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Study of the Infectivity, Safety and Immunogenicity of Two Recombinant, Live-Attenuated, B/HPIV3 Vectored Vaccines Expressing the Fusion Glycoprotein of HMPV Delivered by Nasal Spray to HPIV3-Seropositive Children 24 to <60 Months of Age

StatusCompleted
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Results posted: Sep 18, 2026 Primary endpoints: 5 to 6 · Interventions: B/HPIV3/HMPV-F-B365 vaccine (Biological), B/HPIV3/HMPV-PreF-A vaccine (Biological), Placebo (Drug) to B/HPIV3/HMPV-F-B365 vaccine (Biological), B/HPIV3/HMPV-PreF-A vaccine (Biological), Placebo (Drug) · Eligibility criteria expanded, about 52 words · 2 more Show 5 more changesShow less
    • Primary endpoints: 5 to 6
    • Interventions: B/HPIV3/HMPV-F-B365 vaccine (Biological), B/HPIV3/HMPV-PreF-A vaccine (Biological), Placebo (Drug) to B/HPIV3/HMPV-F-B365 vaccine (Biological), B/HPIV3/HMPV-PreF-A vaccine (Biological), Placebo (Drug)
    • Eligibility criteria expanded, about 52 words
    • Secondary endpoints: 1 to 2
    • Study description revised
  2. Trial status: Recruiting to Completed Enrollment target: estimated 25 to confirmed 24 · Primary and study completion dates changed from estimate of Jun 2025 to Jun 4, 2025 · Site details revised at 4 of 4 sitesv3 Show 3 more changesShow less
    • Enrollment target: estimated 25 to confirmed 24
    • Primary and study completion dates changed from estimate of Jun 2025 to Jun 4, 2025
    • Site details revised at 4 of 4 sites
  3. Re-verified, no change to tracked fieldsv2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
HPIV3 and HMPV are viruses that can cause breathing problems in children. The goal of this clinical trial is to look at the safety of 2 experimental HPIV3/HMPV vaccines in HPIV3-seropositive children ≥ 24 months to \< 60 months of age. Children will receive B/HPIV3/HMPV-PreF-A vaccine, B/HPIV3/HMPV-F-B365 vaccine, or placebo, and participants will not know which study product they have received. The main goals of the study are to find out whether these vaccines are well-tolerated and infectious in HPIV3-seropositive children. The general procedures include daily temperature measurements and daily contact with the participant for the first 28 days, giving a single dose of one of the 2 study vaccines or placebo delivered by nasal sprayer, about 9 in-person visits, a physical examination, 7 clinical assessments, 2 blood samples, 9 nasal swabs and monthly contacts with the participant between Days 29-180. Additional visits may occur if the child has a respiratory illness, fever, or ear infections. The illness visit will include a nasal swab and a clinical assessment.
Trial Details
NCT Number NCT06546423
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: Johns Hopkins Bloomberg School of Public Health, Vanderbilt University Medical Center, University of Rochester
Conditions Human Metapneumovirus, Human Parainfluenza Virus Type 3
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov