A Long-Term Safety and Immunogenicity Follow-up of Healthy Adults Vaccinated With One Dose of Smallpox Vaccine (LISTER Strain)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Smallpox
- Sponsor
- Sanofi
- Enrollment
- 147
- Primary Endpoint
- To provide information concerning the immune response of live vaccinia virus (LISTER strain) after primary vaccination.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief 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.
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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