Status:
COMPLETED
A Long-Term Study of Healthy Adults Vaccinated With One Dose of Smallpox Vaccine (LISTER Strain)
Lead Sponsor:
Sanofi
Conditions:
Smallpox
Eligibility:
All Genders
18-25 years
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)...
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 anniversa...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT00998543
Start Date
October 1 2006
End Date
March 1 2012
Last Update
August 6 2012
Active Locations (5)
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1
Gières, France, 38610
2
Lagord, France, 17140
3
Montpellier, France, 34094
4
Paris, France, 75015