Clinical Trial

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

Active, Not Recruiting Phase 2
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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.
Summary
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-08-07; most recent amendment 2025-11-19.
Status change: Recruiting → Active, Not Recruiting 2025-11-19
Status change: Not Yet Recruiting → Recruiting 2024-12-10
Trial Details
NCT Number NCT06549530
Lead Sponsor Bavarian Nordic
Collaborators: Coalition for Epidemic Preparedness Innovations
Conditions Monkeypox (Mpox)
Enrollment 460 participants
Start Date 2024-10-21
Primary Completion 2026-05-01 (estimated)
Study Completion 2026-05-07 (estimated)
Updated on ClinicalTrials.gov 2025-11-24