Trial Outcomes & Findings for Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants (V260-024) (NCT NCT02062385)

NCT ID: NCT02062385

Last Updated: 2018-11-27

Results Overview

The number of participants with rotavirus gastroenteritis (RVGE) caused by naturally-occurring wild-type rotavirus (regardless of serotype or disease severity) was assessed. The case definition of RVGE included 1) 3 or more watery or looser-than-normal stools within a 24-hour period and/or forceful vomiting, and 2) naturally-occurring wild-type rotavirus must be detected in a stool specimen taken within 7 days after the onset of symptoms.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

4040 participants

Primary outcome timeframe

From 14 days after the third dose of V260 or placebo through the first rotavirus season (up to 15 months)

Results posted on

2018-11-27

Participant Flow

A total of 4173 participants were screened, 4040 were randomized, and 4037 received at least one dose of study vaccination.

Participant milestones

Participant milestones
Measure	V260 With Staggered EPI V260 administered as a 2 mL oral solution at age \~2, 3, and 4 months, and staggered China Expanded Program on Immunization (EPI) as follows: Oral poliovirus vaccine (OPV) administered as a 1 g oral solution at age \~2.5, 3.5, and 4.5 months, and diphtheria, tetanus, acellular pertussis vaccine (DTaP) administered as a 0.5 mL intramuscular injection at age \~3.5, 4.5, and 5.5 months.	Placebo With Staggered EPI Placebo administered as a 2 mL oral solution at age \~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age \~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3.5, 4.5, and 5.5 months.	V260 With Concomitant EPI V260 administered as a 2 mL oral solution at age \~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age \~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3, 4, and 5 months.	Placebo With Concomitant EPI Placebo administered as a 2 mL oral solution at age \~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age \~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3, 4, and 5 months.
Overall Study STARTED	1620	1620	400	400
Overall Study Received Vaccination 1	1618	1619	400	400
Overall Study Received Vaccination 2	1554	1566	392	393
Overall Study Received Vaccination 3	1543	1554	389	392
Overall Study COMPLETED	1542	1555	388	391
Overall Study NOT COMPLETED	78	65	12	9

Reasons for withdrawal

Reasons for withdrawal
Measure	V260 With Staggered EPI V260 administered as a 2 mL oral solution at age \~2, 3, and 4 months, and staggered China Expanded Program on Immunization (EPI) as follows: Oral poliovirus vaccine (OPV) administered as a 1 g oral solution at age \~2.5, 3.5, and 4.5 months, and diphtheria, tetanus, acellular pertussis vaccine (DTaP) administered as a 0.5 mL intramuscular injection at age \~3.5, 4.5, and 5.5 months.	Placebo With Staggered EPI Placebo administered as a 2 mL oral solution at age \~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age \~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3.5, 4.5, and 5.5 months.	V260 With Concomitant EPI V260 administered as a 2 mL oral solution at age \~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age \~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3, 4, and 5 months.	Placebo With Concomitant EPI Placebo administered as a 2 mL oral solution at age \~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age \~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3, 4, and 5 months.
Overall Study Adverse Event	19	13	1	0
Overall Study Protocol Violation	1	0	0	0
Overall Study Incomplete EPI by database lock	2	0	0	0
Overall Study Moved	10	11	1	0
Overall Study Withdrawn by parent/guardian	46	41	9	8
Overall Study Death	0	0	0	1
Overall Study Lost to Follow-up	0	0	1	0

Baseline Characteristics

Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants (V260-024)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	V260 With Staggered EPI n=1620 Participants V260 administered as a 2 mL oral solution at age \~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age \~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3.5, 4.5, and 5.5 months.	Placebo With Staggered EPI n=1620 Participants Placebo administered as a 2 mL oral solution at age \~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age \~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3.5, 4.5, and 5.5 months.	V260 With Concomitant EPI n=400 Participants V260 administered as a 2 mL oral solution at age \~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age \~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3, 4, and 5 months.	Placebo With Concomitant EPI n=400 Participants Placebo administered as a 2 mL oral solution at age \~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age \~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3, 4, and 5 months.	Total n=4040 Participants Total of all reporting groups
Age, Continuous	57.5 Days STANDARD_DEVIATION 10.0 • n=5 Participants	57.2 Days STANDARD_DEVIATION 9.7 • n=7 Participants	68.3 Days STANDARD_DEVIATION 5.7 • n=5 Participants	68.5 Days STANDARD_DEVIATION 5.7 • n=4 Participants	59.5 Days STANDARD_DEVIATION 10.2 • n=21 Participants
Sex: Female, Male Female	806 Participants n=5 Participants	775 Participants n=7 Participants	185 Participants n=5 Participants	183 Participants n=4 Participants	1949 Participants n=21 Participants
Sex: Female, Male Male	814 Participants n=5 Participants	845 Participants n=7 Participants	215 Participants n=5 Participants	217 Participants n=4 Participants	2091 Participants n=21 Participants

PRIMARY outcome

Timeframe: From 14 days after the third dose of V260 or placebo through the first rotavirus season (up to 15 months)

Population: Participants who were vaccinated in either the staggered EPI or concomitant EPI groups, were not protocol violators, and were classified as evaluable for RVGE according to the per-protocol case definition.

Outcome measures

Outcome measures
Measure	V260 With Staggered or Concomitant EPI n=1927 Participants V260 administered as a 2 mL oral solution at age \~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age \~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age \~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3, 4, and 5 months.	Placebo With Staggered or Concomitant EPI n=1937 Participants Placebo administered as a 2 mL oral solution at age \~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age \~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age \~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3, 4, and 5 months.
Number of Participants With Any Severity of Rotavirus Gastroenteritis	34 Participants	109 Participants

SECONDARY outcome

Timeframe: Up to 30 days after any dose of V260 or Placebo

Population: All Subjects as Treated with follow-up specific to the endpoint

Elevated temperature (temperature \>=37.5°C axillary or equivalent) was noted by the guardian and recorded on the Vaccination Report Card during Day 1 to Day 14 after each dose of vaccination. Elevated temperature reported by the guardian was also collected as an adverse event (pyrexia) during Day 15 to Day 30 after each dose of vaccination. The percentage of participants with axillary temperature \>=37.5 °C or an adverse event of pyrexia was assessed.

Outcome measures

Outcome measures
Measure	V260 With Staggered or Concomitant EPI n=2015 Participants V260 administered as a 2 mL oral solution at age \~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age \~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age \~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3, 4, and 5 months.	Placebo With Staggered or Concomitant EPI n=2019 Participants Placebo administered as a 2 mL oral solution at age \~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age \~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age \~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3, 4, and 5 months.
Percentage of Participants With Elevated Temperature	21.84 Percentage of participants	22.83 Percentage of participants

SECONDARY outcome

Timeframe: Up to 30 days after any dose of V260 or Placebo

Population: All Subjects as Treated with safety follow-up

Episodes of vomiting and diarrhea were noted by the guardian and recorded on the Vaccination Record Card during Day 1 to Day 14 after each dose of vaccination. Vomiting and diarrhea reported by the guardian were also collected as an adverse event during Day 15 to Day 30 after any dose of vaccination. The percentage of participants with an episode or an adverse event of vomiting or diarrhea was assessed.

Outcome measures

Outcome measures
Measure	V260 With Staggered or Concomitant EPI n=2015 Participants V260 administered as a 2 mL oral solution at age \~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age \~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age \~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3, 4, and 5 months.	Placebo With Staggered or Concomitant EPI n=2019 Participants Placebo administered as a 2 mL oral solution at age \~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age \~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age \~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3, 4, and 5 months.
Percentage of Participants With Vomiting or Diarrhea Vomiting	2.68 Percentage of participants	3.52 Percentage of participants
Percentage of Participants With Vomiting or Diarrhea Diarrhea	20.15 Percentage of participants	20.11 Percentage of participants

SECONDARY outcome

Timeframe: Up to 15 months

Population: All Subjects as Treated with safety follow-up

Episodes of intussusception were collected from the time of written consent until the end of study. The percentage of participants with an episode of intussusception was assessed.

Outcome measures

Outcome measures
Measure	V260 With Staggered or Concomitant EPI n=2015 Participants V260 administered as a 2 mL oral solution at age \~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age \~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age \~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3, 4, and 5 months.	Placebo With Staggered or Concomitant EPI n=2019 Participants Placebo administered as a 2 mL oral solution at age \~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age \~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age \~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3, 4, and 5 months.
Percentage of Participants With Intussusception	0.10 Percentage of participants	0.00 Percentage of participants

SECONDARY outcome

Timeframe: From 14 days after the third dose of V260 or placebo through the first rotavirus season (up to 15 months)

The number of participants with severe rotavirus gastroenteritis (RVGE) caused by naturally-occurring wild-type rotavirus (regardless of serotype or disease severity) was assessed. The case definition of RVGE included 1) 3 or more watery or looser-than-normal stools within a 24-hour period and/or forceful vomiting, and 2) naturally-occurring wild-type rotavirus must be detected in a stool specimen taken within 7 days after the onset of symptoms. Severe RVGE was defined as \>=11 on the Vesikari Scoring System, a composite of the seven parameters related to symptoms and treatment with an overall range from 0 to 20.

Outcome measures

Outcome measures
Measure	V260 With Staggered or Concomitant EPI n=1926 Participants V260 administered as a 2 mL oral solution at age \~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age \~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age \~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3, 4, and 5 months.	Placebo With Staggered or Concomitant EPI n=1937 Participants Placebo administered as a 2 mL oral solution at age \~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age \~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age \~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3, 4, and 5 months.
Number of Participants With Severe Rotavirus Gastroenteritis	11 Participants	52 Participants

SECONDARY outcome

Timeframe: Baseline and between 28 and 56 days after the third OPV vaccination

Population: Participants in the concomitant EPI groups who receive their scheduled doses of OPV without intervening disease specific to the antigen before the blood sample collection postdose 3, adhere to the guidelines for administration of vaccine, and have valid values available for analysis within specified day ranges.

The percentage of participants who achieved seroprotection against poliovirus Type 1, 2, or 3 was assessed. Seroprotection was defined as a neutralizing antibody titer \>=1:8. This outcome was evaluated only in participants receiving concomitant administration of V260 and OPV.

Outcome measures

Outcome measures
Measure	V260 With Staggered or Concomitant EPI n=187 Participants V260 administered as a 2 mL oral solution at age \~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age \~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age \~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3, 4, and 5 months.	Placebo With Staggered or Concomitant EPI n=192 Participants Placebo administered as a 2 mL oral solution at age \~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age \~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age \~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3, 4, and 5 months.
Percentage of Participants Who Achieved Seroprotection Against Poliovirus Type 1, 2, or 3 Poliovirus Type 1: Baseline, n=186, 190	44.09 Percentage of participants Interval 36.83 to 51.54	38.95 Percentage of participants Interval 31.97 to 46.27
Percentage of Participants Who Achieved Seroprotection Against Poliovirus Type 1, 2, or 3 Poliovirus Type 1: Post OPV #3, n=187, 192	98.93 Percentage of participants Interval 96.19 to 99.87	100.00 Percentage of participants Interval 98.1 to 100.0
Percentage of Participants Who Achieved Seroprotection Against Poliovirus Type 1, 2, or 3 Poliovirus Type 2: Baseline, n=186, 190	44.09 Percentage of participants Interval 36.83 to 51.54	41.58 Percentage of participants Interval 34.49 to 48.94
Percentage of Participants Who Achieved Seroprotection Against Poliovirus Type 1, 2, or 3 Poliovirus Type 2: Post OPV #3, n=187, 192	100.00 Percentage of participants Interval 98.05 to 100.0	100.00 Percentage of participants Interval 98.1 to 100.0
Percentage of Participants Who Achieved Seroprotection Against Poliovirus Type 1, 2, or 3 Poliovirus Type 3: Baseline, n=186, 190	25.27 Percentage of participants Interval 19.2 to 32.15	21.05 Percentage of participants Interval 15.49 to 27.54
Percentage of Participants Who Achieved Seroprotection Against Poliovirus Type 1, 2, or 3 Poliovirus Type 3: Post OPV #3, n=187, 192	98.93 Percentage of participants Interval 96.19 to 99.87	98.96 Percentage of participants Interval 96.29 to 99.87

SECONDARY outcome

Timeframe: Up to 30 days after any dose of V260 or Placebo

Population: All Subjects as Treated with safety follow-up

An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the sponsor's product, is also an adverse event.

Outcome measures

Outcome measures
Measure	V260 With Staggered or Concomitant EPI n=2015 Participants V260 administered as a 2 mL oral solution at age \~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age \~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age \~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3, 4, and 5 months.	Placebo With Staggered or Concomitant EPI n=2019 Participants Placebo administered as a 2 mL oral solution at age \~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age \~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age \~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3, 4, and 5 months.
Percentage of Participants With Any Adverse Event	53.5 Percentage of participants	53.3 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and between 28 and 51 days after the third DTaP vaccination

Population: Participants in the concomitant EPI groups who receive their scheduled doses of DTaP without intervening disease specific to the antigen before the blood sample collection postdose 3, adhere to the guidelines for administration of vaccine, and have valid values available for analysis within specified day ranges.

The percentage of participants seropositive to diphtheria, pertussis, or tetanus antigens was assessed. Seropositive was defined as the following: 1) anti-diphtheria antibody titers \>=0.1 International Units (IU)/mL, 2) anti-tetanus antibody titers \>=0.1 IU/mL, 3) antipertussis toxin antibody titers \>=20 Enzyme-linked Immunosorbent Assay (ELISA) Units (EU)/mL, 4) anti-pertussis filamentous hemagglutinin (FHA) antibody titers \>=20 EU/mL. This outcome was evaluated only in participants receiving concomitant administration of V260 and EPI.

Outcome measures

Outcome measures
Measure	V260 With Staggered or Concomitant EPI n=187 Participants V260 administered as a 2 mL oral solution at age \~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age \~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age \~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3, 4, and 5 months.	Placebo With Staggered or Concomitant EPI n=194 Participants Placebo administered as a 2 mL oral solution at age \~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age \~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age \~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3, 4, and 5 months.
Percentage of Participants Seropositive to Diphtheria, Pertussis, or Tetanus Antigens Diphtheria: Baseline, n=181, 186	3.31 Percentage of participants Interval 1.23 to 7.08	2.69 Percentage of participants Interval 0.88 to 6.16
Percentage of Participants Seropositive to Diphtheria, Pertussis, or Tetanus Antigens Diphtheria: Post DTaP #3, n=187, 194	99.47 Percentage of participants Interval 97.06 to 99.99	99.48 Percentage of participants Interval 97.16 to 99.99
Percentage of Participants Seropositive to Diphtheria, Pertussis, or Tetanus Antigens Pertussis FHA: Baseline, n=181, 186	0.00 Percentage of participants Interval 0.0 to 2.02	0.00 Percentage of participants Interval 0.0 to 1.96
Percentage of Participants Seropositive to Diphtheria, Pertussis, or Tetanus Antigens Pertussis FHA: Post DTaP #3, n=187, 194	44.92 Percentage of participants Interval 37.65 to 52.35	43.81 Percentage of participants Interval 36.72 to 51.1
Percentage of Participants Seropositive to Diphtheria, Pertussis, or Tetanus Antigens Pertussis Toxin: Baseline, n=181, 186	1.66 Percentage of participants Interval 0.34 to 4.77	1.08 Percentage of participants Interval 0.13 to 3.83
Percentage of Participants Seropositive to Diphtheria, Pertussis, or Tetanus Antigens Pertussis Toxin, Post DTaP #3, n=187, 194	95.19 Percentage of participants Interval 91.06 to 97.78	94.33 Percentage of participants Interval 90.08 to 97.14
Percentage of Participants Seropositive to Diphtheria, Pertussis, or Tetanus Antigens Tetanus: Baseline, n=181, 186	12.15 Percentage of participants Interval 7.78 to 17.82	12.37 Percentage of participants Interval 8.0 to 17.97
Percentage of Participants Seropositive to Diphtheria, Pertussis, or Tetanus Antigens Tetanus: Post DTaP #3, n=187, 194	100.00 Percentage of participants Interval 98.05 to 100.0	100.00 Percentage of participants Interval 98.12 to 100.0

Adverse Events

V260 With Staggered or Concomitant EPI

Serious events: 339 serious events

Other events: 938 other events

Deaths: 0 deaths

Placebo With Staggered or Concomitant EPI

Serious events: 338 serious events

Other events: 931 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	V260 With Staggered or Concomitant EPI n=2015 participants at risk V260 administered as a 2 mL oral solution at age \~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age \~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age \~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3, 4, and 5 months.	Placebo With Staggered or Concomitant EPI n=2019 participants at risk Placebo administered as a 2 mL oral solution at age \~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age \~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age \~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3, 4, and 5 months.
Gastrointestinal disorders Diarrhoea	20.1% 406/2015 • Number of events 487 • All Adverse Events: up to 30 days after any V260 or placebo vaccination; Serious Adverse Events: from the time of written consent until the end of the study (up to 15 months) The at-risk population was All Subjects as Treated	20.1% 406/2019 • Number of events 504 • All Adverse Events: up to 30 days after any V260 or placebo vaccination; Serious Adverse Events: from the time of written consent until the end of the study (up to 15 months) The at-risk population was All Subjects as Treated
General disorders Pyrexia	20.5% 414/2015 • Number of events 492 • All Adverse Events: up to 30 days after any V260 or placebo vaccination; Serious Adverse Events: from the time of written consent until the end of the study (up to 15 months) The at-risk population was All Subjects as Treated	20.8% 419/2019 • Number of events 481 • All Adverse Events: up to 30 days after any V260 or placebo vaccination; Serious Adverse Events: from the time of written consent until the end of the study (up to 15 months) The at-risk population was All Subjects as Treated
Infections and infestations Nasopharyngitis	11.3% 228/2015 • Number of events 248 • All Adverse Events: up to 30 days after any V260 or placebo vaccination; Serious Adverse Events: from the time of written consent until the end of the study (up to 15 months) The at-risk population was All Subjects as Treated	11.5% 233/2019 • Number of events 268 • All Adverse Events: up to 30 days after any V260 or placebo vaccination; Serious Adverse Events: from the time of written consent until the end of the study (up to 15 months) The at-risk population was All Subjects as Treated
Infections and infestations Upper respiratory tract infection	4.5% 91/2015 • Number of events 98 • All Adverse Events: up to 30 days after any V260 or placebo vaccination; Serious Adverse Events: from the time of written consent until the end of the study (up to 15 months) The at-risk population was All Subjects as Treated	5.1% 103/2019 • Number of events 114 • All Adverse Events: up to 30 days after any V260 or placebo vaccination; Serious Adverse Events: from the time of written consent until the end of the study (up to 15 months) The at-risk population was All Subjects as Treated
Respiratory, thoracic and mediastinal disorders Cough	5.7% 115/2015 • Number of events 133 • All Adverse Events: up to 30 days after any V260 or placebo vaccination; Serious Adverse Events: from the time of written consent until the end of the study (up to 15 months) The at-risk population was All Subjects as Treated	4.6% 92/2019 • Number of events 109 • All Adverse Events: up to 30 days after any V260 or placebo vaccination; Serious Adverse Events: from the time of written consent until the end of the study (up to 15 months) The at-risk population was All Subjects as Treated

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 must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
Publication restrictions are in place

Restriction type: OTHER