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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

NCT06549530 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2025-11-24

No results posted yet for this study

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.

Conditions

  • Monkeypox (Mpox)

Interventions

DRUG

MVA-BN

All participants will receive 2 vaccinations of the same dose of MVA-BN vaccine 4 weeks apart (standard regimen).

Sponsors & Collaborators

  • Coalition for Epidemic Preparedness Innovations

    collaborator OTHER

  • Bavarian Nordic

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-21
Primary Completion
2026-05-01
Completion
2026-05-07
FDA Drug
Yes

Countries

  • Democratic Republic of the Congo
  • Uganda

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06549530 on ClinicalTrials.gov