Trial Outcomes & Findings for Immunogenicity of GSKs' MMR Vaccine (209762) vs. M-M-R® II, When Given With Routine Vaccines at 12-15 Months of Age (NCT NCT00861744)

NCT ID: NCT00861744

Last Updated: 2020-01-03

Results Overview

Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations \<150 mIU/mL prior to vaccination.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 1259 participants
• Primary outcome timeframe: At Day 42 after administration of a dose of Priorix vaccine.
• Results posted on: 2020-01-03

Participant Flow

The study was divided in 3 phases: the active phase (up to Day 42), the extended safety follow-up (ESFU) phase (up to Day 180) and the antibody persistence phase (up to Day 730).

The number of subjects enrolled was 1259. 39 subjects were enrolled in the study but did not receive a subject number and were never vaccinated.

Participant milestones

Measure	Priorix 1 Group Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Study STARTED	304	304	304	308
Overall Study COMPLETED	287	275	280	275
Overall Study NOT COMPLETED	17	29	24	33

Reasons for withdrawal

Measure	Priorix 1 Group Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Overall Study Adverse Event	0	0	0	1
Overall Study Lost to Follow-up	7	19	17	12
Overall Study Withdrawal by Subject	10	6	6	19
Overall Study Protocol Violation	0	1	0	0
Overall Study Migration from study area	0	3	1	0
Overall Study Blood draws	0	0	0	1

Baseline Characteristics

Immunogenicity of GSKs' MMR Vaccine (209762) vs. M-M-R® II, When Given With Routine Vaccines at 12-15 Months of Age

Baseline characteristics by cohort

Measure	Priorix 1 Group n=304 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=304 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=304 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=308 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Total n=1220 Participants Total of all reporting groups
Age, Continuous	12.4 Months STANDARD_DEVIATION 0.75 • n=93 Participants	12.4 Months STANDARD_DEVIATION 0.73 • n=4 Participants	12.2 Months STANDARD_DEVIATION 0.56 • n=27 Participants	12.4 Months STANDARD_DEVIATION 0.75 • n=483 Participants	12.4 Months STANDARD_DEVIATION 0.70 • n=36 Participants
Sex: Female, Male Female	156 Participants n=93 Participants	144 Participants n=4 Participants	157 Participants n=27 Participants	139 Participants n=483 Participants	596 Participants n=36 Participants
Sex: Female, Male Male	148 Participants n=93 Participants	160 Participants n=4 Participants	147 Participants n=27 Participants	169 Participants n=483 Participants	624 Participants n=36 Participants

PRIMARY outcome

Timeframe: At Day 42 after administration of a dose of Priorix vaccine.

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.

Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.

Outcome measures

Measure	Priorix 1 Group n=247 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=240 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=240 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=249 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value.	245 Subjects	236 Subjects	236 Subjects	248 Subjects

PRIMARY outcome

Timeframe: At Day 42 after administration of a dose of Priorix vaccine.

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.

Anti-mumps virus antibody cut-off-value assessed was ≥ 51 Estimated Dose 50 (ED50). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <24 ED50 prior to vaccination.

Outcome measures

Measure	Priorix 1 Group n=193 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=202 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=195 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=192 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Number of Subjects With Anti-mumps Virus Antibody Titer Equal to or Above the Cut-off-value.	175 Subjects	183 Subjects	175 Subjects	175 Subjects

PRIMARY outcome

Timeframe: At Day 42 after administration of a dose of Priorix vaccine.

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.

Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL).

Outcome measures

Measure	Priorix 1 Group n=247 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=238 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=239 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=249 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.	244 Subjects	235 Subjects	233 Subjects	249 Subjects

SECONDARY outcome

Timeframe: At Day 42 after administration of a dose of Varivax vaccine.

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.

Anti-varicella virus antibody cut-off-value assessed was ≥ 75 milli-International Units per milliliter (mIU/mL).

Outcome measures

Measure	Priorix 1 Group n=245 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=238 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=240 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=246 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Number of Subjects With Anti-varicella Antibody Concentration Equal to or Above the Cut-off-value.	240 Subjects	230 Subjects	230 Subjects	241 Subjects

SECONDARY outcome

Timeframe: At Day 42 after administration of a dose of Priorix vaccine.

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.

Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.

Outcome measures

Measure	Priorix 1 Group n=247 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=240 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=240 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=249 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Anti-measles Virus Antibody Concentrations	2798.7 mIU/mL Interval 2544.8 to 3077.9	2878.2 mIU/mL Interval 2607.0 to 3177.7	2593.1 mIU/mL Interval 2350.3 to 2861.1	2949.5 mIU/mL Interval 2698.4 to 3224.0

SECONDARY outcome

Timeframe: At Day 42 after administration of a dose of Priorix vaccine.

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.

Antibody concentrations are expressed as Geometric Mean Titer (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody titer < 24 ED50 prior to vaccination.

Outcome measures

Measure	Priorix 1 Group n=193 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=202 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=195 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=192 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Anti-mumps Virus Antibody Concentrations	242.0 Titers Interval 204.5 to 286.5	265.0 Titers Interval 221.8 to 316.5	253.4 Titers Interval 213.4 to 300.9	267.6 Titers Interval 224.2 to 319.5

SECONDARY outcome

Timeframe: At Day 42 after administration of a dose of Priorix vaccine.

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.

Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.

Outcome measures

Measure	Priorix 1 Group n=247 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=238 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=239 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=249 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Anti-rubella Virus Antibody Concentrations	72.2 IU/mL Interval 65.6 to 79.6	77.7 IU/mL Interval 70.4 to 85.7	68.2 IU/mL Interval 61.8 to 75.3	89.4 IU/mL Interval 81.4 to 98.2

SECONDARY outcome

Timeframe: At Day 42 after vaccination

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.

Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL.

Outcome measures

Measure	Priorix 1 Group n=128 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=127 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=128 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=126 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Anti-S. Pneumoniae Antibody Concentrations (by Serotype). Anti-S.PNEU-4	3.57 µg/mL Interval 3.04 to 4.2	3.72 µg/mL Interval 3.21 to 4.31	3.40 µg/mL Interval 2.88 to 4.0	3.80 µg/mL Interval 3.17 to 4.56
Anti-S. Pneumoniae Antibody Concentrations (by Serotype). Anti-S. PNEU-6B	5.68 µg/mL Interval 4.78 to 6.76	5.87 µg/mL Interval 5.02 to 6.87	5.41 µg/mL Interval 4.66 to 6.28	7.22 µg/mL Interval 6.28 to 8.29
Anti-S. Pneumoniae Antibody Concentrations (by Serotype). Anti-S.PNEU 9V	6.56 µg/mL Interval 5.66 to 7.6	7.30 µg/mL Interval 6.35 to 8.38	5.81 µg/mL Interval 4.97 to 6.78	7.80 µg/mL Interval 6.81 to 8.93
Anti-S. Pneumoniae Antibody Concentrations (by Serotype). Anti-S.PNEU-14	9.23 µg/mL Interval 8.03 to 10.61	8.33 µg/mL Interval 7.3 to 9.51	7.58 µg/mL Interval 6.55 to 8.76	7.97 µg/mL Interval 6.95 to 9.14
Anti-S. Pneumoniae Antibody Concentrations (by Serotype). Anti-S.PNEU-18 C	6.20 µg/mL Interval 5.3 to 7.26	6.62 µg/mL Interval 5.76 to 7.6	6.15 µg/mL Interval 5.25 to 7.21	6.73 µg/mL Interval 5.74 to 7.91
Anti-S. Pneumoniae Antibody Concentrations (by Serotype). Anti-S.PNEU-19 F	2.42 µg/mL Interval 2.05 to 2.85	2.46 µg/mL Interval 2.11 to 2.88	2.34 µg/mL Interval 2.0 to 2.73	2.59 µg/mL Interval 2.23 to 3.0
Anti-S. Pneumoniae Antibody Concentrations (by Serotype). Anti-S.PNEU-23 F	9.34 µg/mL Interval 7.76 to 11.25	9.27 µg/mL Interval 7.82 to 10.99	8.33 µg/mL Interval 6.88 to 10.1	11.49 µg/mL Interval 9.67 to 13.66

SECONDARY outcome

Timeframe: At Day 42 after administration of a dose of Varivax vaccine.

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.

Antibody concentrations are expressed as Geometric Mean Titers (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody concentration < 25 mIU/mL prior to vaccination.

Outcome measures

Measure	Priorix 1 Group n=245 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=238 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=240 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=246 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Anti-varicella Antibody Concentrations.	245.5 mIU/mL Interval 229.0 to 263.3	235.2 mIU/mL Interval 217.4 to 254.4	236.0 mIU/mL Interval 218.0 to 255.5	255.9 mIU/mL Interval 240.4 to 272.4

SECONDARY outcome

Timeframe: At Day 42 after administration of a dose of Havrix vaccine.

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.

Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-hepatitis A virus antibody concentrations <15 mIU/mL prior to vaccination.

Outcome measures

Measure	Priorix 1 Group n=117 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=112 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=111 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=124 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Anti-hepatitis A Virus Antibody Concentrations.	33.8 mIU/mL Interval 28.8 to 39.6	39.2 mIU/mL Interval 33.1 to 46.5	39.4 mIU/mL Interval 32.7 to 47.5	42.1 mIU/mL Interval 35.8 to 49.6

SECONDARY outcome

Timeframe: At Day 42 after administration of a dose of Havrix vaccine.

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.

Anti-hepatitis A antibody cut-off-value assessed was ≥15 milli-International Units per milliliter (mIU/mL).

Outcome measures

Measure	Priorix 1 Group n=117 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=112 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=111 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=124 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Number of Subjects With Anti-hepatitis A Antibody Concentrations Equal to or Above the Cut-off-value.	98 Subjects	99 Subjects	94 Subjects	110 Subjects

SECONDARY outcome

Timeframe: At Day 0 before vaccination

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.

Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL.

Outcome measures

Measure	Priorix 1 Group n=129 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=130 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=130 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=119 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Anti-S. Pneumoniae Antibody Concentrations (by Serotype). Anti-S.PNEU-4	0.54 µg/mL Interval 0.46 to 0.65	0.61 µg/mL Interval 0.52 to 0.72	0.67 µg/mL Interval 0.58 to 0.78	0.67 µg/mL Interval 0.56 to 0.81
Anti-S. Pneumoniae Antibody Concentrations (by Serotype). Anti-S.PNEU-6B	0.53 µg/mL Interval 0.43 to 0.66	0.57 µg/mL Interval 0.46 to 0.7	0.52 µg/mL Interval 0.43 to 0.64	0.67 µg/mL Interval 0.56 to 0.8
Anti-S. Pneumoniae Antibody Concentrations (by Serotype). Anti-S.PNEU-9V	1.01 µg/mL Interval 0.85 to 1.2	1.13 µg/mL Interval 0.97 to 1.32	1.04 µg/mL Interval 0.88 to 1.23	1.26 µg/mL Interval 1.06 to 1.49
Anti-S. Pneumoniae Antibody Concentrations (by Serotype). Anti-S.PNEU-14	3.01 µg/mL Interval 2.6 to 3.47	2.82 µg/mL Interval 2.42 to 3.28	2.54 µg/mL Interval 2.21 to 2.92	2.76 µg/mL Interval 2.38 to 3.2
Anti-S. Pneumoniae Antibody Concentrations (by Serotype). Anti-S.PNEU-18C	0.88 µg/mL Interval 0.74 to 1.03	0.97 µg/mL Interval 0.83 to 1.13	0.97 µg/mL Interval 0.83 to 1.14	1.00 µg/mL Interval 0.86 to 1.15
Anti-S. Pneumoniae Antibody Concentrations (by Serotype). Anti-S.PNEU-19F	0.40 µg/mL Interval 0.32 to 0.5	0.40 µg/mL Interval 0.33 to 0.5	0.44 µg/mL Interval 0.36 to 0.53	0.45 µg/mL Interval 0.37 to 0.56
Anti-S. Pneumoniae Antibody Concentrations (by Serotype). Anti-S.PNEU-23 F	0.64 µg/mL Interval 0.51 to 0.82	0.63 µg/mL Interval 0.51 to 0.77	0.65 µg/mL Interval 0.52 to 0.81	0.85 µg/mL Interval 0.67 to 1.08

SECONDARY outcome

Timeframe: At 1 year post-vaccination

Population: The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.

Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL).

Outcome measures

Measure	Priorix 1 Group n=213 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=215 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=218 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=210 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value	211 Subjects	211 Subjects	218 Subjects	209 Subjects

SECONDARY outcome

Timeframe: At 2 years post-vaccination

Population: The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.

Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL).

Outcome measures

Measure	Priorix 1 Group n=171 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=159 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=169 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=166 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value	171 Subjects	159 Subjects	168 Subjects	166 Subjects

SECONDARY outcome

Timeframe: At 2 years post-vaccination

Population: The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.

Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.

Outcome measures

Measure	Priorix 1 Group n=171 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=159 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=169 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=166 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Anti-measles Virus Antibody Concentrations	3361.1 mIU/mL Interval 2922.3 to 3865.6	3963.8 mIU/mL Interval 3479.3 to 4515.7	3360.3 mIU/mL Interval 2923.3 to 3862.7	4022.1 mIU/mL Interval 3507.7 to 4611.9

SECONDARY outcome

Timeframe: At 1 year post-vaccination

Population: The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.

Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.

Outcome measures

Measure	Priorix 1 Group n=213 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=215 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=218 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=210 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Anti-measles Virus Antibody Concentrations	3224.3 mIU/mL Interval 2840.1 to 3660.5	3708.2 mIU/mL Interval 3226.2 to 4262.2	3534.7 mIU/mL Interval 3139.9 to 3979.1	3828.1 mIU/mL Interval 3371.3 to 4346.7

SECONDARY outcome

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

Population: The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.

Outcome measures

Measure	Priorix 1 Group n=283 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=275 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=283 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=277 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash and Varicella-like Rash. Varicella like	0 Subjects	4 Subjects	0 Subjects	0 Subjects
Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash and Varicella-like Rash. Measles/Rubella like	6 Subjects	7 Subjects	5 Subjects	5 Subjects

SECONDARY outcome

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

Population: The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.

Timing of febrile convulsions: events occured on Day 29 in the Priorix 2 Group and Day 0 in the MMR II Group. All cases of febrile convulsions were case of meningism.

Outcome measures

Measure	Priorix 1 Group n=283 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=275 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=283 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=277 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Number of Subjects Reporting Febrile Convulsions	0 Subjects	1 Subjects	0 Subjects	1 Subjects

SECONDARY outcome

Timeframe: At 1 year post-vaccination

Population: The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.

Antibody titers were expressed as Geometric Mean Titer (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody titer < 24 ED50 prior to vaccination.

Outcome measures

Measure	Priorix 1 Group n=189 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=186 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=189 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=183 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Anti-mumps Virus Antibody Titers (Enhanced Plaque Reduction Neutralization (PRN))	162.8 Titers Interval 141.8 to 186.9	188.3 Titers Interval 162.4 to 218.3	176.2 Titers Interval 152.6 to 203.3	185.5 Titers Interval 163.5 to 210.6

SECONDARY outcome

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

Population: The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.

Other rash = not confirmed by the investigator to be either measles/rubella-like or varicella-like in nature

Outcome measures

Measure	Priorix 1 Group n=283 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=275 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=283 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=277 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Number of Subjects Reporting Other Rash. Localized or generalized	72 Subjects	74 Subjects	60 Subjects	60 Subjects
Number of Subjects Reporting Other Rash. With fever	26 Subjects	29 Subjects	23 Subjects	23 Subjects
Number of Subjects Reporting Other Rash. Grade 3	11 Subjects	10 Subjects	6 Subjects	6 Subjects
Number of Subjects Reporting Other Rash. Related	9 Subjects	14 Subjects	6 Subjects	6 Subjects

SECONDARY outcome

Timeframe: At 1 year post-vaccination

Population: The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.

Anti-mumps virus antibody cut-off-value assessed was ≥ 51 ED50.

Outcome measures

Measure	Priorix 1 Group n=189 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=186 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=189 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=183 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Enhanced PRN)	169 Subjects	170 Subjects	171 Subjects	170 Subjects

SECONDARY outcome

Timeframe: At 1 year post-vaccination

Population: The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.

Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.

Outcome measures

Measure	Priorix 1 Group n=213 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=214 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=218 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=210 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.	212 Subjects	213 Subjects	217 Subjects	210 Subjects

SECONDARY outcome

Timeframe: At 2 years post-vaccination

Population: The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.

Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL).

Outcome measures

Measure	Priorix 1 Group n=171 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=158 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=168 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=166 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.	171 Subjects	158 Subjects	168 Subjects	166 Subjects

SECONDARY outcome

Timeframe: At 1 year post-vaccination

Population: The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.

Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.

Outcome measures

Measure	Priorix 1 Group n=213 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=214 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=218 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=210 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Anti-rubella Virus Antibody Concentrations	138.1 IU/mL Interval 125.3 to 152.2	145.4 IU/mL Interval 132.0 to 160.1	136.5 IU/mL Interval 123.5 to 150.9	166.8 IU/mL Interval 151.5 to 183.6

SECONDARY outcome

Timeframe: At 2 years post-vaccination

Population: The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.

Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.

Outcome measures

Measure	Priorix 1 Group n=171 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=158 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=168 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=166 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Anti-rubella Virus Antibody Concentrations	78.0 IU/mL Interval 69.7 to 87.2	79.5 IU/mL Interval 71.7 to 88.2	81.7 IU/mL Interval 73.8 to 90.4	93.1 IU/mL Interval 83.6 to 103.6

SECONDARY outcome

Timeframe: During the 15-day (Days 0-14) and 43 days (Days 0-42) post-vaccination period

Population: The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.

fever is assessed for temperature ≥38°C/100.4°F and >39.5°C/103.1°F as measured rectally.

Outcome measures

Measure	Priorix 1 Group n=283 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=275 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=283 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=277 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Number of Subjects Reporting Fever. Day 15 (N= 283; 275; 283; 277) ≥38.0°C	65 Subjects	79 Subjects	64 Subjects	56 Subjects
Number of Subjects Reporting Fever. Day 15 (N= 283; 275; 283; 277) >39.5°C	10 Subjects	7 Subjects	9 Subjects	8 Subjects
Number of Subjects Reporting Fever. Day 43 (N= 283; 275; 283; 277) ≥38.0°C	103 Subjects	104 Subjects	104 Subjects	85 Subjects
Number of Subjects Reporting Fever. Day 43 (N= 283; 275; 283; 277) >39.5°C	20 Subjects	14 Subjects	18 Subjects	13 Subjects

SECONDARY outcome

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

Population: The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.

Solicited local symptoms assessed were pain, redness and swelling.

Outcome measures

Measure	Priorix 1 Group n=282 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=274 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=282 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=274 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Number of Subjects With Solicited Local Symptoms. Pain	70 Subjects	70 Subjects	79 Subjects	67 Subjects
Number of Subjects With Solicited Local Symptoms. Redness	45 Subjects	47 Subjects	41 Subjects	47 Subjects
Number of Subjects With Solicited Local Symptoms. Swelling	20 Subjects	26 Subjects	19 Subjects	15 Subjects

SECONDARY outcome

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

Population: The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.

MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.

Outcome measures

Measure	Priorix 1 Group n=304 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=304 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=304 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=308 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Number of Subjects Reporting Medically Attended Visit (MAEs)	99 Subjects	99 Subjects	97 Subjects	107 Subjects

SECONDARY outcome

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

Population: The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.

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

Outcome measures

Measure	Priorix 1 Group n=304 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=304 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=304 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=308 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Number of Subjects With Unsolicited Adverse Events (AEs).	170 Subjects	153 Subjects	164 Subjects	169 Subjects

SECONDARY outcome

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

Population: The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.

Swelling with accompanying general symptoms

Outcome measures

Measure	Priorix 1 Group n=283 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=275 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=283 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=277 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling.	3 Subjects	3 Subjects	5 Subjects	2 Subjects

SECONDARY outcome

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

Population: The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.

Assessed solicited general symptoms were drowsiness, irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.

Outcome measures

Measure	Priorix 1 Group n=283 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=275 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=283 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=277 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Number of Subjects With Solicited General Symptoms. Any irritability	180 Subjects	141 Subjects	150 Subjects	153 Subjects
Number of Subjects With Solicited General Symptoms. Any drowsiness	133 Subjects	106 Subjects	113 Subjects	109 Subjects
Number of Subjects With Solicited General Symptoms. Any loss of appetite	111 Subjects	77 Subjects	110 Subjects	94 Subjects

SECONDARY outcome

Timeframe: From Day 0 to Day 180 after vaccination

Population: The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.

NOCIs included autoimmune disorders, asthma, type I diabetes, allergies.

Outcome measures

Measure	Priorix 1 Group n=304 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=304 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=304 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=308 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Number of Subjects Reporting New Onset Chronic Illnesses (NOCIs).	5 Subjects	2 Subjects	4 Subjects	2 Subjects

SECONDARY outcome

Timeframe: From Day 0 to Day 180 after vaccination

Population: The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

Outcome measures

Measure	Priorix 1 Group n=304 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=304 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=304 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=308 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Number of Subjects Reporting Serious Adverse Events (SAEs)	1 Subjects	6 Subjects	7 Subjects	9 Subjects

SECONDARY outcome

Timeframe: From Day 180 to Day 730 after vaccination

Population: The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are congenital anomaly/birth defect in the offspring of a study subject.

Outcome measures

Measure	Priorix 1 Group n=304 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=304 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=304 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=308 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Number of Subjects Reporting Serious Adverse Events (SAEs).	0 Subjects	0 Subjects	0 Subjects	1 Subjects

SECONDARY outcome

Timeframe: From Day 0 to Day 180 after vaccination

Population: The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.

Outcome measures

Measure	Priorix 1 Group n=304 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=304 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=304 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=308 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Number of Subjects Reporting Conditions Prompting Emergency Room (ER) Visits.	27 Subjects	28 Subjects	22 Subjects	26 Subjects

SECONDARY outcome

Timeframe: At 1 year post-vaccination

Population: The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.

Antibody titers were expressed as Geometric Mean Titer (GMT).

Outcome measures

Measure	Priorix 1 Group n=196 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=205 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=211 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=195 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Anti-mumps Virus Antibody Titers (Unenhanced PRN)	31.0 Titer Interval 24.1 to 39.9	46.1 Titer Interval 36.2 to 58.7	39.3 Titer Interval 31.0 to 50.0	46.6 Titer Interval 36.6 to 59.3

SECONDARY outcome

Timeframe: At 1 year post-vaccination

Population: The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.

Anti-mumps virus antibody cut-off-value assessed was ≥ 4 Estimated Dose 50 (ED50).

Outcome measures

Measure	Priorix 1 Group n=196 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=205 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=211 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=195 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN)	173 Subjects	186 Subjects	184 Subjects	173 Subjects

SECONDARY outcome

Timeframe: At 2 years post-vaccination

Population: The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.

Antibody concentrations are expressed as Geometric Mean Titer (GMT).

Outcome measures

Measure	Priorix 1 Group n=157 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=144 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=157 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=152 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Anti-mumps Virus Antibody Titers (Unenhanced PRN)	43.4 Titer Interval 33.4 to 56.3	48.9 Titer Interval 37.7 to 63.5	57.4 Titer Interval 45.7 to 72.2	60.7 Titer Interval 47.6 to 77.5

SECONDARY outcome

Timeframe: At 2 years post-vaccination

Population: The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.

Anti-mumps virus antibody cut-off-value assessed was ≥ 4 Estimated Dose 50 (ED50).

Outcome measures

Measure	Priorix 1 Group n=157 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=144 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=157 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=152 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN)	144 Subjects	134 Subjects	152 Subjects	144 Subjects

SECONDARY outcome

Timeframe: At 1 year post-vaccination

Population: The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.

Antibody concentrations are expressed as Geometric Mean Concentrations (GMC) in ELISA units per milliliter (EU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <5 EU/mL prior to vaccination.

Outcome measures

Measure	Priorix 1 Group n=170 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=173 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=179 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=170 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Anti-mumps Virus Antibody Concentrations (Pharmaceutical Product Development (PPD) ELISA)	47.3 EU/mL Interval 39.2 to 57.1	42.9 EU/mL Interval 36.4 to 50.6	42.5 EU/mL Interval 35.9 to 50.3	58.6 EU/mL Interval 50.6 to 67.8

SECONDARY outcome

Timeframe: At 1 year post-vaccination

Population: The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.

Anti-mumps virus antibody cut-off-value assessed was ≥ 10 ELISA units per milliliter (EU/mL)

Outcome measures

Measure	Priorix 1 Group n=170 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=173 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=179 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=170 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA)	155 Subjects	159 Subjects	162 Subjects	164 Subjects

SECONDARY outcome

Timeframe: At 2 years post-vaccination

Population: The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.

Antibody concentrations are expressed as Geometric Mean Concentrations (GMC) in ELISA units per milliliter (EU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <5 EU/mL prior to vaccination.

Outcome measures

Measure	Priorix 1 Group n=136 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=130 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=141 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=140 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Anti-mumps Virus Antibody Concentrations (PPD ELISA)	47.8 EU/mL Interval 40.2 to 56.9	50.2 EU/mL Interval 42.1 to 59.9	54.0 EU/mL Interval 46.1 to 63.3	59.2 EU/mL Interval 50.1 to 70.0

SECONDARY outcome

Timeframe: At 2 years post-vaccination

Population: The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.

Anti-mumps virus antibody cut-off-value assessed was ≥ 10 ELISA units per milliliter (EU/mL)

Outcome measures

Measure	Priorix 1 Group n=136 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=130 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=141 Participants Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=140 Participants Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA)	128 Subjects	125 Subjects	136 Subjects	134 Subjects

Adverse Events

Priorix 1 Group

Serious events: 1 serious events

Other events: 240 other events

Deaths: 0 deaths

Priorix 2 Group

Serious events: 7 serious events

Other events: 216 other events

Deaths: 0 deaths

Priorix 3 Group

Serious events: 8 serious events

Other events: 219 other events

Deaths: 0 deaths

MMR-II Group

Serious events: 10 serious events

Other events: 221 other events

Deaths: 0 deaths

Serious adverse events

Measure	Priorix 1 Group n=304 participants at risk Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=304 participants at risk Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=304 participants at risk Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=308 participants at risk Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Infections and infestations Bronchiolitis	0.33% 1/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.65% 2/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Bronchitis	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
General disorders Hypoxia	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.65% 2/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Pneumonia	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Cellulitis	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Coxsackie viral infection	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Croup infectious	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Vascular disorders Extremity necrosis	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Nervous system disorders Febrile convulsion	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Gastroenteritis viral	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations H1N1 influenza	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Blood and lymphatic system disorders Idiopathic thrombocytopenic purpura	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Influenza	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
General disorders Inflenza like illness	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Gastrointestinal disorders Intussusception	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Otitis media acute	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Pharyngotonsillitis	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Pneumonia respiratory syncytial viral	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
General disorders Pyrexia	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Rash	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Respiratory syncitial virus infection	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Staphylococcal infection	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Upper respiratory tract infection	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Urinary tract infection	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Musculoskeletal and connective tissue disorders Ataxia	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
General disorders Influenza like illness	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Nervous system disorders Ataxia	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.65% 2/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Skin and subcutaneous tissue disorders Rash	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nephroblastoma	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.

Other adverse events

Measure	Priorix 1 Group n=304 participants at risk Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 2 Group n=304 participants at risk Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	Priorix 3 Group n=304 participants at risk Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.	MMR-II Group n=308 participants at risk Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Gastrointestinal disorders Abdominal distension	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Abscess	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Acarodermatitis	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Injury, poisoning and procedural complications Accidental exposure to product by child	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Acute sinusitis	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Acute tonsillitis	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Respiratory, thoracic and mediastinal disorders Adenoidal hypertrophy	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Psychiatric disorders Aggression	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Blood and lymphatic system disorders Anaemia	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.65% 2/308 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Gastrointestinal disorders Aphthous stomatitis	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Injury, poisoning and procedural complications Arthropod bite	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.66% 2/304 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.65% 2/308 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Injury, poisoning and procedural complications Arthropod sting	0.66% 2/304 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Respiratory, thoracic and mediastinal disorders Asthma	0.99% 3/304 • Number of events 3 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.66% 2/304 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Ear and labyrinth disorders Auricular pseudocyst	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Bacteraemia	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Investigations Bacterial test negative	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Skin and subcutaneous tissue disorders Blister	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Investigations Blood iron decreased	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Body tinea	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Gastrointestinal disorders Bowel movement irregularity	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.66% 2/304 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.99% 3/304 • Number of events 3 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	1.3% 4/308 • Number of events 4 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Bronchiolitis	0.99% 3/304 • Number of events 3 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.66% 2/304 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	1.6% 5/308 • Number of events 5 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Bronchitis	0.66% 2/304 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.97% 3/308 • Number of events 3 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Bronchitis viral	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Injury, poisoning and procedural complications Burns second degree	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Candidiasis	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.65% 2/308 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Investigations Cardiac murmur	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Cellulitis	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.66% 2/304 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Ear and labyrinth disorders Cerumen impaction	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.66% 2/304 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.65% 2/308 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
General disorders Chest discomfort	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Gastrointestinal disorders Colitis	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Injury, poisoning and procedural complications Concussion	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Eye disorders Conjunctivitis	3.0% 9/304 • Number of events 9 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.99% 3/304 • Number of events 3 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	1.3% 4/308 • Number of events 4 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Conjunctivitis infective	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Gastrointestinal disorders Constipation	0.99% 3/304 • Number of events 3 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	1.3% 4/304 • Number of events 5 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.97% 3/308 • Number of events 3 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Injury, poisoning and procedural complications Contusion	1.3% 4/304 • Number of events 4 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Injury, poisoning and procedural complications Corneal abrasion	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Respiratory, thoracic and mediastinal disorders Cough	8.2% 25/304 • Number of events 28 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	6.9% 21/304 • Number of events 24 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	5.3% 16/304 • Number of events 17 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	6.2% 19/308 • Number of events 19 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Croup infectious	1.3% 4/304 • Number of events 5 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.99% 3/304 • Number of events 3 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	2.0% 6/304 • Number of events 6 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.97% 3/308 • Number of events 3 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
General disorders Crying	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Eye disorders Dark circles under eyes	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Metabolism and nutrition disorders Decreased appetite	36.5% 111/304 • Number of events 112 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	25.3% 77/304 • Number of events 78 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	36.2% 110/304 • Number of events 111 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	30.8% 95/308 • Number of events 96 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Metabolism and nutrition disorders Dehydration	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Skin and subcutaneous tissue disorders Dermatitis diaper	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Gastrointestinal disorders Diarrhoea	8.2% 25/304 • Number of events 29 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	7.9% 24/304 • Number of events 29 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	6.2% 19/304 • Number of events 21 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	6.8% 21/308 • Number of events 22 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Gastrointestinal disorders Diarrhoea haemorrhagic	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
General disorders Discomfort	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Nervous system disorders Dizziness	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Nervous system disorders Drooling	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Gastrointestinal disorders Dysphagia	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Ear infection	0.99% 3/304 • Number of events 3 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.97% 3/308 • Number of events 3 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Ear and labyrinth disorders Ear pain	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.99% 3/304 • Number of events 3 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.65% 2/308 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Skin and subcutaneous tissue disorders Eczema	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Gastrointestinal disorders Enteritis	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Enterovirus infection	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Skin and subcutaneous tissue disorders Erythema	15.1% 46/304 • Number of events 46 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	15.8% 48/304 • Number of events 49 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	14.1% 43/304 • Number of events 43 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	15.9% 49/308 • Number of events 49 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Ear and labyrinth disorders Eustachian tube dysfunction	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Injury, poisoning and procedural complications Excoriation	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Eye disorders Eye allergy	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Eye disorders Eye swelling	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Gastrointestinal disorders Faeces discoloured	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Injury, poisoning and procedural complications Fall	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Metabolism and nutrition disorders Feeding disorder of infancy or early childhood	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Gastrointestinal disorders Flatulence	0.66% 2/304 • Number of events 3 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.66% 2/304 • Number of events 3 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.65% 2/308 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Fungal infection	0.66% 2/304 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.66% 2/304 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Gastrointestinal disorders Gastritis	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Gastroenteritis	0.66% 2/304 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	1.6% 5/304 • Number of events 5 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.66% 2/304 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	1.6% 5/308 • Number of events 5 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Gastroenteritis viral	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.66% 2/304 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Reproductive system and breast disorders Genital cyst	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Gingivitis	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Reproductive system and breast disorders Gynaecomastia	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Hand-foot-and-mouth disease	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Injury, poisoning and procedural complications Head injury	0.66% 2/304 • Number of events 3 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.66% 2/304 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.66% 2/304 • Number of events 5 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	1.6% 5/308 • Number of events 5 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Herpangina	0.66% 2/304 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Hordeolum	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.66% 2/304 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
General disorders Hyperpyrexia	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Immune system disorders Hypersensitivity	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.66% 2/304 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.65% 2/308 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Impetigo	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Respiratory, thoracic and mediastinal disorders Increased upper airway secretion	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Infected bites	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Influenza	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.99% 3/304 • Number of events 3 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.66% 2/304 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
General disorders Influenza like illness	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
General disorders Injection site bruising	0.99% 3/304 • Number of events 3 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.65% 2/308 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
General disorders Injection site erythema	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.65% 2/308 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
General disorders Injection site induration	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
General disorders Injection site mass	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
General disorders Injection site reaction	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
General disorders Injection site swelling	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.65% 2/308 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Psychiatric disorders Insomnia	0.66% 2/304 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.66% 2/304 • Number of events 3 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Psychiatric disorders Irritability	59.5% 181/304 • Number of events 185 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	46.7% 142/304 • Number of events 142 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	49.3% 150/304 • Number of events 152 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	49.7% 153/308 • Number of events 154 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Renal and urinary disorders Ketonuria	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Musculoskeletal and connective tissue disorders Knee deformity	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Injury, poisoning and procedural complications Laceration	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Eye disorders Lacrimation increased	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Metabolism and nutrition disorders Lactose intolerance	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Congenital, familial and genetic disorders Laryngomalacia	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Nervous system disorders Lethargy	0.33% 1/304 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Blood and lymphatic system disorders Leukocytosis	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Injury, poisoning and procedural complications Lip injury	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
General disorders Local swelling	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Lower respiratory tract infection	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Blood and lymphatic system disorders Lymphadenopathy	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.65% 2/308 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Psychiatric disorders Middle insomnia	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Immune system disorders Milk allergy	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Molluscum contagiosum	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Injury, poisoning and procedural complications Mouth injury	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Immune system disorders Multiple allergies	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Respiratory, thoracic and mediastinal disorders Nasal congestion	2.3% 7/304 • Number of events 8 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	4.3% 13/304 • Number of events 13 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	3.0% 9/304 • Number of events 9 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	3.2% 10/308 • Number of events 11 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Respiratory, thoracic and mediastinal disorders Nasal disorder	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Nasopharyngitis	3.3% 10/304 • Number of events 11 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	2.6% 8/304 • Number of events 9 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	4.3% 13/304 • Number of events 14 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	2.9% 9/308 • Number of events 9 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
General disorders Oedema peripheral	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Oral candidiasis	0.99% 3/304 • Number of events 3 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Oral herpes	0.66% 2/304 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.66% 2/304 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.66% 2/304 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Otitis externa	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Otitis media	8.2% 25/304 • Number of events 25 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	8.2% 25/304 • Number of events 26 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	9.5% 29/304 • Number of events 31 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	7.8% 24/308 • Number of events 26 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Otitis media acute	3.0% 9/304 • Number of events 10 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	3.3% 10/304 • Number of events 13 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	2.6% 8/304 • Number of events 8 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	1.6% 5/308 • Number of events 5 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Otitis media chronic	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
General disorders Pain	23.7% 72/304 • Number of events 72 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	23.0% 70/304 • Number of events 70 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	26.0% 79/304 • Number of events 79 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	22.1% 68/308 • Number of events 69 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Musculoskeletal and connective tissue disorders Pain in extremity	0.66% 2/304 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Vascular disorders Pallor	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Paronychia	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Reproductive system and breast disorders Penile adhesion	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Pharyngitis	3.9% 12/304 • Number of events 12 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	2.3% 7/304 • Number of events 7 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	3.3% 10/304 • Number of events 10 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	1.9% 6/308 • Number of events 6 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Pharyngitis streptococcal	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	1.3% 4/304 • Number of events 4 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.97% 3/308 • Number of events 3 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Pneumonia	0.99% 3/304 • Number of events 3 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Pneumonia bacterial	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Metabolism and nutrition disorders Polydipsia	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Gastrointestinal disorders Proctalgia	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
General disorders Pyrexia	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Skin and subcutaneous tissue disorders Rash	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Skin and subcutaneous tissue disorders Rash macular	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Respiratory syncytial virus bronchitis	0.66% 2/304 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Rhinitis	2.3% 7/304 • Number of events 7 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	1.3% 4/304 • Number of events 5 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	2.0% 6/304 • Number of events 8 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	1.3% 4/308 • Number of events 4 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	7.2% 22/304 • Number of events 27 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	5.6% 17/304 • Number of events 22 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	6.9% 21/304 • Number of events 25 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	4.2% 13/308 • Number of events 13 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Immune system disorders Seasonal allergy	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Skin and subcutaneous tissue disorders Seborrhoea	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Surgical and medical procedures Sinus operation	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Sinusitis	0.99% 3/304 • Number of events 3 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	1.6% 5/304 • Number of events 5 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	1.3% 4/304 • Number of events 5 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.97% 3/308 • Number of events 3 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Skin and subcutaneous tissue disorders Skin discolouration	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Skin infection	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Nervous system disorders Somnolence	43.8% 133/304 • Number of events 133 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	34.9% 106/304 • Number of events 106 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	37.2% 113/304 • Number of events 114 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	35.4% 109/308 • Number of events 110 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Staphylococcal infection	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Gastrointestinal disorders Stomatitis	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Streptococcal infection	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Respiratory, thoracic and mediastinal disorders Stridor	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Subcutaneous abscess	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
General disorders Swelling	7.2% 22/304 • Number of events 22 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	8.6% 26/304 • Number of events 26 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	6.6% 20/304 • Number of events 20 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	4.9% 15/308 • Number of events 15 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Gastrointestinal disorders Teething	11.5% 35/304 • Number of events 40 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	11.5% 35/304 • Number of events 41 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	12.2% 37/304 • Number of events 47 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	11.4% 35/308 • Number of events 40 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Injury, poisoning and procedural complications Thermal burn	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Gastrointestinal disorders Tongue disorder	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Injury, poisoning and procedural complications Tongue injury	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Tonsillitis	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.66% 2/304 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Gastrointestinal disorders Tooth discolouration	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.66% 2/304 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.65% 2/308 • Number of events 7 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Ear and labyrinth disorders Tympanic membrane perforation	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Upper respiratory tract infection	13.2% 40/304 • Number of events 40 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	7.2% 22/304 • Number of events 25 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	12.8% 39/304 • Number of events 40 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	14.0% 43/308 • Number of events 46 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Urinary tract infection	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
General disorders Vessel puncture site bruise	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Viral infection	2.3% 7/304 • Number of events 7 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	2.6% 8/304 • Number of events 8 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	3.0% 9/304 • Number of events 9 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	3.6% 11/308 • Number of events 11 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Viral pharyngitis	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Viral rash	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Viral upper respiratory tract infection	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.33% 1/304 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/308 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Gastrointestinal disorders Vomiting	4.3% 13/304 • Number of events 15 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	3.6% 11/304 • Number of events 13 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	4.3% 13/304 • Number of events 14 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	3.9% 12/308 • Number of events 13 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Infections and infestations Vulvovaginitis	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Respiratory, thoracic and mediastinal disorders Wheezing	0.66% 2/304 • Number of events 2 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	1.3% 4/304 • Number of events 4 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	1.3% 4/304 • Number of events 4 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.
Injury, poisoning and procedural complications Wound	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.00% 0/304 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.	0.32% 1/308 • Number of events 1 • Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730). Solicited symptoms were only assessed on subjects returning the symptom sheet.

Additional Information

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GlaxoSmithKline

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Results disclosure agreements

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

Restriction type: OTHER