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Trial record 1 of 1 for:    VVL05
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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

Tracking Information
First Submitted Date October 19, 2009
First Posted Date October 20, 2009
Last Update Posted Date August 6, 2012
Study Start Date October 2006
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 19, 2009)
  • To provide information concerning the immune response of live vaccinia virus (LISTER strain) after primary vaccination. [ Time Frame: 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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00998543 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Long-Term Study of Healthy Adults Vaccinated With One Dose of Smallpox Vaccine (LISTER Strain)
Official Title A Long-Term Safety and Immunogenicity Follow-up of Healthy Adults Vaccinated With One Dose of Smallpox Vaccine (LISTER Strain)
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.

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants were vaccinated with the second-generation smallpox vaccine in Study VVL04 (NCT 00258947)
Condition Smallpox
Intervention Not Provided
Study Groups/Cohorts Smallpox Vaccine (LISTER Strain) Group
Participants were vaccinated with the second-generation smallpox vaccine in Study VVL04 (NCT 00258947).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 2, 2012)
147
Original Estimated Enrollment
 (submitted: October 19, 2009)
230
Actual Study Completion Date March 2012
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 25 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT00998543
Other Study ID Numbers VVL05
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Sanofi
Study Sponsor Sanofi
Collaborators Not Provided
Investigators
Study Director: Medical Monitor Sanofi Pasteur Inc.
PRS Account Sanofi
Verification Date August 2012