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

Inclusion criteria

• Parent or legal guardian agrees to have infant participate by giving written informed consent

Exclusion criteria

• History of congenital abdominal disorders, prior rotavirus gastroenteritis, chronic diarrhea, failure to thrive, or abdominal surgery
• History of intussusception
• Known or suspected impairment of immunological function, including Severe

Combined Immunodeficiency (SCID)

• Prior administration of any rotavirus vaccine
• Clinical evidence of active gastrointestinal illness, with the exception of well-controlled gastroesophageal reflux disease (GERD)
• Receipt of 1) systemic corticosteroids (≥ 2mg/kg total daily dose of prednisone or equivalent) for 14 consecutive days or more since birth, or 2) systemic corticosteroids ≥ 2mg/kg/dose within 7 days prior to the administration of the first dose of study vaccine. Participant using non-systemic corticosteroids will be eligible for vaccination.
• Residing in a household with an immunocompromised person
• Prior receipt of a blood transfusion or blood products, including immunoglobulins
• Participation in another interventional study within 14 days prior to the first study vaccination or expected anytime during the study
• Receipt of investigational inactivated vaccines within 14 days or investigational live vaccines within 28 days prior to the first study vaccination or expected anytime during the study