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Study of an RSV-hMPV-PIV3 Trivalent Vaccine Candidate VXB-251 in Older Adults

Study acronym: VXB251-001
StatusActive, Not Recruiting
PhasePhase 1
SponsorSanofi
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Notable Sponsor changed: Vicebio Australia Proprietary Limited to Sanofi
    • Eligibility criteria expanded, about 20 words
    v3
  2. Minor Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of May 24, 2026 to Apr 21, 2026
    • Site details revised at 6 of 6 sites
    v2
  3. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
284 trials monitored
See 12 trials at risk
This study is being done to find out how safe and effective a new combined vaccine candidate, called VXB-251, is for older adults. The vaccine candidate is designed to protect against three common viruses that can cause respiratory tract infections: * RSV (respiratory syncytial virus) * hMPV (human metapneumovirus) * PIV3 (parainfluenza virus type 3) Two components of this vaccine (RSV and hMPV) have already been tested in people before, as part of another study for a two-in-one vaccine. However, this is the first time that the PIV3 component and all three components together (RSV, hMPV, and PIV3) are being tested in people. The vaccine candidate will be given as a single intramuscular injection. The study will also test unlicensed comparator vaccines and a placebo (a substance that looks like the real vaccine but doesn't contain any active ingredients) that target none, one or two of these viruses to see whether combining all three components affects safety or how well the immune system responds.
Trial Details
NCT Number NCT07295028
Lead Sponsor Sanofi
Conditions
(from sponsor)
Lower Respiratory Tract Disease, Healthy Participants
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov