Trial Outcomes & Findings for Hib-MenCY-TT Vaccine Study Compared to Licensed Hib and Meningococcal Serogroup C Conjugate Vaccines (NCT NCT00134719)

NCT ID: NCT00134719

Last Updated: 2018-07-19

Results Overview

The analysis was performed on blood samples taken from half of the subjects in the MenHibrix and ActHIB/PedvaxHib groups only. The other half of the subjects in these study groups donated a blood sample after the second vaccine dose for analysis of the corresponding secondary outcome measure.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 1104 participants
• Primary outcome timeframe: One month after the 3-dose primary vaccination course
• Results posted on: 2018-07-19

Participant Flow

Subjects were randomised at the beginning of the primary vaccination phase and kept their group assignment during the fourth dose vaccination phase. Not all subjects who completed the primary vaccination phase returned for participation in the fourth dose vaccination phase.

One subject who had a subject number allocated, was not vaccinated.

Participant milestones

Measure	MenHibrix Group Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
Primary Vaccination Phase STARTED	661	221	221
Primary Vaccination Phase COMPLETED	647	215	216
Primary Vaccination Phase NOT COMPLETED	14	6	5
Fourth Dose Vaccination Phase STARTED	625	206	204
Fourth Dose Vaccination Phase COMPLETED	623	203	203
Fourth Dose Vaccination Phase NOT COMPLETED	2	3	1

Reasons for withdrawal

Measure	MenHibrix Group Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
Primary Vaccination Phase Adverse Event	4	0	0
Primary Vaccination Phase Protocol Violation	1	0	0
Primary Vaccination Phase Withdrawal by Subject	2	3	2
Primary Vaccination Phase Lost to Follow-up	7	3	3
Fourth Dose Vaccination Phase Lost to Follow-up	1	3	1
Fourth Dose Vaccination Phase Mother just delivered a new baby	1	0	0

Baseline Characteristics

Hib-MenCY-TT Vaccine Study Compared to Licensed Hib and Meningococcal Serogroup C Conjugate Vaccines

Baseline characteristics by cohort

Measure	MenHibrix Group n=661 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=221 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=221 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	Total n=1103 Participants Total of all reporting groups
Age, Continuous	61.0 Days STANDARD_DEVIATION 7.38 • n=5 Participants	61.5 Days STANDARD_DEVIATION 7.22 • n=7 Participants	61.5 Days STANDARD_DEVIATION 7.95 • n=5 Participants	61.2 Days STANDARD_DEVIATION 7.46 • n=4 Participants
Sex: Female, Male Female	328 Participants n=5 Participants	118 Participants n=7 Participants	103 Participants n=5 Participants	549 Participants n=4 Participants
Sex: Female, Male Male	333 Participants n=5 Participants	103 Participants n=7 Participants	118 Participants n=5 Participants	554 Participants n=4 Participants

PRIMARY outcome

Timeframe: One month after the 3-dose primary vaccination course

Population: Analysis was performed on half of the subjects in the MenHibrix and ActHIB/PedvaxHib groups only, on the Primary According-to-Protocol (ATP) Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.

The analysis was performed on blood samples taken from half of the subjects in the MenHibrix and ActHIB/PedvaxHib groups only. The other half of the subjects in these study groups donated a blood sample after the second vaccine dose for analysis of the corresponding secondary outcome measure.

Outcome measures

Measure	MenHibrix Group n=265 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=90 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Concentration Greater Than or Equal to 1.0 Microgram Per Milliliter (µg/mL)	255 Participants	76 Participants	—

PRIMARY outcome

Timeframe: One month after the 3-dose primary vaccination course

Population: Analysis was performed on subjects in the MenHibrix and ActHIB + Meningitec groups only, on the Primary According-to-Protocol Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.

The analysis was performed on blood samples taken from half of the subjects in the MenHibrix and ActHIB + Meningitec groups only. The other half of the subjects in these study groups donated a blood sample after the second vaccine dose for analysis of the corresponding secondary outcome measure.

Outcome measures

Measure	MenHibrix Group n=287 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=99 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Baby Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:128	271 Participants	—	95 Participants

PRIMARY outcome

Timeframe: 42 days after the fourth dose vaccination

Population: Analysis was performed on initially seronegative subjects in the MenHibrix and ActHIB groups only, on the Fourth dose According-to-Protocol cohort for immunogenicity, including all evaluable subjects with assay result available for the blood sample taken at 42 days after the administration of the fourth vaccine dose.

The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-measles seroconversion is defined as the appearance of antibodies (i.e. concentration greater than or equal to the cut-off value of 150 milli-international units per milliliter (mIU/mL)) in the serum of subjects seronegative (below 150 mIU/mL) before vaccination.

Outcome measures

Measure	MenHibrix Group n=852 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=286 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
Number of Subjects Seroconverted for Anti-measles Antibodies	815 Participants	274 Participants	—

PRIMARY outcome

Timeframe: 42 days after the fourth dose vaccination

Population: Analysis was performed on initially seronegative subjects in the MenHibrix and ActHIB groups only, on the Fourth dose According-to-Protocol cohort for immunogenicity, including all evaluable subjects with assay result available for the blood sample taken at 42 days after the administration of the fourth vaccine dose.

The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-mumps seroconversion is defined as titer greater than or equal to 28 ED50 in subjects seronegative (<28 ED50) before vaccination.

ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent.

Outcome measures

Measure	MenHibrix Group n=601 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=191 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
Number of Subjects Seroconverted for Anti-mumps Antibodies	595 Participants	191 Participants	—

PRIMARY outcome

Timeframe: 42 days after the fourth dose vaccination

Population: Analysis was performed on initially seronegative subjects in the MenHibrix and ActHIB groups only, on the Fourth dose According-to-Protocol cohort for immunogenicity, including all evaluable subjects with assay result available for the blood sample taken at 42 days after the administration of the fourth vaccine dose.

The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-rubella seroresponse is defined as post-vaccination concentration greater than or equal to 10 IU/mL (ELISA, Enzygnost) in subjects seronegative (concentration below 4 IU/mL) before vaccination.

Outcome measures

Measure	MenHibrix Group n=850 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=285 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
Number of Subjects With an Anti-rubella Seroresponse	848 Participants	284 Participants	—

PRIMARY outcome

Timeframe: 42 days after the fourth dose vaccination

Population: Analysis was performed on initially seronegative subjects in the MenHibrix and ActHIB groups only, on the Fourth dose According-to-Protocol cohort for immunogenicity, including all evaluable subjects with assay result available for the blood sample taken at 42 days after the administration of the fourth vaccine dose.

The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-varicella seroconversion is defined as post-vaccination titers greater than or equal to 1:5, in subjects seronegative (titers below 1:5) before vaccination.

Outcome measures

Measure	MenHibrix Group n=723 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=223 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
Number of Subjects Seroconverted for Anti-varicella Antibodies	722 Participants	223 Participants	—

SECONDARY outcome

Timeframe: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)

Population: Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.

The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were titers 1:8 and 1:128.

Outcome measures

Measure	MenHibrix Group n=496 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=164 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=169 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values Post-dose 2 titer ≥ 1:8	282 Participants	2 Participants	97 Participants
Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values Post-dose 3 titer ≥ 1:8	284 Participants	5 Participants	99 Participants
Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values Pre-dose 4 titer ≥ 1:8	449 Participants	16 Participants	143 Participants
Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values Post-dose 4 titer ≥ 1:8	494 Participants	16 Participants	155 Participants
Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values Post-dose 2 titer ≥ 1:128	239 Participants	0 Participants	91 Participants
Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values Post-dose 3 titer ≥ 1:128	271 Participants	0 Participants	95 Participants
Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values Pre-dose 4 titer ≥ 1:128	241 Participants	1 Participants	50 Participants
Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values Post-dose 4 titer ≥ 1:128	482 Participants	5 Participants	115 Participants

SECONDARY outcome

Timeframe: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)

Population: Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.

The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. Titers are given as Geometric Mean Titers.

Outcome measures

Measure	MenHibrix Group n=496 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=164 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=169 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
rSBA-MenC Titers Post-dose 2	356.9 titer Interval 302.6 to 420.9	4.2 titer Interval 3.9 to 4.5	714.5 titer Interval 541.6 to 942.7
rSBA-MenC Titers Post-dose 3	804.6 titer Interval 699.9 to 924.9	4.5 titer Interval 4.0 to 5.0	790.1 titer Interval 649.4 to 961.2
rSBA-MenC Titers Pre-dose 4	102.8 titer Interval 90.1 to 117.3	5.2 titer Interval 4.6 to 5.9	53.7 titer Interval 43.0 to 67.1
rSBA-MenC Titers Post-dose 4	1696.7 titer Interval 1515.8 to 1899.2	5.4 titer Interval 4.7 to 6.2	261.9 titer Interval 204.4 to 335.7

SECONDARY outcome

Timeframe: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)

Population: Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.

The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were titers 1:8 and 1:128.

Outcome measures

Measure	MenHibrix Group n=514 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=159 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=167 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values Post-dose 2 titer ≥ 1:8	289 Participants	13 Participants	10 Participants
Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values Post-dose 3 titer ≥ 1:8	287 Participants	22 Participants	16 Participants
Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values Pre-dose 4 titer ≥ 1:8	506 Participants	42 Participants	65 Participants
Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values Post-dose 4 titer ≥ 1:8	496 Participants	90 Participants	162 Participants
Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values Post-dose 2 titer ≥ 1:128	224 Participants	3 Participants	2 Participants
Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values Post-dose 3 titer ≥ 1:128	264 Participants	5 Participants	9 Participants
Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values Pre-dose 4 titer ≥ 1:128	414 Participants	19 Participants	35 Participants
Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values Post-dose 4 titer ≥ 1:128	493 Participants	59 Participants	152 Participants

SECONDARY outcome

Timeframe: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)

Population: Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.

The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. Titers are given as Geometric Mean Titers.

Outcome measures

Measure	MenHibrix Group n=514 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=159 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=167 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
rSBA-MenY Titers Post-dose 2	315.6 Titer Interval 271.6 to 366.9	5.9 Titer Interval 4.7 to 7.3	5.4 Titer Interval 4.5 to 6.5
rSBA-MenY Titers Post-dose 3	728.3 Titer Interval 635.5 to 834.7	7.7 Titer Interval 5.9 to 10.2	7.1 Titer Interval 5.4 to 9.3
rSBA-MenY Titers Pre-dose 4	264.4 Titer Interval 240.7 to 290.4	10.5 Titer Interval 8.0 to 13.6	16.0 Titer Interval 12.0 to 21.2
rSBA-MenY Titers Post-dose 4	1986.5 Titer Interval 1825.9 to 2161.3	34.4 Titer Interval 25.2 to 47.0	797.7 Titer Interval 658.5 to 966.2

SECONDARY outcome

Timeframe: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)

Population: Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.

The analysis for was performed on the first 30% of the blood samples taken at each time point. The cut-off values assessed were titers 1:4 and 1:8.

Outcome measures

Measure	MenHibrix Group n=134 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=50 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=54 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values Post-dose 4 titer ≥ 1:8	131 Participants	1 Participants	41 Participants
Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values Post-dose 2 titer ≥ 1:4	85 Participants	0 Participants	29 Participants
Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values Post-dose 3 titer ≥ 1:4	83 Participants	0 Participants	28 Participants
Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values Pre-dose 4 titer ≥ 1:4	125 Participants	5 Participants	46 Participants
Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values Post-dose 4 titer ≥ 1:4	131 Participants	1 Participants	41 Participants
Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values Post-dose 2 titer ≥ 1:8	84 Participants	0 Participants	29 Participants
Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values Post-dose 3 titer ≥ 1:8	83 Participants	0 Participants	28 Participants
Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values Pre-dose 4 titer ≥ 1:8	125 Participants	5 Participants	46 Participants

SECONDARY outcome

Timeframe: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)

Population: Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.

The analysis for was performed on the first 30% of the blood samples taken at each time point. Titers are given as Geometric Mean Titers.

Outcome measures

Measure	MenHibrix Group n=134 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=50 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=54 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
hSBA-MenC Titers Post-dose 2	179.4 Titer Interval 130.3 to 247.1	2.0 Titer Interval 2.0 to 2.0	319.0 Titer Interval 173.6 to 586.2
hSBA-MenC Titers Post-dose 3	379.4 Titer Interval 294.6 to 488.6	2.0 Titer Interval 2.0 to 2.0	254.2 Titer Interval 192.7 to 335.4
hSBA-MenC Titers Pre-dose 4	97.7 Titer Interval 74.0 to 128.9	2.6 Titer Interval 2.0 to 3.3	34.6 Titer Interval 22.8 to 52.6
hSBA-MenC Titers Post-dose 4	1807.6 Titer Interval 1398.2 to 2336.8	2.2 Titer Interval 1.8 to 2.6	171.5 Titer Interval 94.7 to 310.8

SECONDARY outcome

Timeframe: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)

Population: Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.

The analysis for was performed on the first 30% of the blood samples taken at each time point. The cut-off values assessed were titers 1:4 and 1:8.

Outcome measures

Measure	MenHibrix Group n=122 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=41 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=44 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values Post-dose 2 titer ≥ 1:4	79 Participants	0 Participants	0 Participants
Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values Post-dose 3 titer ≥ 1:4	85 Participants	0 Participants	0 Participants
Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values Pre-dose 4 titer ≥ 1:4	104 Participants	0 Participants	1 Participants
Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values Post-dose 4 titer ≥ 1:4	119 Participants	16 Participants	15 Participants
Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values Post-dose 2 titer ≥ 1:8	73 Participants	0 Participants	0 Participants
Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values Post-dose 3 titer ≥ 1:8	85 Participants	0 Participants	0 Participants
Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values Pre-dose 4 titer ≥ 1:8	103 Participants	0 Participants	1 Participants
Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values Post-dose 4 titer ≥ 1:8	119 Participants	16 Participants	13 Participants

SECONDARY outcome

Timeframe: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)

Population: Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.

The analysis for was performed on the first 30% of the blood samples taken at each time point. Titers are given as Geometric Mean Titers.

Outcome measures

Measure	MenHibrix Group n=122 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=41 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=44 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
hSBA-MenY Titers Post-dose 2	25.6 Titer Interval 19.3 to 34.1	2.0 Titer Interval 2.0 to 2.0	2.0 Titer Interval 2.0 to 2.0
hSBA-MenY Titers Post-dose 3	86.4 Titer Interval 68.9 to 108.3	2.0 Titer Interval 2.0 to 2.0	2.0 Titer Interval 2.0 to 2.0
hSBA-MenY Titers Pre-dose 4	81.2 Titer Interval 58.6 to 112.6	2.0 Titer Interval 2.0 to 2.0	2.2 Titer Interval 1.8 to 2.7
hSBA-MenY Titers Post-dose 4	1002.2 Titer Interval 740.9 to 1355.7	18.3 Titer Interval 7.7 to 43.6	8.8 Titer Interval 4.4 to 17.3

SECONDARY outcome

Timeframe: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)

Population: Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.

The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were 0.3 µg/mL and 2 µg/mL.

Outcome measures

Measure	MenHibrix Group n=490 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=138 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=160 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values Post-dose 2 concentration ≥0.3 µg/mL	296 Participants	7 Participants	95 Participants
Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values Post-dose 3 concentration ≥0.3 µg/mL	276 Participants	3 Participants	95 Participants
Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values Pre-dose 4 concentration≥0.3 µg/mL	417 Participants	2 Participants	138 Participants
Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values Post-dose 4 concentration≥0.3µg/mL	489 Participants	1 Participants	158 Participants
Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values Post-dose 2 concentration ≥2.0 µg/mL	248 Participants	1 Participants	81 Participants
Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values Post-dose 3 concentration ≥2.0 µg/mL	241 Participants	0 Participants	79 Participants
Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values Pre-dose 4 concentration≥2.0 µg/mL	53 Participants	0 Participants	31 Participants
Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values Post-dose 4 concentration≥2.0µg/mL	408 Participants	0 Participants	95 Participants

SECONDARY outcome

Timeframe: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)

Population: Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.

The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. Concentrations are given as Geometric Mean Concentrations.

Outcome measures

Measure	MenHibrix Group n=490 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=138 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=160 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
Anti-PSC Concentrations Post-dose 2	4.32 Microgram per milliliter (µg/mL) Interval 3.98 to 4.69	0.17 Microgram per milliliter (µg/mL) Interval 0.15 to 0.19	3.54 Microgram per milliliter (µg/mL) Interval 3.08 to 4.06
Anti-PSC Concentrations Post-dose 3	4.15 Microgram per milliliter (µg/mL) Interval 3.87 to 4.46	0.16 Microgram per milliliter (µg/mL) Interval 0.15 to 0.17	3.94 Microgram per milliliter (µg/mL) Interval 3.4 to 4.55
Anti-PSC Concentrations Pre-dose 4	0.77 Microgram per milliliter (µg/mL) Interval 0.71 to 0.83	0.15 Microgram per milliliter (µg/mL) Interval 0.15 to 0.16	0.86 Microgram per milliliter (µg/mL) Interval 0.73 to 1.01
Anti-PSC Concentrations Post-dose 4	4.78 Microgram per milliliter (µg/mL) Interval 4.42 to 5.16	0.15 Microgram per milliliter (µg/mL) Interval 0.15 to 0.16	2.65 Microgram per milliliter (µg/mL) Interval 2.24 to 3.14

SECONDARY outcome

Timeframe: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)

Population: Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.

The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were 0.3 µg/mL and 2 µg/mL.

Outcome measures

Measure	MenHibrix Group n=502 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=122 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=162 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values Post-dose 2 concentration ≥0.3 µg/mL	291 Participants	6 Participants	3 Participants
Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values Post-dose 3 concentration ≥0.3 µg/mL	269 Participants	4 Participants	3 Participants
Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values Pre-dose 4 concentration≥0.3 µg/mL	469 Participants	4 Participants	2 Participants
Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values Post-dose 4 concentration≥0.3µg/mL	502 Participants	3 Participants	160 Participants
Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values Post-dose 2 concentration ≥2.0 µg/mL	268 Participants	0 Participants	0 Participants
Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values Post-dose 3 concentration ≥2.0 µg/mL	266 Participants	0 Participants	0 Participants
Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values Pre-dose 4 concentration≥2.0 µg/mL	278 Participants	2 Participants	1 Participants
Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values Post-dose 4 concentration≥2.0µg/mL	96 Participants	1 Participants	46 Participants

SECONDARY outcome

Timeframe: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)

Population: Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.

The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. Concentrations are given as Geometric Mean Concentrations.

Outcome measures

Measure	MenHibrix Group n=502 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=122 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=162 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
Anti-PSY Concentrations Post-dose 2	7.81 Microgram per milliliter (µg/mL) Interval 7.04 to 8.67	0.17 Microgram per milliliter (µg/mL) Interval 0.15 to 0.19	0.16 Microgram per milliliter (µg/mL) Interval 0.15 to 0.16
Anti-PSY Concentrations Post-dose 3	12.92 Microgram per milliliter (µg/mL) Interval 11.8 to 14.14	0.16 Microgram per milliliter (µg/mL) Interval 0.15 to 0.17	0.15 Microgram per milliliter (µg/mL) Interval 0.15 to 0.16
Anti-PSY Concentrations Pre-dose 4	2.44 Microgram per milliliter (µg/mL) Interval 2.26 to 2.64	0.16 Microgram per milliliter (µg/mL) Interval 0.15 to 0.18	0.16 Microgram per milliliter (µg/mL) Interval 0.15 to 0.16
Anti-PSY Concentrations Post-dose 4	16.92 Microgram per milliliter (µg/mL) Interval 15.6 to 18.35	0.16 Microgram per milliliter (µg/mL) Interval 0.15 to 0.17	7.09 Microgram per milliliter (µg/mL) Interval 6.05 to 8.31

SECONDARY outcome

Timeframe: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)

Population: Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.

The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were 0.15 µg/mL and 1.0 µg/mL.

Outcome measures

Measure	MenHibrix Group n=562 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=182 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=189 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values Post-dose 2 ≥ 0.15 µg/mL	255 Participants	70 Participants	77 Participants
Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values Post-dose 3 ≥ 0.15 µg/mL	265 Participants	88 Participants	85 Participants
Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values Pre-dose 4 ≥ 0.15 µg/mL	541 Participants	159 Participants	160 Participants
Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values Post-dose 4 ≥ 0.15 µg/mL	549 Participants	182 Participants	183 Participants
Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values Post-dose 2 ≥ 1.0 µg/mL	151 Participants	40 Participants	41 Participants
Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values Post-dose 3 ≥ 1.0 µg/mL	255 Participants	76 Participants	74 Participants
Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values Pre-dose 4 ≥ 1.0 µg/mL	314 Participants	74 Participants	71 Participants
Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values Post-dose 4 ≥ 1.0 µg/mL	547 Participants	179 Participants	176 Participants

SECONDARY outcome

Timeframe: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)

Population: Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.

The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. Concentrations are given as Geometric Mean Concentrations.

Outcome measures

Measure	MenHibrix Group n=562 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=182 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=189 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
Anti-PRP Concentrations Post-dose 2	1.320 Microgram per milliliter (µg/mL) Interval 1.097 to 1.588	0.861 Microgram per milliliter (µg/mL) Interval 0.607 to 1.222	0.788 Microgram per milliliter (µg/mL) Interval 0.571 to 1.089
Anti-PRP Concentrations Post-dose 3	8.551 Microgram per milliliter (µg/mL) Interval 7.502 to 9.746	5.014 Microgram per milliliter (µg/mL) Interval 3.675 to 6.841	3.692 Microgram per milliliter (µg/mL) Interval 2.747 to 4.961
Anti-PRP Concentrations Pre-dose 4	1.175 Microgram per milliliter (µg/mL) Interval 1.061 to 1.3	0.748 Microgram per milliliter (µg/mL) Interval 0.611 to 0.916	0.668 Microgram per milliliter (µg/mL) Interval 0.544 to 0.82
Anti-PRP Concentrations Post-dose 4	34.890 Microgram per milliliter (µg/mL) Interval 31.687 to 38.417	20.975 Microgram per milliliter (µg/mL) Interval 17.668 to 24.899	13.442 Microgram per milliliter (µg/mL) Interval 11.057 to 16.343

SECONDARY outcome

Timeframe: Just prior to the fourth dose and 42 days after the fourth dose

Population: Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.

The cut-off value assessed was 150 mIU/mL.

Outcome measures

Measure	MenHibrix Group n=542 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=178 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=185 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
Number of Subjects With Anti-measles Concentration Greater Than or Equal to 150 mIU/mL 42 days after the fourth dose	510 Participants	170 Participants	173 Participants
Number of Subjects With Anti-measles Concentration Greater Than or Equal to 150 mIU/mL Just prior to the fourth dose	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Just prior to the fourth dose and 42 days after the fourth dose

Population: Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.

ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent.

Outcome measures

Measure	MenHibrix Group n=509 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=165 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=170 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
Number of Subjects With Anti-mumps Titer Greater Than or Equal to 24 ED50 Just prior to the fourth dose	179 Participants	52 Participants	59 Participants
Number of Subjects With Anti-mumps Titer Greater Than or Equal to 24 ED50 42 days after the fourth dose	505 Participants	163 Participants	169 Participants

SECONDARY outcome

Timeframe: Just prior to the fourth dose and 42 days after the fourth dose

Population: Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.

The cut-off value assessed was 4 IU/mL.

Outcome measures

Measure	MenHibrix Group n=540 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=177 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=185 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
Number of Subjects With Anti-rubella Concentration Greater Than or Equal to 4 IU/mL 42 days after the fourth dose	540 Participants	177 Participants	184 Participants
Number of Subjects With Anti-rubella Concentration Greater Than or Equal to 4 IU/mL Just prior to the fourth dose	2 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Just prior to the fourth dose and 42 days after the fourth dose

Population: Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point

The cut-off value assessed was a titer of 1:5.

Outcome measures

Measure	MenHibrix Group n=548 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=179 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=184 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
Number of Subjects With Anti-varicella Titer Greater Than or Equal to 1:5 Just prior to the fourth dose	126 Participants	56 Participants	44 Participants
Number of Subjects With Anti-varicella Titer Greater Than or Equal to 1:5 42 days after the fourth dose	547 Participants	179 Participants	183 Participants

SECONDARY outcome

Timeframe: 42 days after the fourth dose

Population: Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.

Fourth dose response for hSBA-MenC is defined as: •For initially seronegative subjects (i.e., subjects with pre fourth dose hSBA antibody titer below 1:4), post fourth dose hSBA antibody titer greater than or equal to 1:16; •For initially seropositive subjects (i.e., subjects with pre fourth dose antibody titer greater than or equal to 1:4), post fourth dose hSBA antibody titer greater than or equal to 1:128.

Outcome measures

Measure	MenHibrix Group n=103 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=40 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=36 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
Number of Subjects With a Fourth Dose Response for hSBA-MenC	100 Participants	1 Participants	23 Participants

SECONDARY outcome

Timeframe: 42 days after the fourth dose

Population: Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.

Fourth dose response for hSBA-MenY defined as: •For initially seronegative subjects (i.e., pre fourth dose hSBA antibody titer < 1:4), post fourth dose hSBA antibody titer greater than or equal to (≥) 1:16; •For initially seropositive subjects with pre fourth dose hSBA antibody titer ≥ 1:4 and < 1:64, post fourth dose hSBA antibody titer at least 4-fold higher than the pre fourth dose hSBA antibody titer; •For initially seropositive subjects with pre fourth dose hSBA antibody titer ≥ 1:64, post fourth dose hSBA antibody titer at least 2-fold higher than the pre fourth dose hSBA antibody titer.

Outcome measures

Measure	MenHibrix Group n=81 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=29 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=23 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
Number of Subjects With a Fourth Dose Response for hSBA-MenY	75 Participants	16 Participants	6 Participants

SECONDARY outcome

Timeframe: 42 days after the fourth dose

Population: Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.

The pre-defined cut-off values were 150 mIU/mL and 200 mIU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-measles concentration below 150 mIU/mL.

Outcome measures

Measure	MenHibrix Group n=501 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=171 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=173 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
Number of Subjects With Anti-measles Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects Greater than or equal to 150 mIU/mL	469 Participants	163 Participants	164 Participants
Number of Subjects With Anti-measles Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects Greater than or equal to 200 mIU/mL	466 Participants	162 Participants	163 Participants

SECONDARY outcome

Timeframe: 42 days after the fourth dose

Population: Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.

Concentrations are presented as Geometric Mean Concentrations expressed as mIU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-measles concentration below 150 mIU/mL.

Outcome measures

Measure	MenHibrix Group n=501 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=171 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=173 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
Anti-measles Concentrations in Initially Seronegative Subjects	1627.494 Milli-International Units per Milliliter Interval 1469.996 to 1801.866	1786.404 Milli-International Units per Milliliter Interval 1523.083 to 2095.25	1773.293 Milli-International Units per Milliliter Interval 1500.779 to 2095.292

SECONDARY outcome

Timeframe: 42 days after the fourth dose

Population: Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.

The pre-defined cut-off values were 4 IU/mL and 10 IU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-measles concentration below 4 IU/mL.

Outcome measures

Measure	MenHibrix Group n=500 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=171 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=174 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
Number of Subjects With Anti-rubella Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects ≥ 4 International Units per Milliliter	500 Participants	171 Participants	174 Participants
Number of Subjects With Anti-rubella Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects ≥ 10 International Units per Milliliter	498 Participants	171 Participants	173 Participants

SECONDARY outcome

Timeframe: 42 days after the fourth dose

Population: Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.

Concentrations are presented as Geometric Mean Concentrations expressed as IU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-rubella concentration below 4 IU/mL.

Outcome measures

Measure	MenHibrix Group n=500 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=171 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=174 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
Anti-rubella Concentrations in Initially Seronegative Subjects	78.779 International Units per Milliliter Interval 73.941 to 83.932	76.691 International Units per Milliliter Interval 69.019 to 85.217	83.168 International Units per Milliliter Interval 74.535 to 92.801

SECONDARY outcome

Timeframe: 42 days after the fourth dose

Population: Analysis was performed on subjects with a pre-vaccination anti-mumps titer below 28 ED50 in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.

ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent.

Outcome measures

Measure	MenHibrix Group n=332 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=110 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=115 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
Number of Subjects With Anti-mumps Titer Greater Than or Equal to 28 ED50 in Subjects With Anti-mumps Titer Below 28 ED50 Before Vaccination	330 Participants	110 Participants	115 Participants

SECONDARY outcome

Timeframe: 42 days after the fourth dose

Population: Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.

The pre-defined cut-off values were 28 ED50 and 51 ED50. Initially seronegative subjects are defined as subjects with pre-vaccination anti-mumps titer below 24 ED50.

Outcome measures

Measure	MenHibrix Group n=293 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=102 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=98 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
Number of Subjects With Anti-mumps Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects Greater than or equal to 28 ED50	293 Participants	102 Participants	98 Participants
Number of Subjects With Anti-mumps Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects Greater than or equal to 51 ED50	265 Participants	93 Participants	92 Participants

SECONDARY outcome

Timeframe: 42 days after the fourth dose

Population: Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.

Titers are presented as Geometric Mean Titers expressed as ED50, the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent. Initially seronegative subjects are defined as subjects with pre-vaccination anti-mumps titer below 24 ED50.

Outcome measures

Measure	MenHibrix Group n=293 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=102 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=98 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
Anti-mumps Titers in Initially Seronegative Subjects	120.777 Titer Interval 111.967 to 130.281	115.279 Titer Interval 101.835 to 130.498	145.405 Titer Interval 128.318 to 164.766

SECONDARY outcome

Timeframe: 42 days after the fourth dose

Population: Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.

The pre-defined cut-off values were 1:5 and 1:40. Initially seronegative subjects are defined as subjects with pre-vaccination anti-varicella titer below 1:5.

Outcome measures

Measure	MenHibrix Group n=404 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=119 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=136 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
Number of Subjects With Anti-varicella Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects Titer greater than or equal to 1:5	403 Participants	119 Participants	136 Participants
Number of Subjects With Anti-varicella Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects Titer greater than or equal to 1:40	403 Participants	119 Participants	136 Participants

SECONDARY outcome

Timeframe: 42 days after the fourth dose

Population: Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.

Titers are presented as Geometric Mean Titers. Initially seronegative subjects are defined as subjects with pre-vaccination anti-varicella titer below 1:5.

Outcome measures

Measure	MenHibrix Group n=404 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=119 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=136 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
Anti-varicella Titers in Initially Seronegative Subjects	414.633 Titer Interval 391.361 to 439.288	438.280 Titer Interval 394.261 to 487.214	468.985 Titer Interval 421.845 to 521.393

SECONDARY outcome

Timeframe: During a 4-day period (Day 0-3) after any vaccine dose in the primary vaccination phase

Population: Analysis was performed on all subjects with an available symptom sheet in the Primary Total Vaccinated Cohort, including all subjects vaccinated during the primary vaccination phase.

Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever (rectal temperature greater than or equal to 38 degrees Celcius), irritability and loss of appetite.

Outcome measures

Measure	MenHibrix Group n=659 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=220 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=220 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase Pain	432 Participants	152 Participants	171 Participants
Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase Redness	556 Participants	189 Participants	189 Participants
Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase Swelling	492 Participants	167 Participants	163 Participants
Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase Drowsiness	530 Participants	176 Participants	193 Participants
Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase Fever	196 Participants	80 Participants	83 Participants
Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase Irritability	616 Participants	212 Participants	211 Participants
Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase Loss of appetite	410 Participants	135 Participants	153 Participants

SECONDARY outcome

Timeframe: During a 4-day period (Day 0-3) after the fourth dose vaccination phase

Population: Analysis was performed on all subjects with an available symptom sheet in the Fourth Dose Total Vaccinated Cohort, including all subjects vaccinated during the fourth dose vaccination phase.

Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever (rectal temperature greater than or equal to 38 degrees Celcius), irritability and loss of appetite.

Outcome measures

Measure	MenHibrix Group n=622 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=201 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=202 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase Pain	217 Participants	100 Participants	60 Participants
Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase Redness	379 Participants	157 Participants	102 Participants
Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase Swelling	225 Participants	123 Participants	63 Participants
Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase Drowsiness	196 Participants	71 Participants	63 Participants
Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase Fever	60 Participants	31 Participants	14 Participants
Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase Irritability	361 Participants	117 Participants	120 Participants
Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase Loss of appetite	224 Participants	62 Participants	76 Participants

SECONDARY outcome

Timeframe: During the 31-day (Day 0-30) post-primary and post-fourth dose vaccination period

Population: Analysis was performed on the Primary Total Vaccinated Cohort and the Fourth Dose Total Vaccinated Cohort, including all subjects vaccinated during the primary and fourth dose vaccination phases, respectively.

Unsolicited adverse event covers any adverse event 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.

Outcome measures

Measure	MenHibrix Group n=661 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=221 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=221 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
Number of Subjects Reporting Unsolicited Adverse Events Post-primary vaccination period	490 Participants	158 Participants	166 Participants
Number of Subjects Reporting Unsolicited Adverse Events Post-fourth dose vaccination period	429 Participants	147 Participants	139 Participants

SECONDARY outcome

Timeframe: During a 43-day (Day 0-42) after the fourth dose

Population: Analysis was performed on the Primary Total Vaccinated Cohort and the Fourth Dose Total Vaccinated Cohort, including all subjects vaccinated during the primary and fourth dose vaccination phases, respectively.

Specific solicited general symptoms assessed include fever (temperature greater than or equal to 38 degrees Celcius), meningismus/ febrile convulsion, parotid / salivary gland swelling and rash.

Outcome measures

Measure	MenHibrix Group n=622 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=201 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=202 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
Number of Subjects Reporting Specific Solicited General AEs Related to Measles, Mumps, Rubella Vaccine and Varicella Vaccine Fever	324 Participants	112 Participants	107 Participants
Number of Subjects Reporting Specific Solicited General AEs Related to Measles, Mumps, Rubella Vaccine and Varicella Vaccine Meningismus/ febrile convulsion	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Specific Solicited General AEs Related to Measles, Mumps, Rubella Vaccine and Varicella Vaccine Parotid / salivary gland swelling	4 Participants	0 Participants	1 Participants
Number of Subjects Reporting Specific Solicited General AEs Related to Measles, Mumps, Rubella Vaccine and Varicella Vaccine Rash	232 Participants	66 Participants	86 Participants

SECONDARY outcome

Timeframe: From enrolment through the day preceding the fourth dose

Population: Analysis was performed on the Primary Total Vaccinated Cohort, including all subjects vaccinated during the primary vaccination phase.

SAEs: 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. NOCI: e.g. autoimmune disorders, asthma, type I diabetes and allergies. Types of rash: hives, idiopathic thrombocytopenic purpura and petechiae. ER and PO visits assessed were not related to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infection, otitis media, pharyngitis and gastroenteritis.

Outcome measures

Measure	MenHibrix Group n=661 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=221 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=221 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Primary Vaccination Phase Rash	176 Participants	51 Participants	67 Participants
Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Primary Vaccination Phase New onset of chronic illnesses	124 Participants	36 Participants	39 Participants
Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Primary Vaccination Phase Emergency room visits	81 Participants	14 Participants	22 Participants
Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Primary Vaccination Phase Physician office visits	291 Participants	88 Participants	90 Participants
Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Primary Vaccination Phase Serious adverse events	55 Participants	15 Participants	21 Participants

SECONDARY outcome

Timeframe: From the day of administration of the fourth dose until the end of the extended safety follow-up period (last study contact at 18-21 months of age

Population: Analysis was performed on the Fourth Dose Total Vaccinated Cohort, including all subjects vaccinated during the ourth dose vaccination phase.

SAEs: 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. NOCI: e.g. autoimmune disorders, asthma, type I diabetes and allergies. Types of rash: hives, idiopathic thrombocytopenic purpura and petechiae. ER and PO visits assessed were not related to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infection, otitis media, pharyngitis and gastroenteritis.

Outcome measures

Measure	MenHibrix Group n=625 Participants Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=204 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=206 Participants Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Fourth Dose Vaccination Phase Rash	52 Participants	13 Participants	15 Participants
Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Fourth Dose Vaccination Phase New onset of chronic illnesses	20 Participants	5 Participants	8 Participants
Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Fourth Dose Vaccination Phase Emergency room visits	42 Participants	10 Participants	13 Participants
Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Fourth Dose Vaccination Phase Physician office visits	220 Participants	63 Participants	64 Participants
Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Fourth Dose Vaccination Phase Serious adverse events	40 Participants	8 Participants	12 Participants

Adverse Events

MenHibrix Group

Serious events: 55 serious events

Other events: 657 other events

Deaths: 0 deaths

ActHIB + Meningitec Group

Serious events: 21 serious events

Other events: 220 other events

Deaths: 0 deaths

ActHIB/PedvaxHIB Group

Serious events: 15 serious events

Other events: 220 other events

Deaths: 0 deaths

Serious adverse events

Measure	MenHibrix Group n=661 participants at risk Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=221 participants at risk Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=221 participants at risk Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
Cardiac disorders Cyanosis	0.15% 1/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Cardiac disorders Hypertrophic cardiomyopathy	0.00% 0/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.45% 1/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Congenital, familial and genetic disorders Cryptorchism	0.00% 0/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.45% 1/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Congenital, familial and genetic disorders Dermoid cyst	0.00% 0/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.45% 1/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Congenital, familial and genetic disorders Respiratory tract malformation	0.15% 1/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Gastrointestinal disorders Anal fistula	0.15% 1/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.15% 1/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Gastrointestinal disorders Inguinal hernia	0.00% 0/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.45% 1/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Gastrointestinal disorders Vomiting	0.15% 1/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.45% 1/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Immune system disorders Food allergy	0.15% 1/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.45% 1/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Infections and infestations Bronchiolitis	0.16% 1/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.98% 2/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Infections and infestations Campylobacter gastroenteritis	0.15% 1/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Infections and infestations Croup infectious	0.32% 2/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Infections and infestations Escherichia urinary tract infection	0.30% 2/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Infections and infestations Exanthema subitum	0.15% 1/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Infections and infestations Gastroenteritis	1.8% 11/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.49% 1/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Infections and infestations Herpes virus infection	0.15% 1/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Infections and infestations Lobar pneumonia	0.15% 1/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Infections and infestations Otitis media	1.3% 8/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.49% 1/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Infections and infestations Otitis media chronic	0.00% 0/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.49% 1/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Infections and infestations Perianal abscess	0.15% 1/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Infections and infestations Pneumonia	0.30% 2/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.45% 1/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.45% 1/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Infections and infestations Pneumonia mycoplasmal	0.15% 1/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Infections and infestations Pneumonia primary atypical	0.00% 0/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.45% 1/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Infections and infestations Pneumonia viral	0.16% 1/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.49% 1/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Infections and infestations Respiratory syncytial virus bronchiolitis	0.00% 0/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	1.5% 3/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.49% 1/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Infections and infestations Sepsis	0.15% 1/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.45% 1/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Infections and infestations Staphylococcal sepsis	0.00% 0/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.45% 1/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Infections and infestations Tonsillitis	0.32% 2/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Infections and infestations Upper respiratory tract infection	0.16% 1/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.49% 1/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Infections and infestations Urinary tract infection	0.00% 0/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.49% 1/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Infections and infestations Viral infection	0.16% 1/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.45% 1/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Injury, poisoning and procedural complications Head injury	0.15% 1/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.45% 1/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Injury, poisoning and procedural complications Skull fracture	0.15% 1/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.45% 1/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Investigations Investigation	0.00% 0/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.45% 1/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Metabolism and nutrition disorders Dehydration	0.16% 1/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.15% 1/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Nervous system disorders Epilepsy	0.15% 1/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Nervous system disorders Febrile convulsion	0.32% 2/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.49% 1/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Nervous system disorders Hypotonic-hyporesponsive episode	0.15% 1/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Nervous system disorders Infantile spasms	0.00% 0/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.45% 1/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Psychiatric disorders Breath holding	0.15% 1/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Renal and urinary disorders Vesicoureteric reflux	0.15% 1/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Respiratory, thoracic and mediastinal disorders Asthma	0.64% 4/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.49% 1/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Musculoskeletal and connective tissue disorders Joint effusion	0.16% 1/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute lymphocytic leukaemia	0.16% 1/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.16% 1/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.49% 1/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Respiratory, thoracic and mediastinal disorders Wheezing	0.48% 3/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.49% 1/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Respiratory, thoracic and mediastinal disorders Laryngospasm	0.00% 0/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.45% 1/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.15% 1/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Skin and subcutaneous tissue disorders Dermatitis	0.15% 1/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Skin and subcutaneous tissue disorders Urticaria	0.15% 1/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Cardiac disorders Supraventricular tachycardia	0.00% 0/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.49% 1/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Ear and labyrinth disorders Middle ear effusion	0.16% 1/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Ear and labyrinth disorders Otorrhoea	0.00% 0/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.49% 1/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Gastrointestinal disorders Oesophageal rupture	0.16% 1/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Infections and infestations Gastroenteritis rotavirus	0.48% 3/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Infections and infestations Gastroenteritis viral	0.00% 0/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.49% 1/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Infections and infestations Pharyngeal abscess	0.00% 0/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.49% 1/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Infections and infestations Viral tonsillitis	0.16% 1/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Infections and infestations Viral upper respiratory tract infection	0.16% 1/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Injury, poisoning and procedural complications Accidental exposure	0.16% 1/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Injury, poisoning and procedural complications Drug toxicity	0.16% 1/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Injury, poisoning and procedural complications Mouth injury	0.16% 1/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Infections and infestations Thermal burn	0.00% 0/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.49% 1/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.49% 1/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	0.00% 0/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.

Other adverse events

Measure	MenHibrix Group n=661 participants at risk Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB + Meningitec Group n=221 participants at risk Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.	ActHIB/PedvaxHIB Group n=221 participants at risk Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
General disorders Pain at the injection site	34.9% 217/622 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	29.7% 60/202 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	49.8% 100/201 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
General disorders Redness at the injection site	60.9% 379/622 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	50.5% 102/202 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	78.1% 157/201 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
General disorders Swelling at the injection site	36.2% 225/622 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	31.2% 63/202 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	61.2% 123/201 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
General disorders Drowsiness	31.5% 196/622 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	31.2% 63/202 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	35.3% 71/201 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
General disorders Fever	9.6% 60/622 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	6.9% 14/202 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	15.4% 31/201 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
General disorders Irritability	12.5% 78/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	17.0% 35/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	11.3% 23/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
General disorders Loss of appetite	36.0% 224/622 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	37.6% 76/202 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	30.8% 62/201 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Infections and infestations Upper respiratory tract infection	25.1% 157/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	19.4% 40/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	24.0% 49/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
General disorders Injection site bruising	6.6% 41/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	6.8% 14/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	8.3% 17/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Gastrointestinal disorders Teething	17.4% 109/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	19.9% 41/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	18.6% 38/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Gastrointestinal disorders Vomiting	7.7% 48/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	7.8% 16/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	7.8% 16/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Skin and subcutaneous tissue disorders Eczema	7.4% 49/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	7.2% 16/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	7.7% 17/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Skin and subcutaneous tissue disorders Rash	7.4% 49/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	9.0% 20/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	4.5% 10/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
General disorders Injection site nodule	6.7% 44/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	6.3% 14/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	4.5% 10/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
General disorders Pyrexia	5.6% 37/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	4.1% 9/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	8.1% 18/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Gastrointestinal disorders Diarrhea	6.1% 40/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	4.5% 10/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	3.6% 8/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	3.6% 24/661 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	1.8% 4/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	7.7% 17/221 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Gastrointestinal disorders Diarrhoea	8.8% 55/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	8.3% 17/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	7.8% 16/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Infections and infestations Otitis media	8.2% 51/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	6.8% 14/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	6.9% 14/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	7.0% 44/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	9.7% 20/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	8.3% 17/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.
Respiratory, thoracic and mediastinal disorders Cough	3.8% 24/625 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	4.4% 9/206 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.	6.4% 13/204 • Serious Adverse Events (SAEs): From Day 0 up to 18-21 months of age; Non-systematically assessed frequent AEs: Day 0-30 post-primary and post-fourth dose; Systematically assessed frequent AEs: Day 0-3 post-primary and post-fourth dose vaccination phase. SAEs and non-systematically assessed frequent AEs were assessed on the Primary \& Fourth dose Total Vaccinated Cohort, respectively. Systematically assessed frequent AEs were assessed on respectively subjects from the Primary and Fourth dose Total Vaccinated Cohort who returned their symptom sheet.

Additional Information

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GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

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

Restriction type: OTHER