A Long-Term Study of Healthy Adults Vaccinated With One Dose of Smallpox Vaccine (LISTER Strain)
|ClinicalTrials.gov Identifier: NCT00998543|
Recruitment Status : Completed
First Posted : October 20, 2009
Last Update Posted : August 6, 2012
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).
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.
|Condition or disease||Phase|
|Study Type :||Observational|
|Actual Enrollment :||147 participants|
|Official Title:||A Long-Term Safety and Immunogenicity Follow-up of Healthy Adults Vaccinated With One Dose of Smallpox Vaccine (LISTER Strain)|
|Study Start Date :||October 2006|
|Primary Completion Date :||September 2011|
|Study Completion Date :||March 2012|
Smallpox Vaccine (LISTER Strain) Group
Participants were vaccinated with the second-generation smallpox vaccine in Study VVL04 (NCT 00258947).
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00998543
|Gières, France, 38610|
|Lagord, France, 17140|
|Montpellier Cedex 5, France, 34094|
|Paris, France, 75015|
|Poitiers, France, 86000|
|Study Director:||Medical Monitor||Sanofi Pasteur Inc.|