Rabies
Conditions
Keywords
rabies;, rabies post-exposure;, category III
Brief summary
* To demonstrate that rabies vaccine administered according to the Thai Red Cross, (TRC)-ID regimen (2-2-2-0-1-1) is not inferior to rabies vaccine administered according to the ESSEN IM regimen in terms of Geometric Mean Titers (GMTs) at D28, in subjects with a WHO category III rabies exposure,or, * To demonstrate that Rabies vaccine administered according to the ZAGREB-IM regimen (2-1-1) is not inferior to Rabies vaccine administered according to the ESSEN IM regimen in terms of GMTs at D28, in subjects with a WHO category III rabies exposure. Secondary objectives: 1. To describe the immunogenicity profile of each regimen 2. To assess the safety of the vaccine in each group.
Interventions
BIOLOGICALPurified Verocell Rabies Vaccine
0.1 mL, ID (TRC regimen)
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject with WHO category III rabies exposure * Subject aged at least 2 years old (day of second birthday)
Exclusion criteria
* Subject unable to comply with the follow-up schedule of the protocol * Delayed post-exposure treatment (\>72 hours between incident and treatment * Subject bitten by an observable animal at the inclusion visit * Subject with immune-compromised or underlying diseases which may lead to inferior immune response * Subject with known pregnancy at the time of inclusion * Subject enrolled or scheduled to be enrolled in another clinical study. * Subject with acute febrile illness/ axillary temperature \> 37.5 degree celsius * Subject in whom blood sampling will be difficult. * Subject receiving chloroquine or other anti-malarial treatment * Subject receiving immunosuppressive therapy, other immune-modifying drug or cytotoxic drugs * Subject with known chronic illnesses (ie. heart, lung, kidney, liver) including immunosuppressive diseases (cancer, HIV, etc.) * Previous rabies immunization * Subject having received any vaccine within the previous 30 days, except tetanus toxoid and tetanus immunoglobulin * Subject with clinical signs of rabies * Subject with known allergy to vaccine components (e.g. neomycin) * Subject who received blood and/or plasma transfusion within the past 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunogenicity: To provide information concerning the immune response of Purified Verocell Rabies Vaccine | 6 months post-vaccination |
Countries
India
Outcome results
None listed