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

Sponsor:	Sanofi-Aventis
Information provided by (Responsible Party):	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00998543

Purpose

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.

Condition	Phase
Smallpox	Phase 2

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	A Long-Term Safety and Immunogenicity Follow-up of Healthy Adults Vaccinated With One Dose of Smallpox Vaccine (LISTER Strain)

Resource links provided by NLM:

MedlinePlus related topics: Smallpox

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

To provide information concerning the immune response of live vaccinia virus (LISTER strain) after primary vaccination. [ Time Frame: 1 to 5 years post-vaccination ] [ Designated as safety issue: No ]
To provide information concerning the safety after primary administration of live vaccinia virus (LISTER strain). [ Time Frame: 1 to 5 years post-vaccination ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	230
Study Start Date:	October 2006
Estimated Study Completion Date:	March 2012
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

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

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).

Eligibility

Ages Eligible for Study:	18 Years to 25 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00998543

Locations

France

Gières, France, 38610

Lagord, France, 17140

Montpellier Cedex 5, France, 34094

Paris, France, 75015

Poitiers, France, 86000

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Medical Monitor

Sanofi Pasteur Inc.

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00998543 History of Changes
Other Study ID Numbers:	VVL05
Study First Received:	October 19, 2009
Last Updated:	January 3, 2012
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Sanofi-Aventis:

Smallpox Vaccinia Virus Smallpox Vaccine Variola Virus

Additional relevant MeSH terms:

Smallpox
Poxviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 24, 2012