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Clinical Trials/NCT01668537
NCT01668537
Completed
Phase 2

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

Bavarian Nordic3 sites in 1 country651 target enrollmentMarch 2013
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ConditionsSmallpox

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Smallpox
Sponsor
Bavarian Nordic
Enrollment
651
Locations
3
Primary Endpoint
ELISA GMT
Status
Completed
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief 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

Registry
clinicaltrials.gov
Start Date
March 2013
End Date
June 2014
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

ELISA GMT

Time Frame: Week 6

Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Titers below the detection limit are included with a value of '1'

Secondary Outcomes

  • ELISA GMTs(within 8 weeks)
  • Number of Participants With Adverse Events of Special Interest (AESI)(up to 32 weeks)
  • Number of Participants With Serious Adverse Events(up to 32 weeks)
  • PRNT GMT(Week 6)
  • PRNT GMTs(within 8 weeks)
  • ELISPOT Magnitudes of Response(within 8 weeks)
  • Percentage of Participants With Response by ELISPOT(within 8 weeks)
  • Percentage of Responders by ELISPOT(within 8 weeks)
  • Correlation ELISA vs PRNT Titers(within 8 weeks)
  • Number of Participants With Related Grade >=3 Adverse Events(within 29 days after vaccination)
  • Number of Participants With Solicited Local Averse Events(8 days after any vaccination)
  • Percentage of Participants With Seroconversion by PRNT(within 8 weeks)
  • Number of Participants With Solicited General Adverse Events(within 8 days after any vaccination)
  • Percentage of Participants With Seroconversion by ELISA(within 8 weeks)
  • Number of Participants With Unsolicited Adverse Events(within 29 days after vaccination)

Study Sites (3)

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