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

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants

This study will assess the efficacy, safety, and immunogenicity of a 3-dose regimen of RotaTeq™ (V260) in healthy Chinese infants. Approximately 4040 participants at least 6 weeks and up to 12 weeks of age at the time of the first vaccination with V260 or placebo will be enrolled and randomized (1:1) to receive either V260 or placebo. Participants will also receive the routine China Expanded Program on Immunization (EPI) vaccines (oral poliovirus vaccine [OPV] and diphtheria, tetanus, and acellular pertussis vaccine [DTaP]) either staggered or concomitantly with V260 or placebo. All participants will be followed for efficacy and safety. Immune responses to OPV and DTaP will be evaluated in a subset of participants. The primary hypothesis of the study states that V260 will be efficacious in preventing any severity of rotavirus gastroenteritis as compared with placebo.

Inclusion Criteria:

• Healthy infants at least 6 weeks (42 days) and up to 12 weeks (84 days) of age at the time of the first study vaccination
• Parent/legal guardian agrees to participate by giving written informed consent and is willing and able to comply with study requirements

Exclusion Criteria:

• History of congenital abdominal disorders, prior rotavirus gastroenteritis, chronic diarrhea, failure to thrive, or abdominal surgery
• History of intussusception
• Impairment of immunological function, including Severe Combined Immunodeficiency (SCID)
• Acute disease, severe chronic disease, or chronic disease during the acute period
• Uncontrolled epilepsy, encephalopathy, seizure, or other progressive neurological disease
• Hypersensitivity to any component of the rotavirus vaccine, OPV, or DTaP
• Prior receipt of any rotavirus vaccine
• Fever, with an axillary temperature >=37.5 °C (or equivalent) within 24 hours before study vaccination (study vaccination can be deferred until complete resolution of febrile illness)
• Clinical evidence of active gastrointestinal illness
• Received intramuscular, oral, or intravenous corticosteroid treatment since birth (topical, ophthalmic, and inhaled steroids are permitted)
• Resides in a household with an immunocompromised person
• Receipt of a blood transfusion or blood products, including immunoglobulins
• Participation in another interventional study within 14 days before the first study vaccination or during the study
• Receipt of an investigational or non-registered product other than the study vaccine within 30 days before the first study vaccination or during the study
• For participants in immunogenicity arms: inability to obtain a blood specimen at randomization visit (note: the visit may be rescheduled so that a baseline specimen may be obtained); history of polio, diphtheria, tetanus, or pertussis disease; previous vaccination against diphtheria, tetanus, pertussis, or poliomyelitis
• Any condition which, in the opinion of the investigator, may interfere with the evaluation of the study objectives