Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants (V260-014)(COMPLETED)

Safety and Immunogenicity of Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants

The study is being conducted to demonstrate that vaccine to prevent gastroenteritis due to rotavirus may be administered concomitantly with oral polio vaccine (OPV) without impairing the safety or immunogenicity of either vaccine.

Inclusion Criteria:

• Infants in good health

Exclusion Criteria:

• Previous administration of any oral poliovirus vaccine (OPV) and rotavirus vaccine
• Receipt of inactivated poliovirus vaccine (IPV) prior to the first dose of either study vaccine, or at any time during the course of the study
• Any condition resulting in depressed immunity
• Any allergy to any vaccine component as stated in the package circulars
• Allergies to polymyxin B, neomycin or any other antibiotics
• Receipt of intramuscular, oral, or intravenous corticosteroid treatment
• History of congenital abdominal disorders, intussusception, or abdominal surgery; clinical evidence of active gastrointestinal illness
• History of known prior rotavirus gastroenteritis, chronic diarrhea, or failure to thrive
• Prior receipt of a blood transfusion or blood products, including immunoglobulin
• Fever, with a rectal temperature of ≥38.1°C (≥ 100.5°F) at the time of immunization
• Infants residing in a household with an immunocompromised person