Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants (V260-024)
Condition: Rotavirus Gastroenteritis
MeSH terms: Gastroenteritis
Intervention: V260; Placebo to V260; OPV; DTaP
Intervention description: V260 (RotaTeq™; live, oral, pentavalent rotavirus vaccine); Placebo control; Oral poliovirus vaccine administered according to the standard of care; Diphtheria, Tetanus, Acellular Pertussis vaccine administered according to the standard of care
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 4040.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      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.
    

Eligibility criteria:

        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