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Open-label, Multicenter Immunogenicity and Safety Study of MVA-BN Vaccine in Children From 2 Years to Less Than 12 Years of Age Compared to Adults for the Prevention of Smallpox, Mpox, and Related Orthopoxvirus Infections

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 24, 2025 (before its estimated May 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Jun 12, 2025 to May 1, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 3 of 3 sites
    • Eligibility criteria expanded, about 4 words
    v5
  2. Study sites revised (3)v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Start date changed from estimate of Oct 16, 2024 to Oct 21, 2024
    • Secondary endpoints expanded, about 7 words
    v3
  4. Primary endpoints revised (2)
    • Eligibility criteria expanded, about 11 words
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
All participants will receive 2 vaccinations of the same dose of Modified Vaccinia Ankara Virus (MVA-BN) vaccine 4 weeks apart (standard regimen). Serum samples for assessment of immune response will be collected at baseline (visit of first vaccination) and at 2 weeks (week 6), 6 months (week 30), and 1 year after the second (last) vaccination.
Trial Details
NCT Number NCT06549530
Lead Sponsor Bavarian Nordic
Collaborators: Coalition for Epidemic Preparedness Innovations
Conditions
(from sponsor)		 Monkeypox (Mpox)
Related terms Mpox, Monkeypox
Enrollment 460 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov