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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00998543
First received: October 19, 2009
Last updated: August 2, 2012
Last verified: August 2012
  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:


Further study details as provided by Sanofi:

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 ]

Enrollment: 147
Study Start Date: October 2006
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Study Director: Medical Monitor Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00998543     History of Changes
Other Study ID Numbers: VVL05
Study First Received: October 19, 2009
Last Updated: August 2, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Sanofi:
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 August 19, 2014