 to 82.4	—	—	—	—
Evaluation of Immunogenicity in Terms of Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-FHA	316.2 EU/mL Interval 299.4 to 334.0	319.3 EU/mL Interval 293.1 to 347.9	—	—	—	—
Evaluation of Immunogenicity in Terms of Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PRN	402.2 EU/mL Interval 370.4 to 436.8	427.3 EU/mL Interval 377.6 to 483.4	—	—	—	—

SECONDARY outcome

Timeframe: 42 days post vaccination (At Day 42)

Analysis was done in sub-cohort 1 only.

Outcome measures

Outcome measures
Measure	Inv_MMR_CO Group n=684 Participants Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Com_MMR_CO Group n=243 Participants Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Inv_MMR_I Group Subjects received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_I Group Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).	Inv_MMR_S Group Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_S Group Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL Anti-T	684 Participants	243 Participants	—	—	—	—
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL Anti-D	684 Participants	243 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 42 days post vaccination (At Day 42)

Analysis was done in sub-cohort 1 only.

Outcome measures

Outcome measures
Measure	Inv_MMR_CO Group n=684 Participants Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Com_MMR_CO Group n=243 Participants Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Inv_MMR_I Group Subjects received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_I Group Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).	Inv_MMR_S Group Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_S Group Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 1.0 IU/mL Anti-D	683 Participants	242 Participants	—	—	—	—
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 1.0 IU/mL Anti-T	678 Participants	243 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 42 days post vaccination (At Day 42)

Antibody titers were expressed as Geometric Mean Titers (GMTs) in ED50. Analysis was done in sub-cohort 1 only.

Outcome measures

Outcome measures
Measure	Inv_MMR_CO Group n=669 Participants Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Com_MMR_CO Group n=238 Participants Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Inv_MMR_I Group Subjects received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_I Group Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).	Inv_MMR_S Group Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_S Group Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Evaluation of Immunogenicity in Terms of Anti-polio Virus Types 1, 2 and 3 Antibody Titers Anti-Polio 1	1618.7 ED50 Interval 1499.8 to 1747.0	1587.3 ED50 Interval 1387.3 to 1816.1	—	—	—	—
Evaluation of Immunogenicity in Terms of Anti-polio Virus Types 1, 2 and 3 Antibody Titers Anti-Polio 2	2026.4 ED50 Interval 1881.2 to 2182.7	2206.1 ED50 Interval 1955.2 to 2489.3	—	—	—	—
Evaluation of Immunogenicity in Terms of Anti-polio Virus Types 1, 2 and 3 Antibody Titers Anti-Polio 3	2753.5 ED50 Interval 2512.4 to 3017.6	3040.6 ED50 Interval 2613.0 to 3538.1	—	—	—	—

SECONDARY outcome

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

Population: This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. Analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e., symptom screen/sheet completed).

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling = greater than 50 millimeters (m m ) i.e . \> 50mm.

Outcome measures

Outcome measures
Measure	Inv_MMR_CO Group n=727 Participants Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Com_MMR_CO Group n=267 Participants Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Inv_MMR_I Group n=766 Participants Subjects received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_I Group n=289 Participants Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).	Inv_MMR_S Group n=1289 Participants Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_S Group n=480 Participants Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Number of Subjects With Solicited Local Symptoms Grade 3 Pain	22 Participants	4 Participants	6 Participants	2 Participants	5 Participants	2 Participants
Number of Subjects With Solicited Local Symptoms Any Pain	295 Participants	109 Participants	152 Participants	64 Participants	278 Participants	123 Participants
Number of Subjects With Solicited Local Symptoms Any Redness	157 Participants	69 Participants	146 Participants	53 Participants	242 Participants	90 Participants
Number of Subjects With Solicited Local Symptoms Grade 3 Redness	9 Participants	4 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms Any Swelling	82 Participants	28 Participants	64 Participants	23 Participants	108 Participants	42 Participants
Number of Subjects With Solicited Local Symptoms Grade 3 Swelling	3 Participants	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

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

Assessed solicited general symptoms were drowsiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Drowsiness = Drowsiness that prevented normal activity, Grade 3 Loss of appetite = Not eating at all. Related = symptom assessed by the investigator as causally related to study vaccination. Analysis was done for sub-cohort 1 only.

Outcome measures

Outcome measures
Measure	Inv_MMR_CO Group n=731 Participants Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Com_MMR_CO Group n=268 Participants Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Inv_MMR_I Group Subjects received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_I Group Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).	Inv_MMR_S Group Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_S Group Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Number of Subjects With Solicited General Symptoms Any Drowsiness	199 Participants	72 Participants	—	—	—	—
Number of Subjects With Solicited General Symptoms Grade 3 Drowsiness	10 Participants	3 Participants	—	—	—	—
Number of Subjects With Solicited General Symptoms Related Drowsiness	180 Participants	63 Participants	—	—	—	—
Number of Subjects With Solicited General Symptoms Any Loss of appetite	154 Participants	59 Participants	—	—	—	—
Number of Subjects With Solicited General Symptoms Grade 3 Loss of appetite	2 Participants	2 Participants	—	—	—	—
Number of Subjects With Solicited General Symptoms Related Loss of appetite	135 Participants	56 Participants	—	—	—	—

SECONDARY outcome

Timeframe: During the 43-day (Days 0-42) post-vaccination period

Any fever = fever ≥ 38°C; Grade 3 fever = fever \> 39.5°C; Related = fever assessed by the investigator as causally related to study vaccination.

Outcome measures

Outcome measures
Measure	Inv_MMR_CO Group n=731 Participants Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Com_MMR_CO Group n=268 Participants Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Inv_MMR_I Group n=767 Participants Subjects received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_I Group n=291 Participants Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).	Inv_MMR_S Group n=1291 Participants Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_S Group n=481 Participants Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Number of Subjects Reporting Fever Any fever	177 Participants	67 Participants	146 Participants	58 Participants	257 Participants	96 Participants
Number of Subjects Reporting Fever Grade 3 fever	7 Participants	6 Participants	14 Participants	9 Participants	21 Participants	8 Participants
Number of Subjects Reporting Fever Related fever	100 Participants	32 Participants	27 Participants	11 Participants	52 Participants	25 Participants

SECONDARY outcome

Timeframe: During the 43-day (Days 0-42) post-vaccination period

Assessed MMR specific symptoms were parotid gland swelling and any suspected signs of meningism including febrile convulsions. Any = occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination. Grade 3 Parotid/salivary gland swelling = Swelling accompanied with general symptoms. Grade 3 Sign of meningism (any suspected signs including febrile convulsions) = An event which prevented normal, everyday activities. Related = symptom assessed by the investigator as causally related to study vaccination.

Outcome measures

Outcome measures
Measure	Inv_MMR_CO Group n=731 Participants Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Com_MMR_CO Group n=268 Participants Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Inv_MMR_I Group n=767 Participants Subjects received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_I Group n=291 Participants Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).	Inv_MMR_S Group n=1291 Participants Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_S Group n=481 Participants Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Number of Subjects Reporting MMR Specific Solicited General Symptoms Grade 3 Parotid gland swelling	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting MMR Specific Solicited General Symptoms Related Parotid gland swelling	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants
Number of Subjects Reporting MMR Specific Solicited General Symptoms Any Sign of meningism	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting MMR Specific Solicited General Symptoms Grade 3 Sign of meningism	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting MMR Specific Solicited General Symptoms Related Sign of meningism	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting MMR Specific Solicited General Symptoms Any Parotid gland swelling	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: During the 43-day (Days 0-42) post-vaccination period

Assessed any rash, varicella-like rash, measles/rubella-like rash, Grade 3, related. Any= occurrence of rash regardless of intensity grade. Grade 3 measles/rubella/varicella-like rash = Rash with more than 150 lesions. Other Grade 3 Rash = Rash that prevented normal, everyday activities. Related= Rash assessed by the investigator as causally related to study vaccination.

Outcome measures

Outcome measures
Measure	Inv_MMR_CO Group n=731 Participants Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Com_MMR_CO Group n=268 Participants Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Inv_MMR_I Group n=767 Participants Subjects received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_I Group n=291 Participants Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).	Inv_MMR_S Group n=1291 Participants Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_S Group n=481 Participants Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Number of Subjects Reporting Investigator-confirmed Rash Generalized Grade 3	1 Participants	0 Participants	0 Participants	0 Participants	3 Participants	0 Participants
Number of Subjects Reporting Investigator-confirmed Rash Generalized Related	7 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects Reporting Investigator-confirmed Rash Any localized or generalized	61 Participants	28 Participants	37 Participants	12 Participants	56 Participants	23 Participants
Number of Subjects Reporting Investigator-confirmed Rash Any related	25 Participants	11 Participants	2 Participants	2 Participants	8 Participants	3 Participants
Number of Subjects Reporting Investigator-confirmed Rash Localized administration site	9 Participants	2 Participants	1 Participants	0 Participants	8 Participants	0 Participants
Number of Subjects Reporting Investigator-confirmed Rash Localized Varicella like	2 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Investigator-confirmed Rash Localized Measles/Rubella like	12 Participants	4 Participants	3 Participants	2 Participants	4 Participants	1 Participants
Number of Subjects Reporting Investigator-confirmed Rash Any with fever	11 Participants	7 Participants	5 Participants	1 Participants	6 Participants	1 Participants
Number of Subjects Reporting Investigator-confirmed Rash Any Varicella like	4 Participants	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Investigator-confirmed Rash Any Measles/Rubella like	14 Participants	5 Participants	3 Participants	2 Participants	4 Participants	2 Participants
Number of Subjects Reporting Investigator-confirmed Rash Any grade 3	3 Participants	0 Participants	1 Participants	0 Participants	3 Participants	0 Participants
Number of Subjects Reporting Investigator-confirmed Rash Localized any	50 Participants	24 Participants	27 Participants	9 Participants	42 Participants	19 Participants
Number of Subjects Reporting Investigator-confirmed Rash Localized other site	41 Participants	22 Participants	26 Participants	9 Participants	36 Participants	19 Participants
Number of Subjects Reporting Investigator-confirmed Rash Localized with fever	8 Participants	6 Participants	4 Participants	0 Participants	4 Participants	1 Participants
Number of Subjects Reporting Investigator-confirmed Rash Localized Grade 3	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Investigator-confirmed Rash Localized related	18 Participants	10 Participants	2 Participants	2 Participants	7 Participants	2 Participants
Number of Subjects Reporting Investigator-confirmed Rash Generalized with fever	3 Participants	1 Participants	1 Participants	1 Participants	2 Participants	0 Participants
Number of Subjects Reporting Investigator-confirmed Rash Generalized Varicella like	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Investigator-confirmed Rash Generalized Measles/Rubella like	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects Reporting Investigator-confirmed Rash Generalized any	12 Participants	4 Participants	10 Participants	3 Participants	15 Participants	4 Participants

SECONDARY outcome

Timeframe: During the entire study period (from Day 0 up to Day 180)

Population: This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.

NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.

Outcome measures

Outcome measures
Measure	Inv_MMR_CO Group n=802 Participants Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Com_MMR_CO Group n=298 Participants Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Inv_MMR_I Group n=796 Participants Subjects received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_I Group n=303 Participants Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).	Inv_MMR_S Group n=1319 Participants Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_S Group n=489 Participants Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Number of Subjects With New Onset Chronic Diseases (NOCDs)	8 Participants	4 Participants	6 Participants	0 Participants	11 Participants	3 Participants

SECONDARY outcome

Timeframe: During the entire study period (from Day 0 up to Day 180)

Population: This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.

The number of subjects reporting adverse events resulting in Emergency Room (ER) visits is reported.

Outcome measures

Outcome measures
Measure	Inv_MMR_CO Group n=802 Participants Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Com_MMR_CO Group n=298 Participants Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Inv_MMR_I Group n=796 Participants Subjects received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_I Group n=303 Participants Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).	Inv_MMR_S Group n=1319 Participants Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_S Group n=489 Participants Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits	61 Participants	29 Participants	64 Participants	22 Participants	102 Participants	36 Participants

SECONDARY outcome

Timeframe: During the 43-day (Days 0-42) post-vaccination period

Population: This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Outcome measures

Outcome measures
Measure	Inv_MMR_CO Group n=802 Participants Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Com_MMR_CO Group n=298 Participants Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Inv_MMR_I Group n=796 Participants Subjects received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_I Group n=303 Participants Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).	Inv_MMR_S Group n=1319 Participants Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_S Group n=489 Participants Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Number of Subjects With Unsolicited Adverse Events (AEs)	276 Participants	90 Participants	314 Participants	112 Participants	508 Participants	186 Participants

SECONDARY outcome

Timeframe: During the entire study period (from Day 0 up to Day 180)

Population: This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.

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

Outcome measures

Outcome measures
Measure	Inv_MMR_CO Group n=802 Participants Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Com_MMR_CO Group n=298 Participants Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Inv_MMR_I Group n=796 Participants Subjects received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_I Group n=303 Participants Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).	Inv_MMR_S Group n=1319 Participants Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_S Group n=489 Participants Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Number of Subjects With Serious Adverse Events (SAEs)	4 Participants	0 Participants	14 Participants	1 Participants	25 Participants	9 Participants

Adverse Events

Inv_MMR_CO Group

Serious events: 4 serious events

Other events: 544 other events

Deaths: 0 deaths

Com_MMR_CO Group

Serious events: 0 serious events

Other events: 198 other events

Deaths: 0 deaths

Inv_MMR_I Group

Serious events: 14 serious events

Other events: 410 other events

Deaths: 0 deaths

Com_MMR_I Group

Serious events: 1 serious events

Other events: 156 other events

Deaths: 0 deaths

Inv_MMR_S Group

Serious events: 25 serious events

Other events: 702 other events

Deaths: 0 deaths

Com_MMR_S Group

Serious events: 9 serious events

Other events: 279 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Inv_MMR_CO Group n=802 participants at risk Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Com_MMR_CO Group n=298 participants at risk Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Inv_MMR_I Group n=796 participants at risk Subjects received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_I Group n=303 participants at risk Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).	Inv_MMR_S Group n=1319 participants at risk Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_S Group n=489 participants at risk Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/796 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/1319 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.20% 1/489 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Gastrointestinal disorders Abdominal discomfort	0.12% 1/802 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/796 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/1319 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/489 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Gastrointestinal disorders Abdominal pain	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/796 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.08% 1/1319 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/489 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Gastrointestinal disorders Cyclic vomiting syndrome	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/796 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.08% 1/1319 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/489 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Gastrointestinal disorders Gastritis	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.13% 1/796 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.15% 2/1319 • Number of events 4 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/489 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Gastrointestinal disorders Ileus	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/796 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.08% 1/1319 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/489 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Gastrointestinal disorders Inguinal hernia	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/796 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/1319 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.20% 1/489 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Gastrointestinal disorders Vomiting	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/796 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.08% 1/1319 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/489 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/796 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.08% 1/1319 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/489 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Infections and infestations Adenovirus infection	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/796 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/1319 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.20% 1/489 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Infections and infestations Appendicitis perforated	0.12% 1/802 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/796 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/1319 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/489 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Infections and infestations Bronchitis	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/796 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/1319 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.20% 1/489 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Infections and infestations Cellulitis	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/796 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.08% 1/1319 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/489 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Infections and infestations Gastroenteritis	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.25% 2/796 • Number of events 3 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.38% 5/1319 • Number of events 5 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.20% 1/489 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Infections and infestations Gastroenteritis rotavirus	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/796 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.08% 1/1319 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/489 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Infections and infestations Herpangina	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.13% 1/796 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/1319 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/489 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Infections and infestations Influenza	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/796 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.08% 1/1319 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.61% 3/489 • Number of events 3 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Infections and infestations Otitis media	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/796 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.15% 2/1319 • Number of events 2 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/489 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Infections and infestations Otitis media acute	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/796 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.15% 2/1319 • Number of events 2 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/489 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Infections and infestations Pneumonia	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.25% 2/796 • Number of events 2 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.33% 1/303 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/1319 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.61% 3/489 • Number of events 3 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Infections and infestations Pneumonia bacterial	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/796 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.08% 1/1319 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/489 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Infections and infestations Pyelonephritis	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/796 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.08% 1/1319 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/489 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Infections and infestations Tonsillitis	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/796 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.15% 2/1319 • Number of events 2 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.20% 1/489 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Infections and infestations Upper respiratory tract infection	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/796 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.15% 2/1319 • Number of events 2 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/489 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Infections and infestations Viral infection	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.13% 1/796 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/1319 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/489 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Infections and infestations Viral upper respiratory tract infection	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.13% 1/796 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/1319 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/489 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Injury, poisoning and procedural complications Accidental exposure to product	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.13% 1/796 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/1319 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/489 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Injury, poisoning and procedural complications Concussion	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/796 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/1319 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.20% 1/489 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Injury, poisoning and procedural complications Injury	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/796 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.08% 1/1319 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/489 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.13% 1/796 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/1319 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/489 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Metabolism and nutrition disorders Dehydration	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.13% 1/796 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.15% 2/1319 • Number of events 2 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/489 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.13% 1/796 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.08% 1/1319 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/489 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Nervous system disorders Febrile convulsion	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.13% 1/796 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/1319 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/489 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Renal and urinary disorders Dysuria	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.13% 1/796 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/1319 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/489 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Respiratory, thoracic and mediastinal disorders Adenoidal hypertrophy	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.13% 1/796 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.15% 2/1319 • Number of events 2 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/489 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Respiratory, thoracic and mediastinal disorders Asthma	0.25% 2/802 • Number of events 2 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.50% 4/796 • Number of events 4 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/1319 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.41% 2/489 • Number of events 3 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.12% 1/802 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/796 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/1319 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/489 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/796 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.08% 1/1319 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/489 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Respiratory, thoracic and mediastinal disorders Status asthmaticus	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/796 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.08% 1/1319 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/489 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.13% 1/796 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/1319 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/489 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Skin and subcutaneous tissue disorders Eczema vesicular	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/796 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.08% 1/1319 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/489 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/802 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/298 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/796 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.08% 1/1319 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/489 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).

Other adverse events

Other adverse events
Measure	Inv_MMR_CO Group n=802 participants at risk Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Com_MMR_CO Group n=298 participants at risk Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).	Inv_MMR_I Group n=796 participants at risk Subjects received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_I Group n=303 participants at risk Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).	Inv_MMR_S Group n=1319 participants at risk Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).	Com_MMR_S Group n=489 participants at risk Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Respiratory, thoracic and mediastinal disorders Cough	4.7% 38/802 • Number of events 41 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	5.4% 16/298 • Number of events 17 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	4.6% 37/796 • Number of events 41 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	2.6% 8/303 • Number of events 8 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	3.6% 47/1319 • Number of events 50 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	4.3% 21/489 • Number of events 22 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Metabolism and nutrition disorders Decreased appetite	19.5% 156/802 • Number of events 159 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	20.5% 61/298 • Number of events 61 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.25% 2/796 • Number of events 2 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.33% 1/303 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.23% 3/1319 • Number of events 3 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/489 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
General disorders Injection site erythema	21.2% 170/802 • Number of events 173 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	24.5% 73/298 • Number of events 75 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	18.5% 147/796 • Number of events 147 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	17.5% 53/303 • Number of events 53 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	18.3% 242/1319 • Number of events 242 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	18.4% 90/489 • Number of events 90 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
General disorders Injection site pain	38.5% 309/802 • Number of events 321 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	39.6% 118/298 • Number of events 125 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	19.2% 153/796 • Number of events 153 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	21.1% 64/303 • Number of events 64 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	21.1% 278/1319 • Number of events 278 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	25.2% 123/489 • Number of events 123 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
General disorders Injection site swelling	12.1% 97/802 • Number of events 97 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	10.4% 31/298 • Number of events 32 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	8.0% 64/796 • Number of events 64 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	7.6% 23/303 • Number of events 23 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	8.2% 108/1319 • Number of events 108 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	8.6% 42/489 • Number of events 42 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Infections and infestations Nasopharyngitis	3.1% 25/802 • Number of events 27 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	1.0% 3/298 • Number of events 3 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	9.7% 77/796 • Number of events 100 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	9.2% 28/303 • Number of events 32 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	8.5% 112/1319 • Number of events 143 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	9.2% 45/489 • Number of events 57 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
General disorders Pyrexia	22.1% 177/802 • Number of events 177 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	22.5% 67/298 • Number of events 67 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	18.3% 146/796 • Number of events 146 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	19.1% 58/303 • Number of events 58 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	19.5% 257/1319 • Number of events 257 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	19.6% 96/489 • Number of events 96 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Skin and subcutaneous tissue disorders Rash	7.6% 61/802 • Number of events 61 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	9.4% 28/298 • Number of events 28 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	4.6% 37/796 • Number of events 37 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	4.0% 12/303 • Number of events 12 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	4.2% 56/1319 • Number of events 56 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	4.7% 23/489 • Number of events 23 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Nervous system disorders Somnolence	24.8% 199/802 • Number of events 199 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	24.5% 73/298 • Number of events 73 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.13% 1/796 • Number of events 1 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/303 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/1319 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/489 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).
Infections and infestations Upper respiratory tract infection	3.4% 27/802 • Number of events 28 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	3.7% 11/298 • Number of events 11 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	6.9% 55/796 • Number of events 66 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	8.9% 27/303 • Number of events 35 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	7.0% 92/1319 • Number of events 107 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).	4.3% 21/489 • Number of events 22 • Solicited local and general symptoms (drowsiness and loss of appetite): during the 4-day (Days 0-3) post-vaccination period; Solicited general and Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 180).

Additional Information

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GlaxoSmithKline

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Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
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