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A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in Africa

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site details revised at 1 of 6 sitesv5
  2. Site details revised at 2 of 6 sitesv4
  3. Site details revised at 1 of 6 sitesv3
  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Feb 2026 to Feb 20, 2026 · Site details revised at 6 of 6 sitesv2 Show 2 more changesShow less
    • Start date changed from estimate of Feb 2026 to Feb 20, 2026
    • Site details revised at 6 of 6 sites
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
BioNTech SE
49 trials monitored
See 3 trials at risk
This is a randomized, double-blind, placebo-controlled study which aims to assess the safety, reactogenicity, and immunogenicity after one and two doses of BNT166a or placebo in healthy participants.
Trial Details
NCT Number NCT07379580
Lead Sponsor BioNTech SE
Collaborators: Coalition for Epidemic Preparedness Innovations
Conditions Mpox (Monkeypox), Smallpox, Orthopoxvirus Infection
Enrollment 310 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov