Safety,Tolerability and Immunogenicity of Vaccination With Rotateq in Healthy Infants in India (V260-021)

Evaluation of Safety,Tolerability and Immunogenicity of Vaccination With Rotateq (V260) in Healthy Infants in India

To observe the safety, tolerability and immunogenicity of the administration of 3 doses of rotateq in healthy Indian infants between 6 weeks through exactly 12 weeks of age at entry.

Inclusion Criteria:

• Age 6 weeks through exactly 12 weeks
• Healthy infants

Exclusion Criteria:

• Clinical evidence of active gastrointestinal illness
• Fever, with a rectal temperature of greater than and equal to thirty eight degree celsius at the time of immunization
• History of congenital abdominal disorders, intussusception, or abdominal surgery
• History of known prior rotavirus disease
• Known or suspected impairment of immunological function
• Prior administration of any rotavirus vaccine
• Known hypersensitivity to any component of the rotavirus vaccine, e.g. trypsin