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NCT00998543 Clinical Trial

A Long-Term Study of Healthy Adults Vaccinated With One Dose of Smallpox Vaccine (LISTER Strain)

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00998543
Other study ID # VVL05
Secondary ID
Status Completed
Phase Phase 2
First received October 19, 2009
Last updated August 2, 2012
Start date October 2006
Est. completion date March 2012

Study information
Verified date August 2012
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Observational

Clinical Trial 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.

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).

Recruitment information / eligibility
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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

France, 

Outcome
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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