A Long-Term Safety and Immunogenicity Follow-up of Healthy Adults Vaccinated with One Dose of Smallpox Vaccine (LISTER Strain).
Phase 1
- Conditions
- Five year follow-up of healthy adults already vaccinated in a previous trial
- Registration Number
- EUCTR2006-000715-19-FR
- Lead Sponsor
- Sanofi Pasteur SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 230
Inclusion Criteria
1) Subject vaccinated and who completed the Phase II VVL04 trial.
2) Informed consent form signed.
3) Subject able to attend all scheduled visits and to comply with all trial procedures.
4) Subject entitled to national social security.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1) Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method