NCT00258947

Evaluation of Take and Safety of a Smallpox Vaccine in Healthy Young Adults

Take Evaluation and Safety of Smallpox Vaccine (LISTER Strain) in Naïve Healthy Adults.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 25 Years
• Healthy volunteers: Accepted

Summary

Primary Objective: To estimate the smallpox vaccination take rate in healthy young adults not previously vaccinated with a smallpox vaccine. Secondary Objectives: To describe antibody response to vaccination and evaluate the take for each subject at various timepoints for each batch and pooled batches and to evaluate local signs, symptoms, and overall safety in healthy young adults not previously vaccinated with a smallpox vaccine.

Conditions

• Smallpox
• Poxvirus Infection

Interventions

Type	Name	Description
BIOLOGICAL	Smallpox vaccine, LISTER strain, from chick embryo cells

Timeline

• Start date: 2005-09-01
• Primary completion: 2006-12-01
• Completion: 2007-01-01
• First posted: 2005-11-28
• Last updated: 2012-02-01

Locations

6 sites across 1 country: France