Prophylactic Immunization against Rabies
Conditions
Interventions
Trade Name: Verorab
Product Name: Purified Vero Rabies Vaccine - Serum Free (VRVg)
Product Code: 382
Pharmaceutical Form: Powder and solvent for suspension for injection
Current Sponsor code: 382
Othe
Sponsors
Sanofi Pasteur SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that VRVg (PR1) is at least as immunogenic as the reference vaccine, Verorab (PR2), in terms of seroconversion rate at D42, i.e. 14 days after the last vaccination of primary vaccination series. ;Secondary Objective: To assess the clinical safety of VRVg after each vaccination when administered in a pre-exposure vaccination schedule with a booster at 12 months after the first vaccination in all subjects. To describe the immune response induced by VRVg 21 days after two vaccinations (D28) in a subset of 120 randomized subjects and 14 days after the last vaccination of the primary vaccination series, i.e. at D42, in all subjects. To describe antibody persistence at 6 and 12 months after the first vaccination in all subjects. To describe the immune response induced by VRVg 14 days after a booster vaccination administered 12 months after the first vaccination in all subjects. ;Primary end point(s): Seroconversion status at D42: rabies virus neutralizing antibody (RVNA) titer = 0.5 IU/mL by RFFIT. | — |
Countries
France
Outcome results
None listed