- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00998543
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Gières, France, 38610
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Lagord, France, 17140
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Montpellier Cedex 5, France, 34094
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Paris, France, 75015
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Poitiers, France, 86000
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Smallpox Vaccine (LISTER Strain) Group
Participants were vaccinated with the second-generation smallpox vaccine in Study VVL04 (NCT 00258947).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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To provide information concerning the immune response of live vaccinia virus (LISTER strain) after primary vaccination.
Time Frame: 1 to 5 years post-vaccination
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1 to 5 years post-vaccination
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To provide information concerning the safety after primary administration of live vaccinia virus (LISTER strain).
Time Frame: 1 to 5 years post-vaccination
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1 to 5 years post-vaccination
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VVL05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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