Imovax Rabies Vaccine Description
Imovax Rabies is an inactivated vaccine made from an attenuated rabies virus.
It is a sterile, stable, freeze-dried suspension of Rabies Vaccine Inactivated virus prepared from WISTAR Rabies PM/WI 38 1503-3M strain.
Imovax Rabies Vaccine Indication
Imovax Rabies is a vaccine indicated for pre-exposure and post-exposure prophylaxis against rabies. Imovax Rabies vaccine is approved for use in all age groups.
Imovax Rabies Vaccine Dosage
Imovax Rabies is administered as an intramuscular injection containing no preservative. For adults and older children, Imovax Rabies vaccine should be administered in the deltoid 12 muscle. For infants and younger children, the anterolateral aspect of the thigh is also acceptable, 13 depending on age and body mass.
Imovax Rabies Vaccine Clinical Trials
Clinical Trial NCT02956746: A Comparison of the Safety, PD and PK of a Single Dose of SYN023 Administered With Licensed Rabies Vaccines (RabiesMab)
This is single site, randomized, blinded comparison of the immunogenicity, of Imovax (RVi) and Rabavert (RVa) rabies vaccines when subjects are administered rabies immune globulin (RIG) or SYN023.
Subjects will be randomized into one of four dose groups: RVi + SYN023, RVi+RIG, RVa+SYN023 and RVa+RIG.
The initial dose of RVi and RVa will be co-administered with either RIG or SYN023).
Rabies virus neutralizing activity (RVNA) and blood levels of SYN023 will be measured for the remainder of the trial while the rest of the five RVi and RVa doses are given.
The study will last 112 days. SYN023 concentrations and anti-SYN023 antibodies will also be measured.
Clinical Trial NCT01930357: Phase 2 Purified Vero Rabies Vaccine-Serum Free Compared to Human Diploid Cell Vaccine in a Pre-exposure Prophylaxis Regimen
To demonstrate that VRVg is non-inferior to Imovax® Rabies in terms of the proportion of subjects achieving a rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 international units (IU)/mL at D42, i.e. 14 days after the last vaccination.
To describe if at least 99% of subjects achieve an RVNA titer ≥ 0.5 IU/mL at D42 with a lower bound of the 95% confidence interval (CI) of at least 97%, in the VRVg group.