Immunogenicity and Safety of a Purified Vero Rabies Vaccine
Condition: Rabies Virus
MeSH terms: Rabies
Intervention: VRVg 2; VRVg 1; Imovax Rabies; VRVg 2; VRVg 2; Human Rabies Immunoglobulins (HRIG)
Intervention description: Modified formulation 1 (Low) of Purified Vero Rabies Vaccine Serum Free; Initial formulation of Purified Vero Rabies Vaccine Serum Free; Purified inactivated rabies vaccine prepared on human diploid cell cultures; Modified formulation 2 (Medium) of Purified Vero Rabies Vaccine Serum Free; Modified formulation 3 (High) of Purified Vero Rabies Vaccine Serum Free; Commercialized formulation of HRIG
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 320.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Rabies virus

Summary:

      This multicenter, observer-blind, controlled, randomized, Phase II study was designed to
      evaluate different formulations of the Purified Vero Rabies Cell vaccine VRVg.
    

Eligibility criteria:

        Inclusion Criteria:

        An individual must fulfill all of the following criteria in order to be eligible for trial
        enrollment:

          1. Aged 18 to less than 65 years on the day of inclusion.

          2. Informed consent form had been signed and dated.

          3. Able to attend all scheduled visits and to complied with all trial procedures.

          4. Body Mass Index (BMI): 18.5 kilograms per meter square (Kg/m^2) less than or equal to
             (<=) BMI <= 30 Kg/m^2.

        Exclusion Criteria:

        An individual fulfilling any of the following criteria was to be excluded from trial
        enrollment:

          1. Participant was pregnant, or lactating, or of childbearing potential and not using an
             effective method of contraception or abstinence from at least 4 weeks prior to the
             first vaccination until at least 4 weeks after the last vaccination. To be considered
             of non-childbearing potential, a female must be post-menopausal for at least 1 year,
             or surgically sterile.

          2. Participation at the time of study enrollment or, planned participation during the
             present trial period in another clinical trial investigating a vaccine, drug, medical
             device, or medical procedure.

          3. Receipt of any vaccine in the 4 weeks (28 days) preceding the first trial vaccination
             or planned receipt of any vaccine prior to Visit 6.

          4. Previous vaccination against rabies (in pre- or post-exposure regimen) with either the
             trial vaccine or another vaccine.

          5. Receipt of immune globulins, blood or blood-derived products in the past 3 months.

          6. Known or suspected congenital or acquired immunodeficiency; or receipt of
             immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy,
             within the preceding 6 months; or long-term systemic corticosteroid therapy
             (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).

          7. At high risk for rabies infection during the trial (e.g., veterinarians and staff,
             animal handlers, rabies researchers, or any others whose activities may bring them
             into frequent contact with rabies virus or animals who had the rabies virus).

          8. Known systemic hypersensitivity to any of the vaccine or human rabies immunoglobulins
             (HRIG) components, or history of a life-threatening reaction to the vaccines used in
             the trial or to a vaccine containing any of the same substances.

          9. Self-reported thrombocytopenia, contraindicating IM vaccination.

         10. Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
             contraindicating IM vaccination.

         11. Deprived of freedom by an administrative or court order, or in an emergency setting,
             or hospitalized involuntarily.

         12. Current alcohol abuse or drug addiction.

         13. Chronic illness that, in the opinion of the investigator, was at a stage where it
             might interfere with trial conduct or completion (e.g., cardiac disorders, renal
             disorders, auto immune disorders, diabetes, psychiatric disorders or chronic
             infection).

         14. Moderate or severe acute illness/infection (according to investigator judgment) on the
             day of vaccination or febrile illness (temperature greater than or equal to [>=] 100.4
             Fahrenheit >=38.0 Celsius). A prospective participant should not be included in the
             study until the condition had resolved or the febrile event had subsided.

         15. Identified as an Investigator or employee of the Investigator or study center with
             direct involvement in the proposed study, or identified as an immediate family member
             (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with
             direct involvement in the proposed study.

         16. History of Guillain-Barré syndrome.