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IMPAACT 2038

Phase I Study of the Infectivity, Safety, and Immunogenicity of a Single Dose of Recombinant, Live-Attenuated, Bovine/Human, Parainfluenza Virus Type 3 (B/HPIV3) Vector Vaccines B/HPIV3/RSV/PreF, B/HPIV3/RSV/PreF/TM, or Placebo, Delivered via Nasal Sprayer to HPIV3-Seronegative Children 6 to 24 Months of Age

Study Status

In Development

DAIDS Number

39100

Summary

IMPAACT 2038 is a Phase I, double-blinded, placebo-controlled, randomized study that will evaluate the infectivity, safety, and immunogenicity of recombinant, live-attenuated bovine/human, parainfluenza virus type 3 (B/HPIV3) vector vaccines B/HPIV3/RSV/PreF, B/HPIV3/RSV/PreF/TM, or placebo in HPIV3-seronegative children. Approximately 70 healthy HPIV3-seronegative children ‚Č•6 months (180 days) to <25 months (750 days) of age will be enrolled. Eligible children will receive a single intranasal dose of B/HPIV3/RSV/PreF vaccine, B/HPIV3/RSV/PreF/TM vaccine, or placebo at entry.¬†Participants will be enrolled in the study outside the time during which wild-type RSV circulates in the community at each study site and will remain on study with follow-up visits through Day 28 after receipt of study product and non-visit contacts thereafter to monitor for adverse events.

Study Vice-Chair

NICHD Medical Officer

Clinical Research Manager

Community Program Manager

Laboratory Data Manager (LDM)

Laboratory Specialist

Laboratory Technologist

Protocol Pharmacist

Westat Representative