MedDRA version: 20.0 Level: PT Classification code 10037742 Term: Rabies System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: VRVg
Product Code: 382
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Inactivated Rabies Virus (Wistar Pitman Moore/WI 38 1503-3M strain produc
Sponsors
Sanofi Pasteur SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Men or women aged =18 years on the day of inclusion (= 18 years means from the day of the 18th birthday onwards, with no upper age limit). - Able to attend all scheduled visits and to comply with all trial procedures. - Body Mass Index (BMI): 18.5 Kg/m2 = BMI = 30 Kg/m2. 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 479 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: - Subject is 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. - 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. - Receipt of any vaccine in the 4 weeks (28 days) preceding the first trial vaccination or planned receipt of any vaccine prior to Visit 7. - Previous vaccination against rabies (in pre- or post-exposure regimen) with either the trial vaccines or another vaccine. -Receipt of immune globulins, blood or blood-derived products in the past 3 months. - 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). - At high risk for rabies exposure during the trial (veterinarians and their staff, animal handlers, rabies researchers, and certain laboratory workers, persons whose activities bring them into frequent contact with rabies virus or potentially rabid bats, raccoons, skunks, cats, dogs, or other species at risk for having rabies, people travelling where rabies is enzootic). - Known systemic hypersensitivity to any of the vaccine or 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. - Self-reported thrombocytopenia, contraindicating IM vaccination. - Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination. - Current alcohol or substance abuse that, in the opinion of the investigator, might interfere with the trial conduct of completion. - Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion. - Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature = 38.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided. - Personal history of Guillain-Barré syndrome. - 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 (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that Vero Rabies Vaccine generation 2 (VRVg-2) is non-inferior to Verorab and Imovax Rabies vaccines when co-administered with Human Rabies Immunoglobulins (HRIG), in terms of proportion of subjects achieving a RVNA titer = 0.5 IU/mL at D28, ie, 14 days after the fourth vaccine injection. ;Secondary Objective: - To describe the safety profile of VRVg-2 versus Verorab and Imovax Rabies vaccines when co-administered with HRIG, as well as that of VRVg-2, after each vaccine injection. - To demonstrate that the proportion of subjects in the VRVg-2 + HRIG group achieving an RVNA titer = 0.5 IU/mL at D28 is at least 95%. - To describe the immune response induced by VRVg-2 versus Verorab and Imovax Rabies vaccines when co-administered with HRIG, as well as that induced by VRVg-2, at D14 (7 days after the third injection), at D28 (14 days after the fourth injection) and at D42 (14 days after the last injection). ;Primary end point(s): Rabies Virus Neutralizing Antibodies (RVNA) Titers >=0.5 IU/mL : Percentage of participants achieving RVNA Titer >=0.5 IU/mL as measured by the rapid fluorescent focus inhibition test (RFFIT) assay ;Timepoint(s) of evaluation of this end point: Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1- Occurrence of solicited injection site and systemic reactions: Percentage of paritcipants reporting solicited injection site reactions (pain, erythema, and swelling) and systemic reactions (fever, headache, malaise, myalgia) 2- RVNA Titers: Geometric Mean Titers (GMTs) of RVNA 3- RVNA Titers >=0.5 IU/mL: Percentage of participants achieving RVNA Titer >=0.5 IU/mL as measured by the RFFIT assay 4- RVNA titer = Lower Limit Of Quantitation (LLOQ) IU/mL:Percentage of participants with an RVNA titer = LLOQ 5- RVNA titer ratio:Individual Geometric Mean Titer Ratio (GMTR): (post-/pre-vaccination) 6- Virus neutralization: Percentage of participants with complete or incomplete neutralization at the starting dilution (1/5) of the RFFIT assay ;Timepoint(s) of evaluation of this end point: 1- Within 7 days post-vaccination 2- Day 0, Day 14, Day 28 and Day 42 3- Day 0, Day 14, Day 28 and Day 42 4- Day 0, Day 14, Day 28 and Day 42 5- Day 0, Day 14, Day 28 and Day 42 6- Day 0, Day 14, Day 28 and Day 42 | — |
Countries
France
Contacts
Public ContactDirection des Opérations Cliniques
sanofi-aventis France
Outcome results
None listed