Trial Outcomes & Findings for A Study of the Immunogenicity, Tolerability, and Safety of a New Formulation of RotaTeq™ in Infants (V260-035) (NCT NCT01600092)

NCT ID: NCT01600092

Last Updated: 2018-11-14

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1020 participants
• Primary outcome timeframe: 42 days after vaccination 3 (up to 185 days)
• Results posted on: 2018-11-14

Participant Flow

A total of 1039 participants were screened

Participant milestones

Measure	RotaTeq™ Experimental Formulation Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).	RotaTeq™ Existing Formulation Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
Overall Study STARTED	513	507
Overall Study Received at Least 1 Vaccination	510	504
Overall Study Received All 3 Vaccinations	500	494
Overall Study COMPLETED	495	491
Overall Study NOT COMPLETED	18	16

Reasons for withdrawal

Measure	RotaTeq™ Experimental Formulation Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).	RotaTeq™ Existing Formulation Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
Overall Study Adverse Event	2	0
Overall Study Lost to Follow-up	4	6
Overall Study Withdrawal by parent/guardian	8	6
Overall Study Physician Decision	1	1
Overall Study Randomized but not vaccinated	3	3

Baseline Characteristics

A Study of the Immunogenicity, Tolerability, and Safety of a New Formulation of RotaTeq™ in Infants (V260-035)

Baseline characteristics by cohort

Measure	RotaTeq™ Experimental Formulation n=513 Participants Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).	RotaTeq™ Existing Formulation n=507 Participants Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).	Total n=1020 Participants Total of all reporting groups
Age, Continuous	8.4 Weeks STANDARD_DEVIATION 1.4 • n=5 Participants	8.3 Weeks STANDARD_DEVIATION 1.4 • n=7 Participants	8.3 Weeks STANDARD_DEVIATION 1.4 • n=5 Participants
Sex: Female, Male Female	232 Participants n=5 Participants	240 Participants n=7 Participants	472 Participants n=5 Participants
Sex: Female, Male Male	281 Participants n=5 Participants	267 Participants n=7 Participants	548 Participants n=5 Participants

PRIMARY outcome

Timeframe: 42 days after vaccination 3 (up to 185 days)

Population: Participants who received the 3 scheduled doses of study vaccine, did not have important protocol deviations, and had follow-up results for the endpoint

Outcome measures

Measure	RotaTeq™ Experimental Formulation n=480 Participants Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).	RotaTeq™ Existing Formulation n=482 Participants Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] Serotype G1	99.8 Titer Interval 89.7 to 111.1	106.1 Titer Interval 94.6 to 119.0
Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] Serotype G2	30.0 Titer Interval 27.0 to 33.3	26.3 Titer Interval 23.7 to 29.1
Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] Serotype G3	82.8 Titer Interval 74.2 to 92.5	25.2 Titer Interval 22.6 to 28.1
Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] Serotype G4	78.9 Titer Interval 72.3 to 86.1	71.5 Titer Interval 65.4 to 78.1
Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] Serotype P1A[8]	106.9 Titer Interval 96.5 to 118.4	90.1 Titer Interval 80.2 to 101.2

SECONDARY outcome

Timeframe: Up to 7 days after any vaccination (up to 147 days)

Population: Participants who received at least one dose of study vaccine. Participants were assigned to treatment groups based on the vaccine received as the first dose.

An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. Protocol-defined Tier-1 adverse events to be collected up to 7 days after any vaccination were diarrhea, vomiting, elevated temperature (rectal >=38.1° C, >=100.5° F), and irritability.

Outcome measures

Measure	RotaTeq™ Experimental Formulation n=509 Participants Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).	RotaTeq™ Existing Formulation n=505 Participants Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
Number of Participants With Tier-1 Adverse Events: Diarrhea, Vomiting, Elevated Temperature, and Irritability Diarrhea	144 Participants	128 Participants
Number of Participants With Tier-1 Adverse Events: Diarrhea, Vomiting, Elevated Temperature, and Irritability Vomiting	84 Participants	92 Participants
Number of Participants With Tier-1 Adverse Events: Diarrhea, Vomiting, Elevated Temperature, and Irritability Elevated temperature	217 Participants	223 Participants
Number of Participants With Tier-1 Adverse Events: Diarrhea, Vomiting, Elevated Temperature, and Irritability Irritability	58 Participants	64 Participants

SECONDARY outcome

Timeframe: Up to Day 185

Population: Participants who received at least one dose of study vaccine. Participants were assigned to treatment groups based on the vaccine received as the first dose.

The protocol-defined Tier-1 adverse event to be collected for the duration of the study (up to Day 185) was intussusception

Outcome measures

Measure	RotaTeq™ Experimental Formulation n=509 Participants Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).	RotaTeq™ Existing Formulation n=505 Participants Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
Number of Participants With Tier-1 Adverse Events: Intussusception	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 42 days after vaccination 3 (up to 185 days)

Population: Participants who received the 3 scheduled doses of study vaccine, did not have important protocol deviations, and had follow-up results for the endpoint

Outcome measures

Measure	RotaTeq™ Experimental Formulation n=474 Participants Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).	RotaTeq™ Existing Formulation n=474 Participants Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
Geometric Mean Titer of Serum Anti-Rotavirus Immunoglobulin A	240.5 Titer Interval 210.4 to 274.8	235.5 Titer Interval 204.1 to 271.8

SECONDARY outcome

Timeframe: Baseline and 42 days after vaccination 3 (up to 185 days)

Population: Participants who received the 3 scheduled doses of study vaccine, did not have important protocol deviations, and had baseline and follow-up results for the endpoint

Outcome measures

Measure	RotaTeq™ Experimental Formulation n=480 Participants Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).	RotaTeq™ Existing Formulation n=481 Participants Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
Percentage of Participants With >=3-fold Rise From Baseline in GMT of Serum Neutralizing Antibody to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] Serotype G1	56.0 Percentage of participants Interval 51.5 to 60.5	53.8 Percentage of participants Interval 49.3 to 58.4
Percentage of Participants With >=3-fold Rise From Baseline in GMT of Serum Neutralizing Antibody to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] Serotype G2	30.4 Percentage of participants Interval 26.3 to 34.7	26.8 Percentage of participants Interval 22.9 to 31.0
Percentage of Participants With >=3-fold Rise From Baseline in GMT of Serum Neutralizing Antibody to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] Serotype G3	65.8 Percentage of participants Interval 61.4 to 70.1	33.3 Percentage of participants Interval 29.1 to 37.7
Percentage of Participants With >=3-fold Rise From Baseline in GMT of Serum Neutralizing Antibody to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] Serotype G4	58.3 Percentage of participants Interval 53.8 to 62.8	49.7 Percentage of participants Interval 45.1 to 54.3
Percentage of Participants With >=3-fold Rise From Baseline in GMT of Serum Neutralizing Antibody to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] Serotype P1A[8]	49.6 Percentage of participants Interval 45.0 to 54.2	42.6 Percentage of participants Interval 38.2 to 47.2

Adverse Events

RotaTeq™ Experimental Formulation

Serious events: 20 serious events

Other events: 398 other events

Deaths: 0 deaths

RotaTeq™ Existing Formulation

Serious events: 12 serious events

Other events: 385 other events

Deaths: 0 deaths

Serious adverse events

Measure	RotaTeq™ Experimental Formulation n=508 participants at risk Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).	RotaTeq™ Existing Formulation n=499 participants at risk Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
Gastrointestinal disorders Intussusception	0.39% 2/508 • Number of events 2 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up	0.00% 0/499 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up
Gastrointestinal disorders Umbilical hernia	0.00% 0/508 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up	0.20% 1/499 • Number of events 1 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up
General disorders Pyrexia	0.20% 1/508 • Number of events 1 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up	0.00% 0/499 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up
Infections and infestations Anal abscess	0.20% 1/508 • Number of events 1 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up	0.20% 1/499 • Number of events 1 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up
Infections and infestations Bronchiolitis	0.59% 3/508 • Number of events 3 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up	0.20% 1/499 • Number of events 1 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up
Infections and infestations Bronchitis	0.00% 0/508 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up	0.20% 1/499 • Number of events 1 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up
Infections and infestations Cellulitis	0.20% 1/508 • Number of events 1 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up	0.00% 0/499 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up
Infections and infestations Gastroenteritis viral	0.00% 0/508 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up	0.20% 1/499 • Number of events 1 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up
Infections and infestations Laryngitis	0.20% 1/508 • Number of events 1 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up	0.00% 0/499 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up
Infections and infestations Parainfluenzae virus infection	0.20% 1/508 • Number of events 1 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up	0.00% 0/499 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up
Infections and infestations Pneumonia	0.39% 2/508 • Number of events 2 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up	0.00% 0/499 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up
Infections and infestations Pyelonephritis	0.20% 1/508 • Number of events 1 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up	0.20% 1/499 • Number of events 1 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up
Infections and infestations Pyelonephritis acute	0.00% 0/508 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up	0.20% 1/499 • Number of events 1 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up
Infections and infestations Respiratory syncytial virus bronchiolitis	0.20% 1/508 • Number of events 1 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up	0.00% 0/499 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up
Infections and infestations Respiratory tract infection viral	0.00% 0/508 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up	0.20% 1/499 • Number of events 1 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up
Infections and infestations Septic shock	0.20% 1/508 • Number of events 1 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up	0.00% 0/499 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up
Infections and infestations Upper respiratory tract infection	0.20% 1/508 • Number of events 1 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up	0.00% 0/499 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up
Infections and infestations Urinary tract infection	0.20% 1/508 • Number of events 1 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up	0.20% 1/499 • Number of events 1 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up
Infections and infestations Viral infection	0.20% 1/508 • Number of events 1 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up	0.20% 1/499 • Number of events 1 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up
Injury, poisoning and procedural complications Head injury	0.00% 0/508 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up	0.20% 1/499 • Number of events 1 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up
Injury, poisoning and procedural complications Subcutaneous haematoma	0.00% 0/508 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up	0.20% 1/499 • Number of events 1 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up
Nervous system disorders Hypersomnia	0.20% 1/508 • Number of events 1 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up	0.00% 0/499 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up
Nervous system disorders Loss of consciousness	0.20% 1/508 • Number of events 1 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up	0.00% 0/499 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up
Psychiatric disorders Restlessness	0.00% 0/508 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up	0.20% 1/499 • Number of events 1 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up

Other adverse events

Measure	RotaTeq™ Experimental Formulation n=508 participants at risk Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).	RotaTeq™ Existing Formulation n=499 participants at risk Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
Gastrointestinal disorders Constipation	5.9% 30/508 • Number of events 33 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up	4.4% 22/499 • Number of events 29 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up
Gastrointestinal disorders Diarrhoea	34.1% 173/508 • Number of events 307 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up	31.3% 156/499 • Number of events 276 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up
Gastrointestinal disorders Vomiting	20.1% 102/508 • Number of events 175 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up	21.4% 107/499 • Number of events 180 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up
General disorders Pyrexia	29.7% 151/508 • Number of events 211 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up	30.5% 152/499 • Number of events 231 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up
Infections and infestations Conjunctivitis	5.3% 27/508 • Number of events 35 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up	5.0% 25/499 • Number of events 25 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up
Infections and infestations Nasopharyngitis	15.6% 79/508 • Number of events 106 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up	16.6% 83/499 • Number of events 113 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up
Infections and infestations Otitis media	3.9% 20/508 • Number of events 26 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up	5.8% 29/499 • Number of events 33 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up
Infections and infestations Rhinitis	8.3% 42/508 • Number of events 53 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up	8.0% 40/499 • Number of events 56 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up
Infections and infestations Upper respiratory tract infection	15.4% 78/508 • Number of events 97 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up	13.4% 67/499 • Number of events 87 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up
Psychiatric disorders Irritability	12.8% 65/508 • Number of events 98 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up	15.4% 77/499 • Number of events 113 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up
Respiratory, thoracic and mediastinal disorders Cough	7.1% 36/508 • Number of events 39 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up	8.8% 44/499 • Number of events 50 • All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185 The participants at risk includes participants who received at least one dose of study vaccine and had follow-up

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme, Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.
• Publication restrictions are in place

Restriction type: OTHER