Smallpox Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 147 |
Est. completion date | March 2012 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 25 Years |
Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To provide information concerning the immune response of live vaccinia virus (LISTER strain) after primary vaccination. | 1 to 5 years post-vaccination | No | |
Primary | To provide information concerning the safety after primary administration of live vaccinia virus (LISTER strain). | 1 to 5 years post-vaccination | Yes |
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