Trial Outcomes & Findings for Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Children in Their Second Year of Life (NCT NCT01681992)

NCT ID: NCT01681992

Last Updated: 2021-01-07

Results Overview

For measles virus, a seroresponse was defined as post-vaccination anti-measles virus antibody concentration equal or above \[≥\] 200 mIU/mL (ELISA) among subjects who were seronegative (antibody concentration less than \[\<\] 150 mIU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv\_MMR\_Min/Inv\_MMR\_Med vaccine in terms of seroresponse rate for measles virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv\_MMR\_Min/Inv\_MMR\_Med was to be ≥ 90% for antibodies to measles virus.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 4538 participants
• Primary outcome timeframe: At Day 42
• Results posted on: 2021-01-07

Participant Flow

US sub-cohort: Subjects recruited in US and received Inv_MMR_Min or Inv_MMR_Med or Com_MMR (Lot 1 or 2) co-administered with Varivax (VV), Havrix (HAV) and Prevnar 13 (PCV-13) at Day 0. Non-US sub-cohort: Subjects recruited outside US and received Inv_MMR_Min or Inv_MMR_Med or Com_MMR (Lot 1 or 2) co-administered with VV and HAV at Day 0.

4538 subjects were registered in the study. 3 subjects were excluded because of invalid Informed Consent Forms and 19 subjects received a subject number but were not vaccinated. Therefore, the number of subjects started is 4516.

Participant milestones

Measure	Inv_MMR_Min Group Subjects received one dose of GlaxoSmithKline (GSK) Biologicals' measles, mumps, rubella (MMR) vaccine, Priorix (Inv\_MMR), from a minimum potency lot (Inv\_MMR\_Min), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects were also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Inv_MMR_Med Group Subjects received one dose of GlaxoSmithKline (GSK) Biologicals' measles, mumps, rubella (MMR) vaccine, Priorix (Inv\_MMR), from a mid-range or medium potency lot (Inv\_MMR\_Med), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects were also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Com_MMR Group Subjects received one dose of M-M-R II (Com\_MMR) vaccine (Lot 1 or Lot 2), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects were also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Overall Study STARTED	1493	1497	1526
Overall Study COMPLETED	1427	1427	1443
Overall Study NOT COMPLETED	66	70	83

Reasons for withdrawal

Measure	Inv_MMR_Min Group Subjects received one dose of GlaxoSmithKline (GSK) Biologicals' measles, mumps, rubella (MMR) vaccine, Priorix (Inv\_MMR), from a minimum potency lot (Inv\_MMR\_Min), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects were also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Inv_MMR_Med Group Subjects received one dose of GlaxoSmithKline (GSK) Biologicals' measles, mumps, rubella (MMR) vaccine, Priorix (Inv\_MMR), from a mid-range or medium potency lot (Inv\_MMR\_Med), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects were also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Com_MMR Group Subjects received one dose of M-M-R II (Com\_MMR) vaccine (Lot 1 or Lot 2), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects were also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Overall Study Adverse Event	3	2	3
Overall Study Lost to Follow-up	36	38	53
Overall Study As Per Sponsor Decision	0	0	1
Overall Study Protocol Violation	0	0	1
Overall Study Withdrawal by Subject	27	30	25

Baseline Characteristics

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Children in Their Second Year of Life

Baseline characteristics by cohort

Measure	Inv_MMR_Min Group n=1493 Participants Subjects received one dose of Inv\_MMR, from a minimum potency lot (Inv\_MMR\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Inv_MMR_Med Group n=1497 Participants Subjects received one dose of Inv\_MMR, from a mid-range or medium potency lot (Inv\_MMR\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Com_MMR Group n=1526 Participants Subjects received one dose of Com\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Total n=4516 Participants Total of all reporting groups
Age, Continuous	12.6 Months STANDARD_DEVIATION 0.9 • n=5 Participants	12.6 Months STANDARD_DEVIATION 0.9 • n=7 Participants	12.6 Months STANDARD_DEVIATION 0.9 • n=5 Participants	12.6 Months STANDARD_DEVIATION 0.9 • n=4 Participants
Sex: Female, Male Female	704 Participants n=5 Participants	718 Participants n=7 Participants	758 Participants n=5 Participants	2180 Participants n=4 Participants
Sex: Female, Male Male	789 Participants n=5 Participants	779 Participants n=7 Participants	768 Participants n=5 Participants	2336 Participants n=4 Participants
Race/Ethnicity, Customized African Heritage / African American	45 Participants n=5 Participants	53 Participants n=7 Participants	46 Participants n=5 Participants	144 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	3 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	362 Participants n=5 Participants	366 Participants n=7 Participants	367 Participants n=5 Participants	1095 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized White - Arabic / North African Heritage	8 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	24 Participants n=4 Participants
Race/Ethnicity, Customized White - Caucasian / European Heritage	1017 Participants n=5 Participants	1022 Participants n=7 Participants	1052 Participants n=5 Participants	3091 Participants n=4 Participants
Race/Ethnicity, Customized Other	55 Participants n=5 Participants	46 Participants n=7 Participants	49 Participants n=5 Participants	150 Participants n=4 Participants

PRIMARY outcome

Timeframe: At Day 42

Population: According-to-protocol (ATP) cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- \& post-dose 1 serology results \& were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample \& complied with post-dose 1 blood sample schedule.

For measles virus, a seroresponse was defined as post-vaccination anti-measles virus antibody concentration equal or above [≥] 200 mIU/mL (ELISA) among subjects who were seronegative (antibody concentration less than [<] 150 mIU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv_MMR_Min/Inv_MMR_Med vaccine in terms of seroresponse rate for measles virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv_MMR_Min/Inv_MMR_Med was to be ≥ 90% for antibodies to measles virus.

Outcome measures

Measure	Inv_MMR_Min Group n=1361 Participants Subjects received one dose of Inv\_MMR, from a minimum potency lot (Inv\_MMR\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Inv_MMR_Med Group n=1366 Participants Subjects received one dose of Inv\_MMR, from a mid-range or medium potency lot (Inv\_MMR\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Com_MMR Group n=1378 Participants Subjects received one dose of Com\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value (by Enzyme-linked Immunosorbent Assay [ELISA]) Anti-measles ≥ 150 mIU/mL	90.9 Percentage of subjects Interval 89.0 to 92.6	94.3 Percentage of subjects Interval 92.7 to 95.6	96.5 Percentage of subjects Interval 95.2 to 97.5
Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value (by Enzyme-linked Immunosorbent Assay [ELISA]) Anti-measles ≥ 200 mIU/mL	90.8 Percentage of subjects Interval 88.9 to 92.5	94.2 Percentage of subjects Interval 92.6 to 95.5	96.3 Percentage of subjects Interval 95.0 to 97.3

PRIMARY outcome

Timeframe: At Day 42

Population: ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- \& post-dose 1 serology results \& were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample \& complied with post-dose 1 blood sample schedule.

For mumps virus, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 EU/mL (ELISA) among subjects who were seronegative (antibody concentration < 5 EU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv_MMR_Min/Inv_MMR_Med vaccine in terms of seroresponse rate for mumps virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv_MMR_Min/Inv_MMR_Med was to be ≥ 90% for antibodies to mumps virus.

Outcome measures

Measure	Inv_MMR_Min Group n=1161 Participants Subjects received one dose of Inv\_MMR, from a minimum potency lot (Inv\_MMR\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Inv_MMR_Med Group n=1131 Participants Subjects received one dose of Inv\_MMR, from a mid-range or medium potency lot (Inv\_MMR\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Com_MMR Group n=1155 Participants Subjects received one dose of Com\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA) Anti-mumps ≥ 5 EU/mL	99.1 Percentage of subjects Interval 98.2 to 99.6	99.0 Percentage of subjects Interval 98.1 to 99.6	99.2 Percentage of subjects Interval 98.4 to 99.7
Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA) Anti-mumps ≥ 10 EU/mL	97.4 Percentage of subjects Interval 96.2 to 98.3	97.3 Percentage of subjects Interval 96.0 to 98.2	97.8 Percentage of subjects Interval 96.7 to 98.7

PRIMARY outcome

Timeframe: At Day 42

Population: ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- \& post-dose 1 serology results \& were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample \& complied with post-dose 1 blood sample schedule.

For mumps virus as measured by PRNT, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 4 End point Dilution 50% (ED50) (PRNT) among subjects who were seronegative (antibody concentration < 2.5 ED50) before dose 1.

Outcome measures

Measure	Inv_MMR_Min Group n=1252 Participants Subjects received one dose of Inv\_MMR, from a minimum potency lot (Inv\_MMR\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Inv_MMR_Med Group n=1265 Participants Subjects received one dose of Inv\_MMR, from a mid-range or medium potency lot (Inv\_MMR\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Com_MMR Group n=1287 Participants Subjects received one dose of Com\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value (by Plaque Reduction Neutralization Test [PRNT]) ≥ 2.5 ED50	79.1 Percentage of subjects Interval 76.7 to 81.3	81.6 Percentage of subjects Interval 79.3 to 83.7	87.5 Percentage of subjects Interval 85.6 to 89.2
Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value (by Plaque Reduction Neutralization Test [PRNT]) ≥ 4 ED50	71.2 Percentage of subjects Interval 68.6 to 73.7	73.4 Percentage of subjects Interval 70.8 to 75.8	80.6 Percentage of subjects Interval 78.3 to 82.7

PRIMARY outcome

Timeframe: At Day 42

Population: ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- \& post-dose 1 serology results \& were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample \& complied with post-dose 1 blood sample schedule.

For rubella virus, a seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 IU/mL (ELISA) among subjects who were seronegative (antibody concentration < 4 IU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv_MMR_Min/Inv_MMR_Med vaccine in terms of seroresponse rate for rubella virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv_MMR_Min/Inv_MMR_Med was to be ≥ 90% for antibodies to mumps virus.

Outcome measures

Measure	Inv_MMR_Min Group n=1359 Participants Subjects received one dose of Inv\_MMR, from a minimum potency lot (Inv\_MMR\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Inv_MMR_Med Group n=1366 Participants Subjects received one dose of Inv\_MMR, from a mid-range or medium potency lot (Inv\_MMR\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Com_MMR Group n=1376 Participants Subjects received one dose of Com\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA) ≥ 4 IU/mL	99.3 Percentage of subjects Interval 98.6 to 99.7	99.5 Percentage of subjects Interval 98.9 to 99.8	99.5 Percentage of subjects Interval 98.9 to 99.8
Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA) ≥ 10 IU/mL	96.8 Percentage of subjects Interval 95.5 to 97.7	97.3 Percentage of subjects Interval 96.1 to 98.2	98.5 Percentage of subjects Interval 97.6 to 99.1

PRIMARY outcome

Timeframe: At Day 42

Population: ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- \& post-dose 1 serology results \& were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample \& complied with post-dose 1 blood sample schedule.

Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL.

Outcome measures

Measure	Inv_MMR_Min Group n=1361 Participants Subjects received one dose of Inv\_MMR, from a minimum potency lot (Inv\_MMR\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Inv_MMR_Med Group n=1366 Participants Subjects received one dose of Inv\_MMR, from a mid-range or medium potency lot (Inv\_MMR\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Com_MMR Group n=1378 Participants Subjects received one dose of Com\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Anti-measles Virus Antibody Concentrations (by ELISA)	2209.9 mIU/mL Interval 2041.3 to 2392.4	2540.9 mIU/mL Interval 2368.8 to 2725.5	2787.7 mIU/mL Interval 2619.5 to 2966.7

PRIMARY outcome

Timeframe: At Day 42

Population: ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- \& post-dose 1 serology results \& were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample \& complied with post-dose 1 blood sample schedule.

Antibody concentrations were expressed as GMCs in EU/mL.

Outcome measures

Measure	Inv_MMR_Min Group n=1161 Participants Subjects received one dose of Inv\_MMR, from a minimum potency lot (Inv\_MMR\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Inv_MMR_Med Group n=1131 Participants Subjects received one dose of Inv\_MMR, from a mid-range or medium potency lot (Inv\_MMR\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Com_MMR Group n=1155 Participants Subjects received one dose of Com\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Anti-mumps Virus Antibody Concentrations (by ELISA)	58.7 EU/mL Interval 55.5 to 62.1	60.2 EU/mL Interval 56.8 to 63.7	71.6 EU/mL Interval 67.7 to 75.8

PRIMARY outcome

Timeframe: At Day 42

Population: ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- \& post-dose 1 serology results \& were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample \& complied with post-dose 1 blood sample schedule.

Antibody concentrations were expressed as Geometric Mean Titers (GMTs).

Outcome measures

Measure	Inv_MMR_Min Group n=1252 Participants Subjects received one dose of Inv\_MMR, from a minimum potency lot (Inv\_MMR\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Inv_MMR_Med Group n=1265 Participants Subjects received one dose of Inv\_MMR, from a mid-range or medium potency lot (Inv\_MMR\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Com_MMR Group n=1287 Participants Subjects received one dose of Com\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Anti-mumps Virus Antibody Concentrations (by PRNT)	9.8 Titers Interval 9.0 to 10.6	10.7 Titers Interval 9.9 to 11.5	16.3 Titers Interval 15.1 to 17.7

PRIMARY outcome

Timeframe: At Day 42

Population: ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- \& post-dose 1 serology results \& were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample \& complied with post-dose 1 blood sample schedule.

Antibody concentrations were expressed as GMCs in IU/mL.

Outcome measures

Measure	Inv_MMR_Min Group n=1359 Participants Subjects received one dose of Inv\_MMR, from a minimum potency lot (Inv\_MMR\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Inv_MMR_Med Group n=1366 Participants Subjects received one dose of Inv\_MMR, from a mid-range or medium potency lot (Inv\_MMR\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Com_MMR Group n=1376 Participants Subjects received one dose of Com\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Anti-rubella Virus Antibody Concentrations (by ELISA)	57.0 IU/mL Interval 54.1 to 60.0	56.9 IU/mL Interval 54.2 to 59.8	64.4 IU/mL Interval 61.4 to 67.5

SECONDARY outcome

Timeframe: At Day 84

Population: ATP cohort for analysis of immunogenicity post dose 2: all eligible subjects from US sub-cohort who received 2 doses of Inv\_MMR/Com\_MMR vaccine, with pre- \& post-dose 2 serology results for at least 1 vaccine antigen for MMR, did not meet elimination criteria up to Day 84 blood sample \& complied with post-dose 2 blood sample schedule.

For measles virus, a seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥ 200 mIU/mL (ELISA) among subjects who were seronegative (antibody concentration < 150 mIU/mL) before dose 1.

Outcome measures

Measure	Inv_MMR_Min Group n=245 Participants Subjects received one dose of Inv\_MMR, from a minimum potency lot (Inv\_MMR\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Inv_MMR_Med Group n=258 Participants Subjects received one dose of Inv\_MMR, from a mid-range or medium potency lot (Inv\_MMR\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Com_MMR Group n=257 Participants Subjects received one dose of Com\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA) ≥ 150 mIU/mL	99.6 Percentage of subjects Interval 97.7 to 100.0	98.8 Percentage of subjects Interval 96.6 to 99.8	98.8 Percentage of subjects Interval 96.6 to 99.8
Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA) ≥ 200 mIU/mL	99.6 Percentage of subjects Interval 97.7 to 100.0	98.4 Percentage of subjects Interval 96.1 to 99.6	98.4 Percentage of subjects Interval 96.1 to 99.6

SECONDARY outcome

Timeframe: At Day 84

Population: ATP cohort for analysis of immunogenicity post dose 2: all eligible subjects from US sub-cohort who received 2 doses of Inv\_MMR/Com\_MMR vaccine, with pre- \& post-dose 2 serology results for at least 1 vaccine antigen for MMR, did not meet elimination criteria up to Day 84 blood sample \& complied with post-dose 2 blood sample schedule.

For mumps virus, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 EU/mL (ELISA) among subjects who were seronegative (antibody concentration < 5 EU/mL) before dose 1.

Outcome measures

Measure	Inv_MMR_Min Group n=216 Participants Subjects received one dose of Inv\_MMR, from a minimum potency lot (Inv\_MMR\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Inv_MMR_Med Group n=199 Participants Subjects received one dose of Inv\_MMR, from a mid-range or medium potency lot (Inv\_MMR\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Com_MMR Group n=212 Participants Subjects received one dose of Com\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA) ≥ 5 EU/mL	99.1 Percentage of subjects Interval 96.7 to 99.9	100 Percentage of subjects Interval 98.2 to 100.0	99.1 Percentage of subjects Interval 96.6 to 99.9
Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA) ≥ 10 EU/mL	99.1 Percentage of subjects Interval 96.7 to 99.9	100 Percentage of subjects Interval 98.2 to 100.0	98.6 Percentage of subjects Interval 95.9 to 99.7

SECONDARY outcome

Timeframe: At Day 84

Population: ATP cohort for analysis of immunogenicity post dose 2: all eligible subjects from US sub-cohort who received 2 doses of Inv\_MMR/Com\_MMR vaccine, with pre- \& post-dose 2 serology results for at least 1 vaccine antigen for MMR, did not meet elimination criteria up to Day 84 blood sample \& complied with post-dose 2 blood sample schedule.

For rubella virus, a seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 IU/mL (ELISA) among subjects who were seronegative (antibody concentration < 4 IU/mL) before dose 1.

Outcome measures

Measure	Inv_MMR_Min Group n=245 Participants Subjects received one dose of Inv\_MMR, from a minimum potency lot (Inv\_MMR\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Inv_MMR_Med Group n=259 Participants Subjects received one dose of Inv\_MMR, from a mid-range or medium potency lot (Inv\_MMR\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Com_MMR Group n=255 Participants Subjects received one dose of Com\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA) ≥ 4 IU/mL	100 Percentage of subjects Interval 98.5 to 100.0	100 Percentage of subjects Interval 98.6 to 100.0	100 Percentage of subjects Interval 98.6 to 100.0
Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA) ≥ 10 IU/mL	99.6 Percentage of subjects Interval 97.7 to 100.0	99.6 Percentage of subjects Interval 97.9 to 100.0	99.6 Percentage of subjects Interval 97.8 to 100.0

SECONDARY outcome

Timeframe: At Day 84

Population: ATP cohort for analysis of immunogenicity post dose 2: all eligible subjects from US sub-cohort who received 2 doses of Inv\_MMR/Com\_MMR vaccine, with pre- \& post-dose 2 serology results for at least 1 vaccine antigen for MMR, did not meet elimination criteria up to Day 84 blood sample \& complied with post-dose 2 blood sample schedule.

Antibody concentrations were expressed as GMCs in mIU/mL.

Outcome measures

Measure	Inv_MMR_Min Group n=245 Participants Subjects received one dose of Inv\_MMR, from a minimum potency lot (Inv\_MMR\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Inv_MMR_Med Group n=258 Participants Subjects received one dose of Inv\_MMR, from a mid-range or medium potency lot (Inv\_MMR\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Com_MMR Group n=257 Participants Subjects received one dose of Com\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Anti-measles Virus Antibody Concentrations (by ELISA)	4803.5 mIU/mL Interval 4290.4 to 5378.0	4557.7 mIU/mL Interval 4061.5 to 5114.4	4453.9 mIU/mL Interval 3951.9 to 5019.8

SECONDARY outcome

Timeframe: At Day 84

Population: ATP cohort for analysis of immunogenicity post dose 2: all eligible subjects from US sub-cohort who received 2 doses of Inv\_MMR/Com\_MMR vaccine, with pre- \& post-dose 2 serology results for at least 1 vaccine antigen for MMR, did not meet elimination criteria up to Day 84 blood sample \& complied with post-dose 2 blood sample schedule.

Antibody concentrations were expressed as GMCs in EU/mL.

Outcome measures

Measure	Inv_MMR_Min Group n=216 Participants Subjects received one dose of Inv\_MMR, from a minimum potency lot (Inv\_MMR\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Inv_MMR_Med Group n=199 Participants Subjects received one dose of Inv\_MMR, from a mid-range or medium potency lot (Inv\_MMR\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Com_MMR Group n=212 Participants Subjects received one dose of Com\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Anti-mumps Virus Antibody Concentrations (by ELISA)	88.9 EU/mL Interval 80.4 to 98.3	94.1 EU/mL Interval 85.3 to 103.8	86.4 EU/mL Interval 77.4 to 96.5

SECONDARY outcome

Timeframe: At Day 84

Population: ATP cohort for analysis of immunogenicity post dose 2: all eligible subjects from US sub-cohort who received 2 doses of Inv\_MMR/Com\_MMR vaccine, with pre- \& post-dose 2 serology results for at least 1 vaccine antigen for MMR, did not meet elimination criteria up to Day 84 blood sample \& complied with post-dose 2 blood sample schedule.

Antibody concentrations were expressed as GMCs in IU/mL.

Outcome measures

Measure	Inv_MMR_Min Group n=245 Participants Subjects received one dose of Inv\_MMR, from a minimum potency lot (Inv\_MMR\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Inv_MMR_Med Group n=259 Participants Subjects received one dose of Inv\_MMR, from a mid-range or medium potency lot (Inv\_MMR\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Com_MMR Group n=255 Participants Subjects received one dose of Com\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Anti-rubella Virus Antibody Concentrations (by ELISA)	112.7 IU/mL Interval 104.1 to 122.0	110.7 IU/mL Interval 102.9 to 119.1	110.9 IU/mL Interval 101.8 to 120.8

SECONDARY outcome

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

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

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

Outcome measures

Measure	Inv_MMR_Min Group n=1453 Participants Subjects received one dose of Inv\_MMR, from a minimum potency lot (Inv\_MMR\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Inv_MMR_Med Group n=1464 Participants Subjects received one dose of Inv\_MMR, from a mid-range or medium potency lot (Inv\_MMR\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Com_MMR Group n=1482 Participants Subjects received one dose of Com\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Number of Subjects With Any Solicited Local Adverse Events (AEs) Post Dose 1 Any pain	261 Participants	262 Participants	301 Participants
Number of Subjects With Any Solicited Local Adverse Events (AEs) Post Dose 1 Any redness	232 Participants	256 Participants	286 Participants
Number of Subjects With Any Solicited Local Adverse Events (AEs) Post Dose 1 Any swelling	89 Participants	97 Participants	122 Participants

SECONDARY outcome

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

Population: TVC included all vaccinated subjects with at least one vaccine administration of either Inv\_MMR lots or Com\_MMR lots documented.

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

Outcome measures

Measure	Inv_MMR_Min Group n=1427 Participants Subjects received one dose of Inv\_MMR, from a minimum potency lot (Inv\_MMR\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Inv_MMR_Med Group n=1440 Participants Subjects received one dose of Inv\_MMR, from a mid-range or medium potency lot (Inv\_MMR\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Com_MMR Group n=1456 Participants Subjects received one dose of Com\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Number of Subjects With Any Solicited Local AEs Post Dose 2 Any pain	170 Participants	183 Participants	196 Participants
Number of Subjects With Any Solicited Local AEs Post Dose 2 Any redness	159 Participants	196 Participants	217 Participants
Number of Subjects With Any Solicited Local AEs Post Dose 2 Any swelling	67 Participants	91 Participants	96 Participants

SECONDARY outcome

Timeframe: During the 15-day (Days 0-14) post-vaccination period

Population: TVC included all vaccinated subjects with at least one vaccine administration of either Inv\_MMR lots or Com\_MMR lots documented.

Assessed solicited general AEs were drowsiness, irritability/fussiness and loss of appetite. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.

Outcome measures

Measure	Inv_MMR_Min Group n=1454 Participants Subjects received one dose of Inv\_MMR, from a minimum potency lot (Inv\_MMR\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Inv_MMR_Med Group n=1466 Participants Subjects received one dose of Inv\_MMR, from a mid-range or medium potency lot (Inv\_MMR\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Com_MMR Group n=1486 Participants Subjects received one dose of Com\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Number of Subjects With Any Solicited General AEs Post Dose 1 Any drowsiness	551 Participants	565 Participants	582 Participants
Number of Subjects With Any Solicited General AEs Post Dose 1 Any irritability / fussiness	749 Participants	792 Participants	788 Participants
Number of Subjects With Any Solicited General AEs Post Dose 1 Any loss of appetite	570 Participants	589 Participants	591 Participants

SECONDARY outcome

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

Population: TVC included all vaccinated subjects with at least one vaccine administration of either Inv\_MMR lots or Com\_MMR lots documented.

Any fever = Fever (axillary) ≥ 38°C.

Outcome measures

Measure	Inv_MMR_Min Group n=1454 Participants Subjects received one dose of Inv\_MMR, from a minimum potency lot (Inv\_MMR\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Inv_MMR_Med Group n=1466 Participants Subjects received one dose of Inv\_MMR, from a mid-range or medium potency lot (Inv\_MMR\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Com_MMR Group n=1486 Participants Subjects received one dose of Com\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Number of Subjects Reporting Any Fever Post Dose 1	582 Participants	617 Participants	618 Participants

SECONDARY outcome

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

Population: TVC included all vaccinated subjects with at least one vaccine administration of either Inv\_MMR lots or Com\_MMR lots documented.

Any fever = Fever (axillary) ≥ 38°C.

Outcome measures

Measure	Inv_MMR_Min Group n=1426 Participants Subjects received one dose of Inv\_MMR, from a minimum potency lot (Inv\_MMR\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Inv_MMR_Med Group n=1443 Participants Subjects received one dose of Inv\_MMR, from a mid-range or medium potency lot (Inv\_MMR\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Com_MMR Group n=1455 Participants Subjects received one dose of Com\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Number of Subjects Reporting Any Fever Post Dose 2	458 Participants	471 Participants	499 Participants

SECONDARY outcome

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

Population: TVC included all vaccinated subjects with at least one vaccine administration of either Inv\_MMR lots or Com\_MMR lots documented.

Assessed were any localized or generalized rash, rash with fever, varicella-like rash and measles/rubella-like rash. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.

Outcome measures

Measure	Inv_MMR_Min Group n=1454 Participants Subjects received one dose of Inv\_MMR, from a minimum potency lot (Inv\_MMR\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Inv_MMR_Med Group n=1466 Participants Subjects received one dose of Inv\_MMR, from a mid-range or medium potency lot (Inv\_MMR\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Com_MMR Group n=1486 Participants Subjects received one dose of Com\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Number of Subjects Reporting Any Rash Post Dose 1 Any localized or generalized	328 Participants	322 Participants	333 Participants
Number of Subjects Reporting Any Rash Post Dose 1 Any with fever	115 Participants	133 Participants	131 Participants
Number of Subjects Reporting Any Rash Post Dose 1 Any varicella like	57 Participants	53 Participants	45 Participants
Number of Subjects Reporting Any Rash Post Dose 1 Any measles/rubella like	53 Participants	61 Participants	68 Participants

SECONDARY outcome

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

Population: TVC included all vaccinated subjects with at least one vaccine administration of either Inv\_MMR lots or Com\_MMR lots documented.

Assessed were any localized or generalized rash, rash with fever, varicella-like rash and measles/rubella-like rash. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.

Outcome measures

Measure	Inv_MMR_Min Group n=1426 Participants Subjects received one dose of Inv\_MMR, from a minimum potency lot (Inv\_MMR\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Inv_MMR_Med Group n=1443 Participants Subjects received one dose of Inv\_MMR, from a mid-range or medium potency lot (Inv\_MMR\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Com_MMR Group n=1455 Participants Subjects received one dose of Com\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Number of Subjects Reporting Any Rash Post Dose 2 Any localized or generalized	129 Participants	150 Participants	141 Participants
Number of Subjects Reporting Any Rash Post Dose 2 Any with fever	52 Participants	63 Participants	53 Participants
Number of Subjects Reporting Any Rash Post Dose 2 Any varicella like	0 Participants	0 Participants	1 Participants
Number of Subjects Reporting Any Rash Post Dose 2 Any measles/rubella like	22 Participants	14 Participants	14 Participants

SECONDARY outcome

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

Population: TVC included all vaccinated subjects with at least one vaccine administration of either Inv\_MMR lots or Com\_MMR lots documented.

Assessed MMR specific solicited general AEs were any suspected signs of meningism including febrile convulsions and parotid/salivary gland swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.

Outcome measures

Measure	Inv_MMR_Min Group n=1454 Participants Subjects received one dose of Inv\_MMR, from a minimum potency lot (Inv\_MMR\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Inv_MMR_Med Group n=1466 Participants Subjects received one dose of Inv\_MMR, from a mid-range or medium potency lot (Inv\_MMR\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Com_MMR Group n=1486 Participants Subjects received one dose of Com\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Number of Subjects Reporting Any MMR Specific Solicited General AEs Post Dose 1 Any parotid gland swelling	3 Participants	2 Participants	3 Participants
Number of Subjects Reporting Any MMR Specific Solicited General AEs Post Dose 1 Any febrile convulsion	3 Participants	4 Participants	3 Participants

SECONDARY outcome

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

Population: TVC included all vaccinated subjects with at least one vaccine administration of either Inv\_MMR lots or Com\_MMR lots documented.

Assessed MMR specific solicited general AEs were any suspected signs of meningism including febrile convulsions and parotid/salivary gland swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.

Outcome measures

Measure	Inv_MMR_Min Group n=1426 Participants Subjects received one dose of Inv\_MMR, from a minimum potency lot (Inv\_MMR\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Inv_MMR_Med Group n=1443 Participants Subjects received one dose of Inv\_MMR, from a mid-range or medium potency lot (Inv\_MMR\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Com_MMR Group n=1455 Participants Subjects received one dose of Com\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Number of Subjects Reporting Any MMR Specific Solicited General AEs Post Dose 2 Any parotid gland swelling	1 Participants	2 Participants	0 Participants
Number of Subjects Reporting Any MMR Specific Solicited General AEs Post Dose 2 Any febrile convulsion	2 Participants	6 Participants	4 Participants

SECONDARY outcome

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

Population: TVC included all vaccinated subjects with at least one vaccine administration of either Inv\_MMR lots or Com\_MMR lots documented.

Unsolicited AE was defined as any AE reported in reported in addition to those solicited during the clinical study and any solicited AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.

Outcome measures

Measure	Inv_MMR_Min Group n=1493 Participants Subjects received one dose of Inv\_MMR, from a minimum potency lot (Inv\_MMR\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Inv_MMR_Med Group n=1497 Participants Subjects received one dose of Inv\_MMR, from a mid-range or medium potency lot (Inv\_MMR\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Com_MMR Group n=1526 Participants Subjects received one dose of Com\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Number of Subjects Reporting Any Unsolicited AES Post Dose 1	762 Participants	794 Participants	777 Participants

SECONDARY outcome

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

Population: TVC included all vaccinated subjects with at least one vaccine administration of either Inv\_MMR lots or Com\_MMR lots documented.

Unsolicited AE was defined as any AE reported in reported in addition to those solicited during the clinical study and any solicited AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.

Outcome measures

Measure	Inv_MMR_Min Group n=1449 Participants Subjects received one dose of Inv\_MMR, from a minimum potency lot (Inv\_MMR\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Inv_MMR_Med Group n=1464 Participants Subjects received one dose of Inv\_MMR, from a mid-range or medium potency lot (Inv\_MMR\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Com_MMR Group n=1483 Participants Subjects received one dose of Com\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Number of Subjects Reporting Any Unsolicited AES Post Dose 2	667 Participants	703 Participants	690 Participants

SECONDARY outcome

Timeframe: From Day 0 through the end of the study (Day 222)

Population: TVC included all vaccinated subjects with at least one vaccine administration of either Inv\_MMR lots or Com\_MMR lots documented.

AEs of specific interest included new onset chronic disease (NOCD) (e.g., autoimmune disorders, asthma, type I diabetes, vasculitis, celiac disease, conditions associated with sub-acute or chronic thrombocytopenia and allergies) and AEs prompting emergency room (ER) visits.

Outcome measures

Measure	Inv_MMR_Min Group n=1493 Participants Subjects received one dose of Inv\_MMR, from a minimum potency lot (Inv\_MMR\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Inv_MMR_Med Group n=1497 Participants Subjects received one dose of Inv\_MMR, from a mid-range or medium potency lot (Inv\_MMR\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Com_MMR Group n=1526 Participants Subjects received one dose of Com\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Number of Subjects Reporting Any AEs of Specific Interest Any NOCD	35 Participants	39 Participants	33 Participants
Number of Subjects Reporting Any AEs of Specific Interest Any AE prompting ER visit	348 Participants	361 Participants	347 Participants

SECONDARY outcome

Timeframe: From Day 0 through the end of the study (Day 222)

Population: TVC included all vaccinated subjects with at least one vaccine administration of either Inv\_MMR lots or Com\_MMR lots documented.

SAEs assessed include any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity.

Outcome measures

Measure	Inv_MMR_Min Group n=1493 Participants Subjects received one dose of Inv\_MMR, from a minimum potency lot (Inv\_MMR\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Inv_MMR_Med Group n=1497 Participants Subjects received one dose of Inv\_MMR, from a mid-range or medium potency lot (Inv\_MMR\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Com_MMR Group n=1526 Participants Subjects received one dose of Com\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Number of Subjects Reporting Any Serious Adverse Events (SAEs)	91 Participants	102 Participants	92 Participants

Adverse Events

Inv_MMR_Min Group

Serious events: 91 serious events

Other events: 1299 other events

Deaths: 1 deaths

Inv_MMR_Med Group

Serious events: 102 serious events

Other events: 1311 other events

Deaths: 0 deaths

Com_MMR Group

Serious events: 92 serious events

Other events: 1330 other events

Deaths: 1 deaths

Serious adverse events

Measure	Inv_MMR_Min Group n=1493 participants at risk Subjects received one dose of Inv\_MMR, from a minimum potency lot (Inv\_MMR\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Inv_MMR_Med Group n=1497 participants at risk Subjects received one dose of Inv\_MMR, from a mid-range or medium potency lot (Inv\_MMR\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Com_MMR Group n=1526 participants at risk Subjects received one dose of Com\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Blood and lymphatic system disorders Anaemia	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Blood and lymphatic system disorders Haemolytic anaemia	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Blood and lymphatic system disorders Hypochromic anaemia	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1497 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Blood and lymphatic system disorders Leukopenia	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Blood and lymphatic system disorders Neutropenia	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Blood and lymphatic system disorders Thrombocytopenia	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Cardiac disorders Supraventricular tachycardia	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Anal fistula	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Constipation	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Diarrhoea	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1497 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.26% 4/1526 • Number of events 4 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Food poisoning	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Gastritis	0.20% 3/1493 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Inguinal hernia	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Intestinal haemorrhage	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Perianal erythema	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Teething	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Vomiting	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Drowning	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Influenza like illness	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Pyrexia	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.27% 4/1497 • Number of events 4 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Hepatobiliary disorders Liver disorder	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Immune system disorders Allergy to arthropod bite	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Adenovirus infection	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Anal abscess	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Atypical pneumonia	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Bacteraemia	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Bronchiolitis	0.40% 6/1493 • Number of events 6 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.47% 7/1497 • Number of events 7 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Bronchitis	0.27% 4/1493 • Number of events 5 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.67% 10/1497 • Number of events 10 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.52% 8/1526 • Number of events 8 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Bronchitis viral	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Campylobacter gastroenteritis	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Cellulitis	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Cellulitis orbital	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Clostridium difficile colitis	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Conjunctivitis	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Croup infectious	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1497 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.26% 4/1526 • Number of events 4 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Cystitis klebsiella	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Dengue fever	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Diarrhoea infectious	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1526 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Ear infection	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Empyema	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Encephalitis	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Encephalitis brain stem	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Enterococcal bacteraemia	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Escherichia urinary tract infection	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Exanthema subitum	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Gastroenteritis	1.1% 16/1493 • Number of events 16 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	1.3% 19/1497 • Number of events 19 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.66% 10/1526 • Number of events 10 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Gastroenteritis bacterial	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Gastroenteritis rotavirus	0.40% 6/1493 • Number of events 6 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1497 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.46% 7/1526 • Number of events 7 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Gastroenteritis salmonella	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Gastroenteritis viral	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Hand-foot-and-mouth disease	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.26% 4/1526 • Number of events 4 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Herpangina	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1526 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Influenza	0.20% 3/1493 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Laryngitis	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.26% 4/1526 • Number of events 4 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Laryngotracheitis obstructive	0.07% 1/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Lower respiratory tract infection	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Meningitis	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Nail bed infection	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Nasopharyngitis	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1497 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Nosocomial infection	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Otitis media	0.20% 3/1493 • Number of events 4 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1497 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Otitis media acute	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Otitis media viral	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Otosalpingitis	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Periorbital cellulitis	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Pharyngitis	0.20% 3/1493 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Pharyngotonsillitis	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.33% 5/1497 • Number of events 5 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Pneumonia	0.47% 7/1493 • Number of events 7 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.94% 14/1497 • Number of events 14 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.66% 10/1526 • Number of events 10 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Pneumonia bacterial	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Pneumonia respiratory syncytial viral	0.20% 3/1493 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Pneumonia viral	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.40% 6/1497 • Number of events 7 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Pyelonephritis	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Pyelonephritis acute	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Respiratory syncytial virus bronchiolitis	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Respiratory syncytial virus bronchitis	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Respiratory syncytial virus infection	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Rhinitis	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Sepsis	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Sinusitis	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Skin candida	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Staphylococcal bacteraemia	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Staphylococcal infection	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Subcutaneous abscess	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Tonsillitis	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Upper respiratory tract infection	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1497 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1526 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Urinary tract infection	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Viral infection	0.20% 3/1493 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Viral pharyngitis	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Viral tonsillitis	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Viral upper respiratory tract infection	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Wound infection	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Accidental poisoning	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Burns second degree	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Chest injury	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Child maltreatment syndrome	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Concussion	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Contusion	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Face injury	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Femur fracture	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Foreign body	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Head injury	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Laceration	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Limb crushing injury	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Mouth injury	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Multiple injuries	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Poisoning	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Thermal burn	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1526 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Toxicity to various agents	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Metabolism and nutrition disorders Dehydration	0.27% 4/1493 • Number of events 5 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.47% 7/1497 • Number of events 7 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.39% 6/1526 • Number of events 6 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Metabolism and nutrition disorders Electrolyte imbalance	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Musculoskeletal and connective tissue disorders Juvenile idiopathic arthritis	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Nervous system disorders Burning sensation	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Nervous system disorders Epilepsy	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Nervous system disorders Febrile convulsion	0.47% 7/1493 • Number of events 8 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.87% 13/1497 • Number of events 15 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.52% 8/1526 • Number of events 8 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Nervous system disorders Intracranial pressure increased	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Nervous system disorders Seizure	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Respiratory, thoracic and mediastinal disorders Apnoea	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Respiratory, thoracic and mediastinal disorders Wheezing	0.07% 1/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Angioedema	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Henoch-schonlein purpura	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Petechiae	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Rash	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Stevens-johnson syndrome	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Toxic skin eruption	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Vascular disorders Circulatory collapse	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Vascular disorders Phlebitis superficial	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Vascular disorders Thrombophlebitis	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).

Other adverse events

Measure	Inv_MMR_Min Group n=1493 participants at risk Subjects received one dose of Inv\_MMR, from a minimum potency lot (Inv\_MMR\_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Inv_MMR_Med Group n=1497 participants at risk Subjects received one dose of Inv\_MMR, from a mid-range or medium potency lot (Inv\_MMR\_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv\_MMR vaccine (Inv\_MMR\_Release), for the second dose. Inv\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.	Com_MMR Group n=1526 participants at risk Subjects received one dose of Com\_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com\_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com\_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Reproductive system and breast disorders Scrotal swelling	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Immune system disorders Seasonal allergy	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Abdominal discomfort	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Abdominal distension	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Abdominal pain	0.20% 3/1493 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1526 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Abdominal pain upper	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Pregnancy, puerperium and perinatal conditions Abortion	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Abscess	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Acarodermatitis	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Accidental exposure to product	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Acute sinusitis	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Adenoiditis	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Adenoviral conjunctivitis	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Adenovirus infection	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Adverse drug reaction	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Psychiatric disorders Agitation	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Immune system disorders Allergy to animal	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Blood and lymphatic system disorders Anaemia	0.40% 6/1493 • Number of events 6 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.33% 5/1497 • Number of events 5 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.26% 4/1526 • Number of events 4 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Anal fissure	0.20% 3/1493 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1497 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1526 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Angular cheilitis	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Animal bite	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Nervous system disorders Aphonia	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Aphthous ulcer	0.40% 6/1493 • Number of events 6 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.47% 7/1497 • Number of events 7 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1526 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Application site erythema	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Application site hypersensitivity	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Cardiac disorders Arrhythmia	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Arthropod bite	1.6% 24/1493 • Number of events 29 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	1.4% 21/1497 • Number of events 23 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.79% 12/1526 • Number of events 13 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Arthropod sting	0.20% 3/1493 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Respiratory, thoracic and mediastinal disorders Asthma	0.07% 1/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.33% 5/1497 • Number of events 5 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1526 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Reproductive system and breast disorders Balanoposthitis	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1497 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Eye disorders Blepharitis	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Investigations Blood alkaline phosphatase increased	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Investigations Body temperature increased	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Body tinea	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.47% 7/1493 • Number of events 8 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.27% 4/1497 • Number of events 5 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.52% 8/1526 • Number of events 9 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Bronchiolitis	1.2% 18/1493 • Number of events 22 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	1.5% 22/1497 • Number of events 22 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	1.4% 21/1526 • Number of events 22 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Bronchitis	5.4% 81/1493 • Number of events 92 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	6.4% 96/1497 • Number of events 115 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	5.0% 77/1526 • Number of events 95 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Bronchitis viral	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.47% 7/1493 • Number of events 7 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1497 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Psychiatric disorders Bruxism	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Bullous impetigo	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Burn infection	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Burns second degree	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1497 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Campylobacter gastroenteritis	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Campylobacter infection	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Candida infection	0.40% 6/1493 • Number of events 7 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.60% 9/1497 • Number of events 9 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.46% 7/1526 • Number of events 7 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Candida nappy rash	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Investigations Cardiac murmur	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Respiratory, thoracic and mediastinal disorders Catarrh	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Cellulitis	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1526 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Nervous system disorders Cerebrovascular accident	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Ear and labyrinth disorders Cerumen impaction	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Cheilitis	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Colitis	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Eye disorders Conjunctival hyperaemia	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Conjunctivitis	4.2% 63/1493 • Number of events 67 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	5.3% 79/1497 • Number of events 90 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	5.2% 79/1526 • Number of events 87 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Eye disorders Conjunctivitis allergic	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Conjunctivitis bacterial	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Conjunctivitis viral	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Constipation	0.74% 11/1493 • Number of events 11 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.73% 11/1497 • Number of events 13 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.39% 6/1526 • Number of events 6 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Contusion	0.54% 8/1493 • Number of events 9 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.47% 7/1497 • Number of events 8 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.59% 9/1526 • Number of events 9 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Respiratory, thoracic and mediastinal disorders Cough	4.0% 59/1493 • Number of events 68 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	4.3% 64/1497 • Number of events 74 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	4.9% 75/1526 • Number of events 84 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Coxsackie viral infection	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Croup infectious	0.27% 4/1493 • Number of events 4 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.73% 11/1497 • Number of events 11 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.79% 12/1526 • Number of events 13 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Crying	0.27% 4/1493 • Number of events 5 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.27% 4/1497 • Number of events 4 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.33% 5/1526 • Number of events 7 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Cryptosporidiosis infection	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Cystitis	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Decreased activity	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Metabolism and nutrition disorders Decreased appetite	38.2% 571/1493 • Number of events 575 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	39.6% 593/1497 • Number of events 595 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	38.9% 593/1526 • Number of events 593 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Metabolism and nutrition disorders Dehydration	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Dermal cyst	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Dermatitis	0.60% 9/1493 • Number of events 9 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.60% 9/1497 • Number of events 10 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	1.1% 17/1526 • Number of events 17 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Dermatitis atopic	1.0% 15/1493 • Number of events 16 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.94% 14/1497 • Number of events 16 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.85% 13/1526 • Number of events 15 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Dermatitis contact	0.20% 3/1493 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1526 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Dermatitis diaper	0.80% 12/1493 • Number of events 12 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	1.2% 18/1497 • Number of events 19 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	1.4% 21/1526 • Number of events 21 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Congenital, familial and genetic disorders Dermoid cyst	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Product Issues Device occlusion	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Diarrhoea	4.9% 73/1493 • Number of events 83 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	4.7% 71/1497 • Number of events 76 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	4.9% 75/1526 • Number of events 80 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Metabolism and nutrition disorders Disaccharide metabolism disorder	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Discomfort	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Nervous system disorders Drooling	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Immune system disorders Drug hypersensitivity	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1526 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Dyspepsia	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1497 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Ear canal abrasion	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Ear and labyrinth disorders Ear disorder	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Ear infection	1.3% 19/1493 • Number of events 19 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	1.3% 19/1497 • Number of events 20 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.79% 12/1526 • Number of events 13 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Ear and labyrinth disorders Ear pain	0.40% 6/1493 • Number of events 6 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.47% 7/1497 • Number of events 7 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.39% 6/1526 • Number of events 6 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Ecchymosis	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Eczema	1.1% 16/1493 • Number of events 16 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.47% 7/1497 • Number of events 7 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.46% 7/1526 • Number of events 9 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Eczema impetiginous	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Enteritis	1.3% 19/1493 • Number of events 19 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	1.4% 21/1497 • Number of events 23 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	1.2% 19/1526 • Number of events 20 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Enterobiasis	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Enterocolitis	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Enterovirus infection	0.20% 3/1493 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.13% 2/1493 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.27% 4/1497 • Number of events 4 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Erythema	19.3% 288/1493 • Number of events 394 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	22.1% 331/1497 • Number of events 455 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	23.7% 362/1526 • Number of events 505 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Erythema infectiosum	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Exanthema subitum	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.33% 5/1497 • Number of events 5 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Excoriation	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Exposure to communicable disease	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Exposure to toxic agent	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Eye disorders Eye discharge	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1526 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Eye infection	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Eye injury	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Eye disorders Eye oedema	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Eye disorders Eye swelling	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Eye disorders Eyelid bleeding	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Eye disorders Eyelid cyst	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Eyelid injury	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Eye disorders Eyelid oedema	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Face injury	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1497 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Faeces discoloured	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Metabolism and nutrition disorders Failure to thrive	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Fall	0.20% 3/1493 • Number of events 5 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.27% 4/1497 • Number of events 4 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.46% 7/1526 • Number of events 8 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Fatigue	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Metabolism and nutrition disorders Feeding disorder	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Feeling hot	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Flatulence	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Vascular disorders Flushing	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Folliculitis	0.20% 3/1493 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Immune system disorders Food allergy	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Food poisoning	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Foot fracture	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Foreign body	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Functional gastrointestinal disorder	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Fungal infection	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Fungal skin infection	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1497 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Furuncle	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Gait disturbance	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Investigations Gastric ph decreased	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Gastritis	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1526 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Gastritis viral	0.20% 3/1493 • Number of events 4 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Gastroenteritis	5.9% 88/1493 • Number of events 93 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	6.3% 95/1497 • Number of events 107 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	6.1% 93/1526 • Number of events 100 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Gastroenteritis norovirus	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Gastroenteritis salmonella	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Gastroenteritis viral	0.47% 7/1493 • Number of events 7 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.40% 6/1497 • Number of events 6 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.59% 9/1526 • Number of events 9 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Genital candidiasis	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Reproductive system and breast disorders Genital erythema	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Reproductive system and breast disorders Genital labial adhesions	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Gingival disorder	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Gingival pain	0.27% 4/1493 • Number of events 5 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.27% 4/1497 • Number of events 4 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Gingivitis	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Glossodynia	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Haematochezia	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Vascular disorders Haematoma	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Investigations Haemoglobin decreased	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Haemorrhoids	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Hand-foot-and-mouth disease	0.67% 10/1493 • Number of events 10 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	1.5% 23/1497 • Number of events 23 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.66% 10/1526 • Number of events 11 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Head injury	0.54% 8/1493 • Number of events 8 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.47% 7/1497 • Number of events 7 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.46% 7/1526 • Number of events 7 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Nervous system disorders Headache	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Herpangina	0.60% 9/1493 • Number of events 9 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.53% 8/1497 • Number of events 8 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.52% 8/1526 • Number of events 8 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Herpes virus infection	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Hordeolum	0.20% 3/1493 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1497 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Immune system disorders Hypersensitivity	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Blood and lymphatic system disorders Hypochromic anaemia	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Metabolism and nutrition disorders Hyposideraemia	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Impetigo	0.40% 6/1493 • Number of events 6 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.47% 7/1497 • Number of events 7 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.59% 9/1526 • Number of events 9 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Congenital, familial and genetic disorders Inborn error of metabolism	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Infected bite	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Influenza	0.47% 7/1493 • Number of events 8 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.73% 11/1497 • Number of events 13 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.66% 10/1526 • Number of events 10 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Influenza like illness	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Ingrowing nail	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Inguinal hernia	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Injection site bruising	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Injection site erythema	0.74% 11/1493 • Number of events 11 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	1.0% 15/1497 • Number of events 15 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.59% 9/1526 • Number of events 9 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Injection site haematoma	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1526 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Injection site haemorrhage	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1497 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Injection site induration	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.27% 4/1497 • Number of events 4 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Injection site inflammation	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Injection site mass	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Injection site nodule	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Injection site pain	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Injection site papule	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Injection site reaction	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Injection site swelling	0.20% 3/1493 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.33% 5/1497 • Number of events 5 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Injection site urticaria	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Injury	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.26% 4/1526 • Number of events 4 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Psychiatric disorders Insomnia	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Intertrigo	0.20% 3/1493 • Number of events 4 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1497 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Psychiatric disorders Irritability	50.7% 757/1493 • Number of events 781 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	53.1% 795/1497 • Number of events 815 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	52.0% 793/1526 • Number of events 815 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Eye disorders Keratitis	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Congenital, familial and genetic disorders Keratosis follicular	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Laceration	0.20% 3/1493 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.40% 6/1497 • Number of events 6 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.46% 7/1526 • Number of events 7 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Eye disorders Lacrimation increased	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Metabolism and nutrition disorders Lactase deficiency	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Metabolism and nutrition disorders Lactose intolerance	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Nervous system disorders Language disorder	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Laryngitis	2.3% 34/1493 • Number of events 35 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	2.3% 34/1497 • Number of events 37 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	1.8% 27/1526 • Number of events 30 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Nervous system disorders Lethargy	0.07% 1/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Lice infestation	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.27% 4/1497 • Number of events 4 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Limb injury	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Lip disorder	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Lip injury	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.27% 4/1497 • Number of events 4 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Lip ulceration	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Local swelling	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Localised infection	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Respiratory, thoracic and mediastinal disorders Lower respiratory tract congestion	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Lower respiratory tract infection	0.27% 4/1493 • Number of events 4 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.27% 4/1497 • Number of events 5 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.33% 5/1526 • Number of events 5 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Lower respiratory tract infection viral	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Blood and lymphatic system disorders Lymphadenitis	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Blood and lymphatic system disorders Lymphadenopathy	0.54% 8/1493 • Number of events 8 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.33% 5/1497 • Number of events 5 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Macule	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Malaise	0.20% 3/1493 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 4 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Malocclusion	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Mass	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Mastitis	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Ear and labyrinth disorders Middle ear inflammation	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Miliaria	0.40% 6/1493 • Number of events 6 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.27% 4/1497 • Number of events 4 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.26% 4/1526 • Number of events 4 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Immune system disorders Milk allergy	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Molluscum contagiosum	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Psychiatric disorders Mood altered	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Mouth injury	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Mouth ulceration	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Immune system disorders Multiple allergies	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Musculoskeletal and connective tissue disorders Myalgia	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Mycoplasma infection	0.33% 5/1493 • Number of events 5 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Congenital, familial and genetic disorders Naevus flammeus	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.60% 9/1493 • Number of events 9 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.80% 12/1497 • Number of events 12 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.66% 10/1526 • Number of events 12 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Nasopharyngitis	9.9% 148/1493 • Number of events 177 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	11.8% 176/1497 • Number of events 210 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	8.8% 134/1526 • Number of events 154 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Nausea	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Musculoskeletal and connective tissue disorders Neck mass	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Psychiatric disorders Nervousness	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Noninfective gingivitis	0.07% 1/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Eye disorders Ocular hyperaemia	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Onychomadesis	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Oral candidiasis	0.47% 7/1493 • Number of events 7 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.52% 8/1526 • Number of events 8 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Oral disorder	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Oral fungal infection	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Oral herpes	0.20% 3/1493 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Orchitis	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1497 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1526 • Number of events 6 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Otitis externa	0.33% 5/1493 • Number of events 5 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1497 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1526 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Otitis media	6.4% 95/1493 • Number of events 120 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	6.6% 99/1497 • Number of events 117 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	7.6% 116/1526 • Number of events 143 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Otitis media acute	3.1% 46/1493 • Number of events 55 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	3.3% 49/1497 • Number of events 60 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	3.7% 57/1526 • Number of events 65 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Ear and labyrinth disorders Otorrhoea	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1526 • Number of events 4 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Pain	22.4% 334/1493 • Number of events 431 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	22.4% 336/1497 • Number of events 445 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	24.8% 378/1526 • Number of events 500 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Musculoskeletal and connective tissue disorders Pain in extremity	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Palatal ulcer	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Parasitic gastroenteritis	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Paronychia	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Reproductive system and breast disorders Penile adhesion	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Reproductive system and breast disorders Penile erythema	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Pregnancy, puerperium and perinatal conditions Perinatal brain damage	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Reproductive system and breast disorders Perineal erythema	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Periodontal disease	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Periorbital cellulitis	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Peripheral swelling	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Pharyngitis	3.3% 50/1493 • Number of events 61 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	3.5% 53/1497 • Number of events 56 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	3.6% 55/1526 • Number of events 57 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Pharyngitis streptococcal	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Pharyngotonsillitis	0.94% 14/1493 • Number of events 15 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	1.0% 15/1497 • Number of events 16 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	1.1% 17/1526 • Number of events 17 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Congenital, familial and genetic disorders Phimosis	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Pneumonia	0.33% 5/1493 • Number of events 5 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.53% 8/1497 • Number of events 8 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.59% 9/1526 • Number of events 9 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Pneumonia mycoplasmal	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Pneumonia viral	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Nervous system disorders Poor quality sleep	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Procedural vomiting	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Protein-losing gastroenteropathy	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Prurigo	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1497 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Pseudocroup	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Nervous system disorders Psychomotor hyperactivity	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Pyelonephritis	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Pyoderma	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pyogenic granuloma	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Pyrexia	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Radial head dislocation	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Radius fracture	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Rash vesicular	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Regurgitation	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Respiratory syncytial virus bronchiolitis	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Respiratory syncytial virus infection	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.27% 4/1497 • Number of events 4 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Respiratory tract infection	1.6% 24/1493 • Number of events 25 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	1.6% 24/1497 • Number of events 28 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	1.4% 22/1526 • Number of events 30 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Respiratory tract infection viral	0.27% 4/1493 • Number of events 5 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.60% 9/1497 • Number of events 10 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.46% 7/1526 • Number of events 11 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Psychiatric disorders Restlessness	0.07% 1/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Rhinitis	2.5% 37/1493 • Number of events 53 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	3.3% 49/1497 • Number of events 56 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	2.0% 30/1526 • Number of events 33 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.27% 4/1493 • Number of events 4 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.39% 6/1526 • Number of events 6 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	2.1% 32/1493 • Number of events 39 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	1.7% 25/1497 • Number of events 33 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	2.6% 39/1526 • Number of events 41 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Rhinovirus infection	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Road traffic accident	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Roseola	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1497 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Salivary gland enlargement	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Salivary hypersecretion	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Salmonellosis	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Scarlet fever	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Respiratory, thoracic and mediastinal disorders Sinus disorder	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Sinusitis	0.74% 11/1493 • Number of events 12 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.67% 10/1497 • Number of events 10 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.46% 7/1526 • Number of events 7 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Sinusitis bacterial	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Skin abrasion	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.33% 5/1497 • Number of events 5 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.33% 5/1526 • Number of events 5 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Skin bacterial infection	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Skin burning sensation	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Skin candida	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Skin infection	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Skin warm	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Skin wound	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Nervous system disorders Sleep phase rhythm disturbance	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Respiratory, thoracic and mediastinal disorders Sneezing	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Nervous system disorders Somnolence	36.9% 551/1493 • Number of events 552 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	37.9% 567/1497 • Number of events 569 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	38.1% 582/1526 • Number of events 582 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Spider naevus	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Staphylococcal abscess	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Staphylococcal infection	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Investigations Staphylococcus test positive	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Stomatitis	0.20% 3/1493 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.40% 6/1497 • Number of events 6 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1526 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Streptococcal infection	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Subcutaneous abscess	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1526 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Superinfection bacterial	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Swelling	8.2% 123/1493 • Number of events 156 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	10.2% 152/1497 • Number of events 188 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	11.1% 170/1526 • Number of events 218 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Nervous system disorders Syncope	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Musculoskeletal and connective tissue disorders Synovitis	0.20% 3/1493 • Number of events 4 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Congenital, familial and genetic disorders Talipes	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Psychiatric disorders Tearfulness	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Teething	4.2% 62/1493 • Number of events 86 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	4.7% 71/1497 • Number of events 104 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	4.2% 64/1526 • Number of events 82 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Reproductive system and breast disorders Testicular pain	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Thermal burn	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.27% 4/1497 • Number of events 4 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.26% 4/1526 • Number of events 4 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Nervous system disorders Tongue biting	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Tongue blistering	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Tongue injury	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Tonsillitis	2.3% 34/1493 • Number of events 36 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	1.6% 24/1497 • Number of events 27 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	2.2% 34/1526 • Number of events 36 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Tonsillitis bacterial	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Tooth abscess	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Tooth discolouration	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Tooth disorder	0.20% 3/1493 • Number of events 4 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Tooth injury	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Toothache	1.5% 22/1493 • Number of events 31 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	1.1% 17/1497 • Number of events 21 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	1.1% 17/1526 • Number of events 22 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Tracheitis	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1497 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Tracheobronchitis	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Ear and labyrinth disorders Tympanic membrane perforation	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Upper respiratory tract infection	23.4% 350/1493 • Number of events 475 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	23.6% 354/1497 • Number of events 473 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	23.9% 365/1526 • Number of events 485 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Upper respiratory tract infection bacterial	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Urinary tract infection	0.27% 4/1493 • Number of events 5 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.26% 4/1526 • Number of events 5 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Skin and subcutaneous tissue disorders Urticaria	0.27% 4/1493 • Number of events 4 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.33% 5/1497 • Number of events 5 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1526 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Vaccination complication	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1497 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1526 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Vaccination site erythema	0.47% 7/1493 • Number of events 7 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.40% 6/1497 • Number of events 6 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.52% 8/1526 • Number of events 8 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Vaccination site haematoma	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Vaccination site pain	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Vaccination site rash	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Vaccination site reaction	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Vaccination site swelling	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Varicella	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
General disorders Vessel puncture site haemorrhage	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Viral infection	3.0% 45/1493 • Number of events 50 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	3.4% 51/1497 • Number of events 57 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	3.7% 57/1526 • Number of events 61 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Viral pharyngitis	0.33% 5/1493 • Number of events 5 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.13% 2/1497 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1526 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Viral rash	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Viral rhinitis	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.20% 3/1526 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Viral tonsillitis	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1497 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Viral upper respiratory tract infection	0.13% 2/1493 • Number of events 2 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.40% 6/1497 • Number of events 6 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.72% 11/1526 • Number of events 12 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Gastrointestinal disorders Vomiting	2.9% 43/1493 • Number of events 55 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	2.8% 42/1497 • Number of events 45 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	3.1% 48/1526 • Number of events 51 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Vulvitis	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Vulvovaginitis	0.00% 0/1493 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.07% 1/1526 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Respiratory, thoracic and mediastinal disorders Wheezing	0.20% 3/1493 • Number of events 3 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.60% 9/1497 • Number of events 9 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.46% 7/1526 • Number of events 7 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Injury, poisoning and procedural complications Wound	0.27% 4/1493 • Number of events 4 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.67% 10/1497 • Number of events 10 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.33% 5/1526 • Number of events 5 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
Infections and infestations Wound infection	0.07% 1/1493 • Number of events 1 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1497 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).	0.00% 0/1526 • Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

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.
• Publication restrictions are in place

Restriction type: OTHER