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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 147 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 25 Years
• Healthy volunteers: Accepted

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).

Conditions

• Smallpox

Timeline

• Start date: 2006-10-01
• Primary completion: 2011-09-01
• Completion: 2012-03-01
• First posted: 2009-10-20
• Last updated: 2012-08-06

Locations

5 sites across 1 country: France