P1096 (DAIDS ID 11796): Phase 1 Study to Determine the Safety, Infectivity, and Tolerability of 2 Doses of Live Attenuated Recombinant Cold-Passaged (cp) 45 Human Parainfluenza Type 3 Virus Vaccine, rHPIV3cp45, Lot PIV3#102A, Delivered as Nose Drops to HPIV3-Seronegative Infants and Children 6 to 36 Months of Age, at a 6 Month Interval

Study Status Study Restriction

Participants Off Study and Primary Analysis Completed

United States

What is P1096?

P1096 was a phase 1 randomized, double-blind, placebo-controlled, outpatient trial evaluating the safety, infectivity, tolerability, and immunogenicity of rHPIV3cp45, Lot PIV3#102A human parainfluenza virus type 3 (HPIV3) vaccine, delivered as nose drops. HPIV3-seronegative infants received 2 doses of vaccine or placebo, delivered approximately 6 months apart. This protocol was a companion protocol to CIR 255, a study being conducted by the Center for Immunization Research (Johns Hopkins, Baltimore) and the Laboratory of Infectious Diseases (NIAID, Bethesda). The primary objectives of the study were to determine the safety and immunogenicity of 2 doses of rHPIV3cp45, Lot PIV3#102A in 6 to 36-month-old HPIV3-seronegative infants.

Study documents:

Sites where the study was implemented:

CRS ID Site Name City Country

5083

Rush University Cook County Hospital Chicago NICHD CRS

Chicago

United States of America

Study contacts:

No records returned.

Study Co-Chair: Ruth Karron

CTS: Kathy George

 

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.