Immunogenicity of the Purified Vero Rabies Vaccine – Serum Free in Comparison with the Reference Purified Vero Rabies Vaccine in Pre-exposure Use in Healthy Adults
- Conditions
- Prophylactic Immunization against Rabies
- Registration Number
- EUCTR2009-009877-85-FR
- Lead Sponsor
- Sanofi Pasteur SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 385
1) Aged 18 to 60 years on the day of inclusion
2) Provision of a signed Informed Consent Form
3) Able to attend all scheduled visits and comply with all trial procedures
4) For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence for at least 4 weeks prior to each vaccination, until at least 4 weeks after each vaccination)
5) Entitlement 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
1) For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test
2) Breast-feeding woman
3) Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
4) Planned participation in another clinical trial during the present trial period
5) Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
6) Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
7) Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
8) Current alcohol abuse or drug addiction that may interfere with the subject’s ability to comply with trial procedures
9) Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
10) Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
11) Planned receipt of any vaccine in the 4 weeks following any trial vaccination
12) Known human immunodeficiency virus (HIV), HBs antigen, or Hepatitis C seropositivity
13) Previous vaccination against rabies with any vaccine (in pre-or post-exposure regimen)
14) Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
15) Subject at high risk for rabies exposure during the trial period
16) Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
17) Febrile illness (temperature =38.0°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment.
18) Study site employee who is involved in the protocol and may have direct access to trial-related data
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