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A Phase II Trial to Compare a Liquid-frozen and a Freeze-dried Formulation of IMVAMUNE (MVA-BN®) Smallpox Vaccine in Vaccinia-naïve Healthy Subjects

NCT01668537 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 651

Last updated 2020-10-12

Study results available
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Summary

A randomized, double-blind, multicenter Phase II trial to compare the immunogenicity and safety of a liquid-frozen and a freeze-dried formulation of IMVAMUNE (MVA-BN®) smallpox vaccine in vaccinia-naïve healthy subjects

Conditions

Interventions

BIOLOGICAL

LF formulation of IMVAMUNE®

BIOLOGICAL

FD formulation of IMVAMUNE®

Sponsors & Collaborators

  • Bavarian Nordic

    lead INDUSTRY

Principal Investigators

  • Richard N Greenberg, MD · University of Kentucky

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-01-31
Completion
2014-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01668537 on ClinicalTrials.gov