Safety of Rabivax-S for Pre-exposure Prophylaxis

PHASE4CompletedINTERVENTIONAL
Enrollment

159

Participants

Timeline

Start Date

October 24, 2018

Primary Completion Date

March 28, 2019

Study Completion Date

March 28, 2019

Conditions
Rabies Vaccine Adverse Reaction
Interventions
BIOLOGICAL

Rabivax-S

Rabivax-S is a lyophilized vaccine manufactured by Serum Institute of India Pvt. Ltd. containing inactivated purified rabies antigen (Pitman Moore, PM3218 as virus strain) produced using Vero ATCC CCL 81 cells. The diluent (sterile water for injection) is provided in a separate 1 mL ampoule. After reconstitution, a single dose of 1 mL contains an inactivated, purified rabies antigen (not less than 2.5 IU), glycine (40 mg), sucrose (40 mg) and human serum albumin (25% 10 mg). The intervention is administered by intramuscular injection of 1 mL reconstituted vaccine in the deltoid area of the upper arm, on days 0, 7 and 21 (or 28).

Trial Locations (1)

Unknown

Ross University School of Veterinary Medicine, Basseterre

All Listed Sponsors
collaborator

Serum Institute of India Pvt. Ltd.

INDUSTRY

lead

Ross University School of Veterinary Medicine

OTHER

NCT03741270 - Safety of Rabivax-S for Pre-exposure Prophylaxis | Biotech Hunter | Biotech Hunter