Freeze-Dried MVA-BN® Lot Consistency Smallpox Trial

Status Completed

Clinical Trial Summary

This is a Phase 3 multicenter trial to evaluate safety and immune response of three consecutive production lots of freeze-dried (FD) MVA-BN smallpox vaccine. The vaccine will be given to healthy subjects who do not have a smallpox scar. Approximately 1110 subjects will be randomly enrolled into one of three groups: Group 1 will include 370 subjects, who will receive two separate injections (shot) with a short needle, given below the skin of the upper arm with 0.5 mL FD MVA-BN (Lot 1). Group 2 will include 370 subjects, who will receive two separate injections (shot) with a short needle, given below the skin of the upper arm with 0.5 mL FD MVA-BN (Lot 2). Group 3 will include 370 subjects, who will receive two separate injections (shot) with a short needle, given below the skin of the upper arm with 0.5 mL FD MVA-BN (Lot 3). The primary objective of the trial is to show that the immune response elicited (produced) by three consecutively produced MVA-BN lots are statistically (numerically) comparable.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Smallpox

Clinical Trial Details

NCT number	NCT03699124
Study type	Interventional
Source	Bavarian Nordic
Contact
Status	Completed
Phase	Phase 3
Start date	June 19, 2019
Completion date	June 22, 2020

View Details

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