P1096 / Phase 1 Study of Live Attenuated Recombinant (cp) 45 Human Parainfluenza Type 3 Vaccine

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.