A Long-Term Study of Healthy Adults Vaccinated With One Dose of Smallpox Vaccine (LISTER Strain)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Long-Term Safety and Immunogenicity Follow-up of Healthy Adults Vaccinated With One Dose of Smallpox Vaccine (LISTER Strain) |
- To provide information concerning the immune response of live vaccinia virus (LISTER strain) after primary vaccination. [ Time Frame: 1 to 5 years post-vaccination ] [ Designated as safety issue: No ]
- To provide information concerning the safety after primary administration of live vaccinia virus (LISTER strain). [ Time Frame: 1 to 5 years post-vaccination ] [ Designated as safety issue: Yes ]
| Enrollment: | 147 |
| Study Start Date: | October 2006 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Smallpox Vaccine (LISTER Strain) Group
Participants 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 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).
Eligibility| Ages Eligible for Study: | 18 Years to 25 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Participants were vaccinated with the second-generation smallpox vaccine in Study VVL04 (NCT 00258947)
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.
Contacts and Locations| France | |
| Gières, France, 38610 | |
| Lagord, France, 17140 | |
| Montpellier Cedex 5, France, 34094 | |
| Paris, France, 75015 | |
| Poitiers, France, 86000 | |
| Study Director: | Medical Monitor | Sanofi Pasteur Inc. |
More Information
Additional Information:
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00998543 History of Changes |
| Other Study ID Numbers: | VVL05 |
| Study First Received: | October 19, 2009 |
| Last Updated: | August 2, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Sanofi:
|
Smallpox Vaccinia Virus Smallpox Vaccine Variola Virus |
Additional relevant MeSH terms:
|
Smallpox Poxviridae Infections DNA Virus Infections Virus Diseases |
ClinicalTrials.gov processed this record on May 19, 2013