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

NCT00258947 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2012-02-01

No results posted yet for this study

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

Interventions

BIOLOGICAL

Smallpox vaccine, LISTER strain, from chick embryo cells

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2006-12-31
Completion
2007-01-31

Countries

  • France

Study Locations

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Entities

Diseases
Companies

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 NCT00258947 on ClinicalTrials.gov