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MVA-BN-RSV Vaccine Trial

NCT05238025 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20419

Last updated 2024-10-31

Study results available
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Summary

Phase 3 randomized, double blind study comparing recombinant MVA-BN-RSV vaccine vs placebo for efficacy and safety in adults \>=60 years of age

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

BIOLOGICAL

MVA-BN-RSV vaccine

One injection, suspension for injection, intramuscular use, 0.5mL MVA-BN-RSV virus with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL in a Tris buffer at pH 7.7.

BIOLOGICAL

Tris Buffered Saline (TBS)

One injection, solution for injection, intramuscular use, 0.5mL TBS, pH 7.7.

Sponsors & Collaborators

  • Bavarian Nordic

    lead INDUSTRY

Principal Investigators

  • Bernard Hoet, MD · Bavarian Nordic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-19
Primary Completion
2023-06-29
Completion
2023-09-01
FDA Drug
Yes

Countries

  • United States
  • Germany

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 NCT05238025 on ClinicalTrials.gov