A Study of the Immunogenicity, Tolerability, and Safety of a New Formulation of RotaTeq™ in Infants (V260-035 AM2)

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