Immunogenicity and Safety of Concomitant Administration of RotaTeq™ (V260) and the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) in Healthy Japanese Infants (V260-060)

Post-marketing, Randomized, Open-label Study to Assess the Immunogenicity and Safety of Concomitant Administration of V260 and Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) in Japanese Healthy Infants

The study will evaluate the immunogenicity of the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) with concomitant administration of RotaTeq™ (V260) in healthy Japanese infants. The hypothesis to be tested is that the antibody response rates to DTP-IPV with concomitant administration of RotaTeq™ are non-inferior to those with staggered administration of RotaTeq™.

Inclusion Criteria:

• Japanese participant
• Age 6 weeks through <11 weeks (42 to 76 days from date of birth) at Visit 1

Exclusion Criteria:

• History of hypersensitivity and/or anaphylaxis to any of the product ingredients in V260 or DTP-IPV
• Gastrointestinal disorder, growth retardation, or failure to thrive
• History of intussusception
• Untreated congenital gastrointestinal disorder (such as Meckel diverticulum)
• Known or suspected impairment of immunological function, including severe immunodeficiency (SCID)
• Cardiovascular, renal, liver, or blood disease
• History of convulsion
• Undergoing immunosuppressive therapy or living with a close relative with congenital immune deficiency
• Prior vaccination with rotavirus vaccine and/or DTP-IPV vaccine
• Live vaccine received within 28 days or inactivated vaccine received within 7 days
• At high risk for tuberculosis exposure