At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 435 enrolled

Drug / intervention

MVA Smallpox Vaccinebiological

Likely dose

MVA Smallpox Vaccine 0.5 mLfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01827371

NCT01827371Phase 2Completed

Compare CT.gov

A Phase II, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of IMVAMUNE® Using Three Immunization Schedules and Two Modes of Delivery

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Apr 9, 2013·Updated Sep 7, 2016

In Brief

A Phase 2 clinical trial evaluating MVA Smallpox Vaccine for Smallpox. Completed, enrolled 435 participants across 6 sites.

Detailed Summary

Imvamune (licensed name of MVA being developed as a smallpox vaccine) has been tested in over 2,000 individuals and is on path for licensure. This study will be a Phase II to evaluate three different immunization schedules and two different modes of delivery. The study will look at condensed schedules. Study will randomize subjects to one of four arms.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsSmallpox

CountriesUnited States

Collaborators--

Timeline

Phase 2CompletedFinished

20132014201520162017201820192020202120222023202420252026

First PostedApr 2013

Enrollment StartJun 2013

Primary CompletionApr 2015

TodayJul 2026

First PostedApr 9, 2013

Enrollment StartJun 1, 2013

Primary CompletionApr 1, 2015

TodayJul 2, 2026

Enrollment to primary: 1.8 yearsPosted 13.2 years ago

Interventions

MVA Smallpox Vaccinebiological

Subjects receive two dose regimen of IMVAMUNE® (1x10\^8 TCID50/0.5 mL per dose) via the SC route using either a syringe and needle or the Stratis™ system. Arm A receives doses via syringe and needle on days 1 and 29; Arm B receives doses via syringe and needle on days 1 and 15, Arm C receives doses via syringe and needle on days 1 and 22, Arm D receives doses via Stratis on days 1 and 29.