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

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ClinicalTrials.gov Identifier: NCT00998543
Recruitment Status : Completed
First Posted : October 20, 2009
Last Update Posted : August 6, 2012
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

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 or disease
Smallpox

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
Actual Enrollment : 147 participants
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)
Study Start Date : October 2006
Actual Primary Completion Date : September 2011
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smallpox
U.S. FDA Resources

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



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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00998543


Locations
France
Gières, France, 38610
Lagord, France, 17140
Montpellier Cedex 5, France, 34094
Paris, France, 75015
Poitiers, France, 86000
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Medical Monitor Sanofi Pasteur Inc.

Additional Information:
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00998543     History of Changes
Other Study ID Numbers: VVL05
First Posted: October 20, 2009    Key Record Dates
Last Update Posted: August 6, 2012
Last Verified: August 2012

Keywords provided by Sanofi:
Smallpox Vaccinia Virus Smallpox Vaccine Variola Virus

Additional relevant MeSH terms:
Smallpox
Poxviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs