P1057 (10270): A Phase I/II Randomized Trial of the Safety and Immunogenicity of Cold-Adapted Influenza Vaccine (FluMist) in HIV-Infected Children

Study Status Study Restriction

Participants Off Study and Primary Analysis Completed

Not Applicable

What is P1057?

P1057 was a Phase I/II, open label study of cold-adapted live attenuated influenza vaccine (FluMistā„¢) compared to inactivated influenza vaccine (IAIV, FluzoneĀ®).  The study was designed to compare the safety and immunogenicity of FluMistTM with IAIV among HIV-infected children and adolescents as well as determine the prevalence and duration of viral shedding of FluMistTM in HIV-infected vaccinees.

Study Documents:

Sites where the study was implemented:

CRS ID Site Name City Country


Boston Medical Center Pediatric HIV Program


United States of America

Study contacts:

No records returned.

CTS: IMPAACT Operations Center


Funded by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health of the US National Institutes of Health, US Department of Health and Human Services.