Trial Outcomes & Findings for Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4 and 12 Months (V419-007) (NCT NCT01341639)

Last Updated: 2019-04-30

Results Overview

Antibody titres in the PR5I group were measured by Radioimmunoassay (RIA) for Haemophilus influenzae type b (PRP), Micrometabolic inhibition test (MIT) for diphtheria \& poliovirus, and Enzyme-Linked Immunosorbent Assay (ELISA) for tetanus. Percentage of participants with an Ab titre ≥0.15 μg/mL for Haemophilus influenzae type b (Hib) (polyribosylribitol phosphate, PRP); ≥0.01 IU/mL; for diphtheria \& tetanus; ≥8 (1/dil) for inactivated poliovirus types 1, 2 \& 3 (IPV1, 2 \& 3) are reported. 95% confidence interval (CI) were calculated based on the exact binomial method by Clopper and Pearson. The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than the predetermined lower CI limits for PRP, diphtheria (80%), tetanus (90%), and IPV1, 2 \& 3 (90%).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1250 participants

Primary outcome timeframe

One month after post-dose 3 of PRI5 (5 months old)

Results posted on

2019-04-30

Participant Flow

Healthy infants 46 to 74 days old were enrolled in this study.

Participant milestones

Participant milestones
Measure	PR5I The PR5I group received V419, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by V419 and ProQuad™ at 12 months, and Prevenar 13™ and ProQuad™ at 13 months.	INFANRIX™ Hexa The INFANRIX™ hexa group received INFANRIX™ hexa, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by INFANRIX™ hexa and ProQuad™ at 12 months; and Prevenar 13™ and ProQuad™ at 13 months.
Infant Series STARTED	628	622
Infant Series Site 0048 Excluded	611	606
Infant Series Treated	610	605
Infant Series COMPLETED	599	590
Infant Series NOT COMPLETED	29	32
Interim Period STARTED	599	590
Interim Period COMPLETED	591	581
Interim Period NOT COMPLETED	8	9
Toddler Dose STARTED	590	582
Toddler Dose COMPLETED	539	548
Toddler Dose NOT COMPLETED	51	34
Post-Treatment STARTED	539	548
Post-Treatment COMPLETED	539	545
Post-Treatment NOT COMPLETED	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	PR5I The PR5I group received V419, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by V419 and ProQuad™ at 12 months, and Prevenar 13™ and ProQuad™ at 13 months.	INFANRIX™ Hexa The INFANRIX™ hexa group received INFANRIX™ hexa, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by INFANRIX™ hexa and ProQuad™ at 12 months; and Prevenar 13™ and ProQuad™ at 13 months.
Infant Series Protocol Violation	1	0
Infant Series Not Vaccinated	0	1
Infant Series Adverse Event	0	5
Infant Series Withdrawal by Subject	11	8
Infant Series Lost to Follow-up	0	2
Infant Series Site 0048 Participants	17	16
Interim Period Withdrawal by Subject	6	7
Interim Period Lost to Follow-up	2	0
Interim Period Physician Decision	0	1
Interim Period Protocol Violation	0	1
Post-Treatment Withdrawal by Subject	0	1
Post-Treatment Adverse Event	0	2

Baseline Characteristics

Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4 and 12 Months (V419-007)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PR5I n=611 Participants The PR5I group received V419, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by V419 and ProQuad™ at 12 months, and Prevenar 13™ and ProQuad™ at 13 months.	INFANRIX™ Hexa n=606 Participants The INFANRIX™ hexa group received INFANRIX™ hexa, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by INFANRIX™ hexa and ProQuad™ at 12 months; and Prevenar 13™ and ProQuad™ at 13 months.	Total n=1217 Participants Total of all reporting groups
Age, Continuous	61.4 Days STANDARD_DEVIATION 6.9 • n=5 Participants	61.5 Days STANDARD_DEVIATION 6.9 • n=7 Participants	61.5 Days STANDARD_DEVIATION 6.9 • n=5 Participants
Sex: Female, Male Female	291 Participants n=5 Participants	290 Participants n=7 Participants	581 Participants n=5 Participants
Sex: Female, Male Male	320 Participants n=5 Participants	316 Participants n=7 Participants	636 Participants n=5 Participants

PRIMARY outcome

Timeframe: One month after post-dose 3 of PRI5 (5 months old)

Population: All participants in the PR5I group who met inclusion criteria, were not protocol violators, received vaccinations within acceptable day ranges, and who had serology results within revised windows (RW) of Days 28 to 51 Post-Dose 3. Participants from site 0048 were excluded. Participants in the INFANRIX™ hexa group were not analyzed.

Outcome measures

Outcome measures
Measure	PR5I n=550 Participants The PR5I group received V419, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by V419 and ProQuad™ at 12 months, and Prevenar 13™ and ProQuad™ at 13 months.	INFANRIX™ Hexa The INFANRIX™ hexa group received INFANRIX™ hexa, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by INFANRIX™ hexa and ProQuad™ at 12 months; and Prevenar 13™ and ProQuad™ at 13 months.
Percentage of Participants Vaccinated With PR5I With Acceptable Antibody (Ab) Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months Anti-PRP ≥0.15 μg/mL	98.36 Percentage of participants Interval 96.92 to 99.25	—
Percentage of Participants Vaccinated With PR5I With Acceptable Antibody (Ab) Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months Anti-Diphtheria ≥0.01 IU/mL	99.82 Percentage of participants Interval 98.98 to 100.0	—
Percentage of Participants Vaccinated With PR5I With Acceptable Antibody (Ab) Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months Anti-Tetanus ≥0.01 IU/mL	100 Percentage of participants Interval 99.32 to 100.0	—
Percentage of Participants Vaccinated With PR5I With Acceptable Antibody (Ab) Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months Anti-IPV1 ≥8 (1/dil)	100 Percentage of participants Interval 99.33 to 100.0	—
Percentage of Participants Vaccinated With PR5I With Acceptable Antibody (Ab) Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months Anti-IPV2 ≥8 (1/dil)	99.82 Percentage of participants Interval 98.99 to 100.0	—
Percentage of Participants Vaccinated With PR5I With Acceptable Antibody (Ab) Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months Anti-IPV3 ≥8 (1/dil)	100 Percentage of participants Interval 99.33 to 100.0	—

PRIMARY outcome

Timeframe: One month after Toddler dose of PRI5 (13 months old)

Population: All participants in the PR5I group who met inclusion criteria, were not protocol violators, received vaccinations within acceptable day ranges, and who had serology results within RW of Days 28 to 51 Post-Toddler dose. Participants from site 0048 were excluded. Participants in the INFANRIX™ hexa group were not analyzed for this outcome measure.

Antibody titres in the PR5I group were measured by RIA for PRP, MIT for diphtheria \& poliovirus, enhanced Chemiluminescence assay (ECi)) for Hepatitis B surface antigen (HBsAg) and ELISA for tetanus, Pertussis toxoid (PT), Filamentous haemagglutinin (FHA), Fimbriae types 2 \& 3 (FIM) \& Pertactin (PRN). Percentage of participants with an Ab titre ≥1.0 μg/mL for Hib (PRP); ≥0.1 IU/mL; for diphtheria \& tetanus; ≥10 mIU/mL HBsAg; ≥8 (1/dil) for IPV1, 2 \& 3, and seroresponse to PT, FHA, FIM and PRN are reported. 95% confidence interval (CI) were calculated based on the exact binomial method by Clopper and Pearson. The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than the lower CI limits for PRP, PT, FHA, FIM, and PRN (75%); Diphtheria (80%); HBsAG, IPV 1, 2, 3 (90%).

Outcome measures

Outcome measures
Measure	PR5I n=551 Participants The PR5I group received V419, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by V419 and ProQuad™ at 12 months, and Prevenar 13™ and ProQuad™ at 13 months.	INFANRIX™ Hexa The INFANRIX™ hexa group received INFANRIX™ hexa, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by INFANRIX™ hexa and ProQuad™ at 12 months; and Prevenar 13™ and ProQuad™ at 13 months.
Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months Anti-PRP ≥1.0 μg/mL	94.99 Percentage of participants Interval 92.51 to 96.83	—
Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months Anti-HBsAg ≥10 mIU/mL	99.64 Percentage of participants Interval 98.7 to 99.96	—
Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months Anti-PT seroresponse	99.82 Percentage of participants Interval 98.98 to 100.0	—
Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months Anti-FHA seroresponse	97.23 Percentage of participants Interval 95.48 to 98.44	—
Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months Anti-FIM seroresponse	99.61 Percentage of participants Interval 98.59 to 99.95	—
Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months Anti-PRN seroresponse	98.9 Percentage of participants Interval 97.61 to 99.59	—
Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months Anti-Diphtheria ≥0.1 IU/mL	99.81 Percentage of participants Interval 98.96 to 100.0	—
Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months Anti-Tetanus ≥0.1 IU/mL	100 Percentage of participants Interval 99.3 to 100.0	—
Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months Anti-IPV1 ≥8 (1/dil)	99.81 Percentage of participants Interval 98.97 to 100.0	—
Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months Anti-IPV2 ≥8 (1/dil)	100 Percentage of participants Interval 99.32 to 100.0	—
Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months Anti-IPV3 ≥8 (1/dil)	100 Percentage of participants Interval 99.32 to 100.0	—

PRIMARY outcome

Timeframe: One month after post-dose 3 of PRI5 (5 months old)

Population: All participants who met inclusion criteria, were not protocol violators, received vaccinations within acceptable day ranges, and who had serology results within RW of Days 28 to 51 Post-Dose 3. Participants from site 0048 were excluded.

Antibody titres were measured by RIA for PRP, MIT for diphtheria \& poliovirus, and ELISA for tetanus. Percentage of participants with an Ab titre ≥0.15 μg/mL for Hib) (PRP); ≥0.01 IU/mL; for diphtheria \& tetanus; ≥8 (1/dil) for inactivated poliovirus types 1, 2 \& 3 (IPV1, 2 \& 3) are reported. The estimated response rates are based on the method by Miettinen and Nurminen stratified by country.

Outcome measures

Outcome measures
Measure	PR5I n=550 Participants The PR5I group received V419, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by V419 and ProQuad™ at 12 months, and Prevenar 13™ and ProQuad™ at 13 months.	INFANRIX™ Hexa n=530 Participants The INFANRIX™ hexa group received INFANRIX™ hexa, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by INFANRIX™ hexa and ProQuad™ at 12 months; and Prevenar 13™ and ProQuad™ at 13 months.
Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months Anti-PRP ≥0.15 μg/mL	98.36 Percentage of participants	86.99 Percentage of participants
Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months Anti-Diphtheria ≥0.01 IU/mL	99.81 Percentage of participants	99.81 Percentage of participants
Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months Anti-Tetanus ≥0.01 IU/mL	100 Percentage of participants	100 Percentage of participants
Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months Anti-IPV1 ≥8 (1/dil)	100 Percentage of participants	99.81 Percentage of participants
Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months Anti-IPV2 ≥8 (1/dil)	99.82 Percentage of participants	99.62 Percentage of participants
Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months Anti-IPV3 ≥8 (1/dil)	100 Percentage of participants	100 Percentage of participants

PRIMARY outcome

Timeframe: One month after Toddler dose of PRI5 (13 months old)

Antibody titres were measured by ECi for HBsAg and ELISA for PT, FHA, \& PRN. Percentage of participants with an Ab titre ≥10 mIU/mL HBsAg; ≥8 (1/dil) for IPV1, 2 \& 3, and seroresponse to PT, FHA, and PRN are reported. The estimated response rates are based on the method by Miettinen and Nurminen stratified by country.

Outcome measures

Outcome measures
Measure	PR5I n=551 Participants The PR5I group received V419, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by V419 and ProQuad™ at 12 months, and Prevenar 13™ and ProQuad™ at 13 months.	INFANRIX™ Hexa n=531 Participants The INFANRIX™ hexa group received INFANRIX™ hexa, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by INFANRIX™ hexa and ProQuad™ at 12 months; and Prevenar 13™ and ProQuad™ at 13 months.
Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response Rates to Hepatitis B and Seroresponse to Pertussis Antigens Pt, FHA and PRN One Month After the Toddler Dose at 13 Months Old Anti-HBsAg ≥10 mIU/mL	99.64 Percentage of participants	99.06 Percentage of participants
Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response Rates to Hepatitis B and Seroresponse to Pertussis Antigens Pt, FHA and PRN One Month After the Toddler Dose at 13 Months Old Anti-PT seroresponse	99.82 Percentage of participants	98.49 Percentage of participants
Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response Rates to Hepatitis B and Seroresponse to Pertussis Antigens Pt, FHA and PRN One Month After the Toddler Dose at 13 Months Old Anti-FHA seroresponse	97.22 Percentage of participants	99.81 Percentage of participants
Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response Rates to Hepatitis B and Seroresponse to Pertussis Antigens Pt, FHA and PRN One Month After the Toddler Dose at 13 Months Old Anti-PRN seroresponse	98.89 Percentage of participants	98.86 Percentage of participants

SECONDARY outcome

Timeframe: One month after Toddler dose of PRI5 (13 months old)

Population: All participants in the PR5I group who met inclusion criteria, were not protocol violators, received vaccinations within acceptable day ranges, and who had serology results within RW of Days 28 to 51 Post-Toddler dose. Participants from site 0048 were excluded. Participants in the INFANRIX™ hexa group were not analyzed for this outcome measure.

Ab titres were measured by ELISA, excepting the Ab to varicella which was determined by glycoprotein ELISA. Percentage of participants with an Ab titre ≥255 mIU/mL for measles, ≥10 Ab units/mL for mumps, ≥10 IU/mL for rubella, and ≥5 gpELISA units/mL for varicella are reported. 95% CI were calculated based on the exact binomial method by Clopper and Pearson. The immune response to ProQuad vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than the predetermined lower CI limits: 90% for measles, mumps \& rubella, and 76% for varicella.

Outcome measures

Outcome measures
Measure	PR5I n=467 Participants The PR5I group received V419, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by V419 and ProQuad™ at 12 months, and Prevenar 13™ and ProQuad™ at 13 months.	INFANRIX™ Hexa The INFANRIX™ hexa group received INFANRIX™ hexa, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by INFANRIX™ hexa and ProQuad™ at 12 months; and Prevenar 13™ and ProQuad™ at 13 months.
Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old Anti-Measles ≥255 mIU/mL	96.15 Percentage of participants Interval 93.98 to 97.7	—
Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old Anti-Mumps ≥10 Ab units/mL	94.86 Percentage of participants Interval 92.45 to 96.68	—
Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old Anti-Rubella ≥10 IU/mL	98.29 Percentage of participants Interval 96.65 to 99.26	—
Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old Anti-Varicella ≥5 gpELISA units/mL	97.64 Percentage of participants Interval 95.82 to 98.82	—

SECONDARY outcome

Timeframe: One month after Toddler dose of PRI5 (13 months old)

Outcome measures

Outcome measures
Measure	PR5I n=467 Participants The PR5I group received V419, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by V419 and ProQuad™ at 12 months, and Prevenar 13™ and ProQuad™ at 13 months.	INFANRIX™ Hexa n=474 Participants The INFANRIX™ hexa group received INFANRIX™ hexa, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by INFANRIX™ hexa and ProQuad™ at 12 months; and Prevenar 13™ and ProQuad™ at 13 months.
Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old Anti-Measles ≥255 mIU/mL	96.15 Percentage of participants	96.41 Percentage of participants
Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old Anti-Mumps ≥10 Ab units/mL	94.86 Percentage of participants	91.78 Percentage of participants
Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old Anti-Rubella ≥10 IU/mL	98.28 Percentage of participants	97.89 Percentage of participants
Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old Anti-Varicella ≥5 gpELISA units/mL	97.64 Percentage of participants	97.66 Percentage of participants

SECONDARY outcome

Timeframe: Day 1 to Day 15 after any vaccination

Population: All randomised participants who received at least 1 vaccination and who had safety follow-up. Participants from site 0048 were excluded.

Global safety was assessed by measuring injection-site and systemic AEs reported daily on the Vaccination Report Card (VRC) by the parent(s) or legal representative from Day 1 to Day 15 (D1-D15) after each hexavalent vaccination. Solicited injection-site and systemic AEs were reported daily from Day 1 to Day 5 (D1-D5) after each hexavalent vaccination. AEs at injection sites were always considered as vaccine-related (Injection-Site Reactions (ISRs)). The investigator assessed whether systemic AEs were related (V-related) or not to the vaccine. All AEs (related and unrelated) are reported.

Outcome measures

Outcome measures
Measure	PR5I n=610 Participants The PR5I group received V419, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by V419 and ProQuad™ at 12 months, and Prevenar 13™ and ProQuad™ at 13 months.	INFANRIX™ Hexa n=603 Participants The INFANRIX™ hexa group received INFANRIX™ hexa, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by INFANRIX™ hexa and ProQuad™ at 12 months; and Prevenar 13™ and ProQuad™ at 13 months.
Percentage of Participants With Injection-site and Systemic Adverse Events (AEs) From Day 1 to Day 15 After Any Vaccination At least 1 solicited ISR (D1-D5)	90.8 Percentage of participants	89.9 Percentage of participants
Percentage of Participants With Injection-site and Systemic Adverse Events (AEs) From Day 1 to Day 15 After Any Vaccination At least 1 systemic AE (D1-D15)	98.4 Percentage of participants	99.3 Percentage of participants
Percentage of Participants With Injection-site and Systemic Adverse Events (AEs) From Day 1 to Day 15 After Any Vaccination At least 1 V-related systemic AE (D1-D15)	95.6 Percentage of participants	96.5 Percentage of participants
Percentage of Participants With Injection-site and Systemic Adverse Events (AEs) From Day 1 to Day 15 After Any Vaccination At least 1 solicited systemic AE (D1-D5)	97 Percentage of participants	98.5 Percentage of participants
Percentage of Participants With Injection-site and Systemic Adverse Events (AEs) From Day 1 to Day 15 After Any Vaccination At least 1 V-related solicited systemic AE (D1-D5)	94.9 Percentage of participants	96.2 Percentage of participants
Percentage of Participants With Injection-site and Systemic Adverse Events (AEs) From Day 1 to Day 15 After Any Vaccination At least 1 ISR or systemic AE (D1-D15)	98.9 Percentage of participants	99.5 Percentage of participants
Percentage of Participants With Injection-site and Systemic Adverse Events (AEs) From Day 1 to Day 15 After Any Vaccination At least 1 ISR or V-related systemic AE (D1-D15)	98.5 Percentage of participants	98.8 Percentage of participants
Percentage of Participants With Injection-site and Systemic Adverse Events (AEs) From Day 1 to Day 15 After Any Vaccination At least 1 ISR (D1-D15)	92.1 Percentage of participants	91.0 Percentage of participants

SECONDARY outcome

Timeframe: Day 1 to Day 5 after any vaccination

Population: All randomised participants who received at least 1 vaccination and who had safety follow-up. Participants from site 0048 were excluded.

Solicited ISRs were defined as injection-site erythema, injection-site pain, and injection-site swelling occurring from Day 1 (D1) to Day 5 (D5) after vaccination. AEs at injection sites were always considered as vaccine-related (Injection-Site Reactions (ISRs)).

Outcome measures

Outcome measures
Measure	PR5I n=610 Participants The PR5I group received V419, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by V419 and ProQuad™ at 12 months, and Prevenar 13™ and ProQuad™ at 13 months.	INFANRIX™ Hexa n=603 Participants The INFANRIX™ hexa group received INFANRIX™ hexa, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by INFANRIX™ hexa and ProQuad™ at 12 months; and Prevenar 13™ and ProQuad™ at 13 months.
Percentage of Participants Reporting Solicited ISRs From Day 1 to Day 5 After Any Vaccination Injection-site erythema	69 Percentage of participants	64.2 Percentage of participants
Percentage of Participants Reporting Solicited ISRs From Day 1 to Day 5 After Any Vaccination Injection-site pain	73.6 Percentage of participants	71.8 Percentage of participants
Percentage of Participants Reporting Solicited ISRs From Day 1 to Day 5 After Any Vaccination Injection-site swelling	56.9 Percentage of participants	52.9 Percentage of participants

SECONDARY outcome

Timeframe: Day 1 to Day 15 after any vaccination

Population: All randomised participants who received at least 1 vaccination and who had safety follow-up. Participants from site 0048 were excluded.

Unsolicited ISRs with incidence ≥1% after any vaccination were reported daily on the VRC by the parent(s) or legal representative from (D1-D15). AEs at injection sites were always considered as vaccine-related ISRs

Outcome measures

Outcome measures
Measure	PR5I n=610 Participants The PR5I group received V419, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by V419 and ProQuad™ at 12 months, and Prevenar 13™ and ProQuad™ at 13 months.	INFANRIX™ Hexa n=603 Participants The INFANRIX™ hexa group received INFANRIX™ hexa, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by INFANRIX™ hexa and ProQuad™ at 12 months; and Prevenar 13™ and ProQuad™ at 13 months.
Percentage of Participants Reporting Unsolicited ISRs From Day 1 to Day 15 After Any Vaccination Injection-site bruising	2.8 Percentage of participants	2.7 Percentage of participants
Percentage of Participants Reporting Unsolicited ISRs From Day 1 to Day 15 After Any Vaccination Injection-site haematoma	1.5 Percentage of participants	0.8 Percentage of participants
Percentage of Participants Reporting Unsolicited ISRs From Day 1 to Day 15 After Any Vaccination Injection-site haemorrhage	1.3 Percentage of participants	2.0 Percentage of participants
Percentage of Participants Reporting Unsolicited ISRs From Day 1 to Day 15 After Any Vaccination Injection-site induration	14.6 Percentage of participants	18.2 Percentage of participants
Percentage of Participants Reporting Unsolicited ISRs From Day 1 to Day 15 After Any Vaccination Injection-site nodule	1.3 Percentage of participants	1.5 Percentage of participants
Percentage of Participants Reporting Unsolicited ISRs From Day 1 to Day 15 After Any Vaccination Injection-site warmth	3.0 Percentage of participants	1.8 Percentage of participants

SECONDARY outcome

Timeframe: Day 1 to Day 5 after any vaccination

Population: All randomised participants who received at least 1 vaccination and who had safety follow-up. Participants from site 0048 were excluded.

Solicited systemic AEs were defined as crying, decreased appetite, irritability, pyrexia (rectal temperature ≥38.0°C), somnolence, and vomiting occurring from D1 to D5 after vaccination. The investigator assessed whether these systemic AEs were related or not to the vaccines. All (related and unrelated) AEs are reported.

Outcome measures

Outcome measures
Measure	PR5I n=610 Participants The PR5I group received V419, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by V419 and ProQuad™ at 12 months, and Prevenar 13™ and ProQuad™ at 13 months.	INFANRIX™ Hexa n=603 Participants The INFANRIX™ hexa group received INFANRIX™ hexa, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by INFANRIX™ hexa and ProQuad™ at 12 months; and Prevenar 13™ and ProQuad™ at 13 months.
Percentage of Participants Reporting Solicited Systemic AE From Day 1 to Day 5 After Any Vaccination Crying	85.4 Percentage of participants	87.9 Percentage of participants
Percentage of Participants Reporting Solicited Systemic AE From Day 1 to Day 5 After Any Vaccination Decreased appetite	63.9 Percentage of participants	67.0 Percentage of participants
Percentage of Participants Reporting Solicited Systemic AE From Day 1 to Day 5 After Any Vaccination Irritability	87.9 Percentage of participants	85.7 Percentage of participants
Percentage of Participants Reporting Solicited Systemic AE From Day 1 to Day 5 After Any Vaccination Pyrexia	71.5 Percentage of participants	73.1 Percentage of participants
Percentage of Participants Reporting Solicited Systemic AE From Day 1 to Day 5 After Any Vaccination Somnolence	76.9 Percentage of participants	80.1 Percentage of participants
Percentage of Participants Reporting Solicited Systemic AE From Day 1 to Day 5 After Any Vaccination Vomiting	31.8 Percentage of participants	31.0 Percentage of participants

Adverse Events

PR5I

Serious events: 23 serious events

Other events: 603 other events

Deaths: 0 deaths

INFANRIX Hexa

Serious events: 22 serious events

Other events: 599 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The SPONSOR and SPONSOR representative must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR or SPONSOR representative as confidential must be deleted prior to submission.
Publication restrictions are in place

Restriction type: OTHER

Measure	PR5I n=610 participants at risk The PR5I group received V419, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by V419 and ProQuad™ at 12 months, and Prevenar 13™ and ProQuad™ at 13 months.	INFANRIX Hexa n=605 participants at risk The INFANRIX™ hexa group received INFANRIX™ hexa, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by INFANRIX™ hexa and ProQuad™ at 12 months; and Prevenar 13™ and ProQuad™ at 13 months.
Congenital, familial and genetic disorders Benign familial neonatal convulsions	0.00% 0/610 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	0.17% 1/605 • Number of events 1 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
Gastrointestinal disorders Inguinal hernia	0.16% 1/610 • Number of events 1 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	0.00% 0/605 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
Gastrointestinal disorders Oesophagitis	0.00% 0/610 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	0.17% 1/605 • Number of events 1 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
Gastrointestinal disorders Swollen tongue	0.00% 0/610 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	0.17% 1/605 • Number of events 1 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
General disorders Pyrexia	0.33% 2/610 • Number of events 2 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	0.33% 2/605 • Number of events 2 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
Infections and infestations Bronchiolitis	0.49% 3/610 • Number of events 3 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	0.33% 2/605 • Number of events 2 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
Infections and infestations Bronchitis	0.33% 2/610 • Number of events 2 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	0.17% 1/605 • Number of events 1 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
Infections and infestations Bronchitis viral	0.00% 0/610 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	0.17% 1/605 • Number of events 1 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
Infections and infestations Exanthema subitum	0.16% 1/610 • Number of events 1 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	0.00% 0/605 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
Infections and infestations Gastroenteritis	0.16% 1/610 • Number of events 1 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	0.00% 0/605 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
Infections and infestations Pneumococcal sepsis	0.00% 0/610 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	0.17% 1/605 • Number of events 1 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
Infections and infestations Pneumonia	0.16% 1/610 • Number of events 1 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	0.00% 0/605 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
Infections and infestations Pyelonephritis	0.33% 2/610 • Number of events 4 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	0.33% 2/605 • Number of events 2 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
Infections and infestations Pyelonephritis acute	0.16% 1/610 • Number of events 1 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	0.00% 0/605 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
Infections and infestations Respiratory syncytial virus bronchiolitis	0.49% 3/610 • Number of events 3 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	1.2% 7/605 • Number of events 7 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
Infections and infestations Respiratory tract infection	0.16% 1/610 • Number of events 1 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	0.00% 0/605 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
Infections and infestations Skin infection	0.00% 0/610 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	0.17% 1/605 • Number of events 1 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
Infections and infestations Urosepsis	0.16% 1/610 • Number of events 1 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	0.00% 0/605 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
Injury, poisoning and procedural complications Abdominal injury	0.00% 0/610 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	0.17% 1/605 • Number of events 1 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
Injury, poisoning and procedural complications Concussion	0.49% 3/610 • Number of events 3 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	0.17% 1/605 • Number of events 1 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
Injury, poisoning and procedural complications Skull fracture	0.16% 1/610 • Number of events 1 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	0.00% 0/605 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
Injury, poisoning and procedural complications Subdural haematoma	0.16% 1/610 • Number of events 1 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	0.00% 0/605 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/610 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	0.17% 1/605 • Number of events 1 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prolymphocytic leukaemia	0.16% 1/610 • Number of events 1 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	0.00% 0/605 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
Nervous system disorders Convulsion	0.16% 1/610 • Number of events 1 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	0.00% 0/605 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
Nervous system disorders Febrile convulsion	0.16% 1/610 • Number of events 1 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	0.00% 0/605 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
Respiratory, thoracic and mediastinal disorders Neuroendocrine cell hyperplasia of infancy	0.00% 0/610 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	0.17% 1/605 • Number of events 1 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.

Measure	PR5I n=610 participants at risk The PR5I group received V419, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by V419 and ProQuad™ at 12 months, and Prevenar 13™ and ProQuad™ at 13 months.	INFANRIX Hexa n=605 participants at risk The INFANRIX™ hexa group received INFANRIX™ hexa, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by INFANRIX™ hexa and ProQuad™ at 12 months; and Prevenar 13™ and ProQuad™ at 13 months.
Eye disorders Conjunctivitis	3.3% 20/610 • Number of events 23 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	5.3% 32/605 • Number of events 36 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
Gastrointestinal disorders Diarrhoea	16.1% 98/610 • Number of events 129 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	13.9% 84/605 • Number of events 113 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
Gastrointestinal disorders Flatulence	7.4% 45/610 • Number of events 55 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	6.4% 39/605 • Number of events 50 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
Gastrointestinal disorders Vomiting	33.6% 205/610 • Number of events 328 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	32.1% 194/605 • Number of events 333 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
General disorders Crying	85.7% 523/610 • Number of events 1543 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	87.8% 531/605 • Number of events 1482 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
General disorders Injection site erythema	75.2% 459/610 • Number of events 1745 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	71.1% 430/605 • Number of events 1517 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
General disorders Injection site induration	17.4% 106/610 • Number of events 245 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	21.0% 127/605 • Number of events 296 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
General disorders Injection site pain	76.9% 469/610 • Number of events 1710 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	75.4% 456/605 • Number of events 1637 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
General disorders Injection site swelling	63.0% 384/610 • Number of events 1214 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	57.4% 347/605 • Number of events 1101 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
General disorders Irritability	88.0% 537/610 • Number of events 1639 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	85.6% 518/605 • Number of events 1570 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
General disorders Pyrexia	77.2% 471/610 • Number of events 1072 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	78.0% 472/605 • Number of events 1065 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
Infections and infestations Nasopharyngitis	3.9% 24/610 • Number of events 29 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	5.8% 35/605 • Number of events 41 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
Infections and infestations Otitis media	5.2% 32/610 • Number of events 33 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	4.3% 26/605 • Number of events 30 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
Infections and infestations Rhinitis	13.4% 82/610 • Number of events 102 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	14.2% 86/605 • Number of events 101 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
Infections and infestations Upper respiratory tract infection	11.3% 69/610 • Number of events 82 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	12.6% 76/605 • Number of events 83 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
Metabolism and nutrition disorders Decreased appetite	65.7% 401/610 • Number of events 752 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	67.4% 408/605 • Number of events 718 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
Nervous system disorders Somnolence	77.0% 470/610 • Number of events 1082 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	80.2% 485/605 • Number of events 1058 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
Respiratory, thoracic and mediastinal disorders Cough	5.7% 35/610 • Number of events 39 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	6.3% 38/605 • Number of events 44 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.
Skin and subcutaneous tissue disorders Rash	5.7% 35/610 • Number of events 42 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.	4.5% 27/605 • Number of events 32 • 2 months after Toddler Dose (up to approximately age 14 months) All Treated Participants. Participants from site 0048 were excluded.