Clinical Trials Link
Primary Protocol Team Members
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.