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

October 19, 2009
August 2, 2012
October 2006
September 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00998543 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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A Long-Term Study of Healthy Adults Vaccinated With One Dose of Smallpox Vaccine (LISTER Strain)
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.

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).

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

Smallpox
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Smallpox Vaccine (LISTER Strain) Group
Participants were vaccinated with the second-generation smallpox vaccine in Study VVL04 (NCT 00258947).
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
147
March 2012
September 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 25 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00998543
VVL05
No
Sanofi
Sanofi
Not Provided
Study Director: Medical Monitor Sanofi Pasteur Inc.
Sanofi
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP