P1072 (DAIDS ID 10638): Safety and Immunogenicity of a Live, Attenuated, Rotavirus Vaccine (RotaTeqTM) in HIV-Infected and Uninfected Children Born to HIV-Infected Mothers
| Study Status | Study Restriction |
|---|---|
Participants Off Study and Primary Analysis Completed |
Non-US |
What is P1072?
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.
Study Documents:
Sites where the study is implemented:
| CRS ID | Site Name | City | Country |
|---|---|---|---|
Gaborone Prevention/Treatment Trials CRS |
Gaborone |
Botswana |
|
Molepolole Prevention/Treatment Trials CRS |
Molepolole |
Botswana |
|
Kilimanjaro Christian Medical CRS |
Moshi |
Tanzania |
|
George Clinic CRS |
Lusaka |
Zambia |
|
Harare Family Care CRS |
Harare |
Zimbabwe |
Study contacts:
Clinical Trials Specialist: Laura Phillips |