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

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.

Time frame: 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.

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.

Time frame: 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.

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.

Time frame: 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 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.

Time frame: 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.

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.

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

Population: All Subjects as Treated with safety follow-up

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.

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

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

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.

Time frame: Up to 15 months

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.

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

Population: All Subjects as Treated with safety follow-up