V260 Study: Concomitant Use of V260 and INFANRIX™ Hexa in Healthy Infants (V260-010)

Inclusion Criteria

• Healthy infant per investigator, 6 through 12 weeks of age

Exclusion Criteria

• History of congenital abdominal disorders, intussusception, or abdominal surgery
• Known or suspected impairment of immunological function
• Known hypersensitivity to any component of the rotavirus vaccine
• Prior administration of any rotavirus vaccine
• Known hypersensitivity or contraindication to any component of INFANRIX(tm) hexa
• Any infant born from a known HBsAg-positive mother
• Prior administration of any oral polio vaccine
• Receipt of one or more doses of inactivated poliovirus vaccine, diptheria, tetanus and acellular pertussis vaccine, diptheria, tetanus and pertussis vaccine, Haemophilus influenzae type b vaccine, or any hepatitis B vaccine prior to the first vaccination, or receipt of any vaccines with these antigens at any time during the course of the study
• Fever, with a rectal temperature greater than or equal to 38.1 degree C (greater than or equal to 100.5 degree F) at the time of immunization
• History of known prior rotavirus gastroenteritis, chronic diarrhea, or failure to thrive
• Clinical evidence of active gastrointestinal illness
• Receipt of intramuscular, oral, or intravenous corticosteroid treatment within the 2 weeks prior to vaccination
• Infants residing in a household with an immunocompromised person
• Prior receipt of a blood transfusion or blood products
• Participation in another clinical study within 42 days before the beginning or anytime during the duration of the current clinical study
• Any infant who cannot be adequately followed for safety by a contact visit
• History of seizure disorders or prior history followed for safety by a contact visit
• Any condition that, in the opinion of the investigator, may interfere with the evaluation of the study objectives