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Safety and Immunogenicity of a Live, Attenuated, Rotavirus Vaccine (RotaTeq™) in HIV-1 Infected and Uninfected Children Born to HIV-1 Infected Mothers

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P1072 is a phase II, randomized, double-blind, placebo controlled study of the safety and immunogenicity of a live, attenuated rotavirus vaccine (RotaTeq™) in HIV-1 infected and uninfected children  ≥2 weeks to <15 weeks of age born to HIV-1 infected mothers.  This study will enroll 320 children (160 HIV-1 infected and 160 HIV-uninfected).  Participants will receive three doses (2.0 mL each) of either a live attenuated rotavirus vaccine (RotaTeq™) or placebo.  The primary objectives of this study are to evaluate the safety of any dose of RotaTeq™ and to evaluate the immunogenicity of a 3-dose regimen of RotaTeq™ in HIV-1 infected and uninfected children born to HIV-1 infected mothers.

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