Status:
COMPLETED
Evaluation of Take and Safety of a Smallpox Vaccine in Healthy Young Adults
Lead Sponsor:
Sanofi
Conditions:
Smallpox
Poxvirus Infection
Eligibility:
All Genders
18-25 years
Phase:
PHASE2
Brief Summary
Primary Objective: To estimate the smallpox vaccination take rate in healthy young adults not previously vaccinated with a smallpox vaccine. Secondary Objectives: To describe antibody response to v...
Eligibility Criteria
Inclusion
- Aged 18 to 25 years on the day of screening
- Informed consent form signed
- Able to attend all scheduled visits and to comply with all trial procedures
- For a woman, inability to bear a child or negative serum pregnancy test performed at screening (Visit 01)
- Subject entitled to national social security
- Subject registered in the French file of healthy volunteers in clinical trials
- For a woman of child-bearing potential: use of an effective method of contraception (hormonal or barrier method) from at least 3 months prior to screening to 3 months following trial vaccination
- For a woman, inability to bear a child or negative urine pregnancy test.
Exclusion
- Previous smallpox vaccination confirmed by vaccination record or typical scar
- Participation in another trial in the 3 months before or during the trial period
- Acute intercurrent or chronic illness during the trial
- Breast-feeding
- Allergy or sensitivity to any known components of vaccinia immune globulin or previous reaction to immunoglobulins or trial vaccine
- Congenital or acquired immunodeficiency or immunosuppressive therapy or any treatment including corticosteroids
- Treatment with antiviral drugs within 1 month before vaccination
- History of organ or bone marrow transplant or skin disorders
- Personal or family history of autoimmune disease or cardiac disease, including cardiac risk factors
- History or current central nervous system disease
- Ongoing acute infectious disease
- Blood or blood-derived products received in the past 6 months
- Any vaccination with a live-attenuated vaccine within the 60 days or other vaccines within 40 days preceding the trial vaccination
- Vaccination planned in the 8 weeks following the trial vaccination
- Planned or foreseeable close contact after vaccination with infants less than 12 months, or with immuno-suppressed persons, pregnant and/or lactating woman, or practice of contact or water sports after vaccination before the crust separates
- Skin wound near the vaccination site
- Apparent lack of personal hygiene
- Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
- HIV, hepatitis B or hepatitis C seropositivity (screening tests)
- Abnormal lab values for hematological parameters or cardiac enzyme (screening tests)
- Feverish illness (oral temperature \>=37.5°C, rectal equivalent temperature \>=38.0°C) on the day of vaccination.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT00258947
Start Date
September 1 2005
End Date
January 1 2007
Last Update
February 1 2012
Active Locations (6)
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1
Gières, France
2
Lagord, France
3
Montpellier, France
4
Paris, France