A Long-Term Study of Healthy Adults Vaccinated With One Dose of Smallpox Vaccine (LISTER Strain)

August 2, 2012 updated by: Sanofi

A Long-Term Safety and Immunogenicity Follow-up of Healthy Adults Vaccinated With One Dose of Smallpox Vaccine (LISTER Strain)

The purpose of this study is to provide long-term follow-up immunogenicity and safety data on participants who were vaccinated with the second-generation smallpox vaccine in Study VVL04 (NCT 00258947).

Primary Objectives:

Immunogenicity: To yearly describe the vaccinia antibody persistence up to 5 years post-vaccination.

Safety: To follow-up the long-term safety up to 5 years post-vaccination.

Study Overview

Status

Completed

Conditions

Detailed Description

None of the participants in this study will receive any vaccination as part of the study. All participants will provide blood samples for immunogenicity testing at the 1, 2, 3, 4, and 5 year anniversaries of vaccination. Safety will be assessed for up to 5 years after vaccination, including follow-up of reactions that occurred during Study VVL04 (NCT 00258947).

Study Type

Observational

Enrollment (Actual)

147

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Gières, France, 38610
      • Lagord, France, 17140
      • Montpellier Cedex 5, France, 34094
      • Paris, France, 75015
      • Poitiers, France, 86000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants were vaccinated with the second-generation smallpox vaccine in Study VVL04 (NCT 00258947)

Description

Inclusion Criteria :

  • Subject vaccinated and who completed the Phase II VVL04 trial.
  • Informed consent form signed.
  • Subject able to comply with all trial procedures.
  • Subject entitled to national social security.

Exclusion Criteria :

  • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Smallpox Vaccine (LISTER Strain) Group
Participants were vaccinated with the second-generation smallpox vaccine in Study VVL04 (NCT 00258947).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To provide information concerning the immune response of live vaccinia virus (LISTER strain) after primary vaccination.
Time Frame: 1 to 5 years post-vaccination
1 to 5 years post-vaccination
To provide information concerning the safety after primary administration of live vaccinia virus (LISTER strain).
Time Frame: 1 to 5 years post-vaccination
1 to 5 years post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

October 19, 2009

First Submitted That Met QC Criteria

October 19, 2009

First Posted (Estimate)

October 20, 2009

Study Record Updates

Last Update Posted (Estimate)

August 6, 2012

Last Update Submitted That Met QC Criteria

August 2, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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