SII Rabivax (rabies vaccine) / Serum Institute of India - LARVOL DELTA

Post-exposure prophylaxis regimen of rabies monoclonal antibody and vaccine in category 3 potential exposure patients: a phase 4, open-label, randomised, active-controlled trial. (PubMed, Lancet) - "RmAb was safe and well tolerated and showed protective efficacy against rabies. A PEP regimen containing RmAb plus PVRV was immunogenic with long-term persistence of immune response."

Clinical • Journal • P4 data

Safety and efficacy of malaria vaccine candidate R21/Matrix-M in African children: a multicentre, double-blind, randomised, phase 3 trial. (PubMed, Lancet) - P3 | "R21/Matrix-M was well tolerated and offered high efficacy against clinical malaria in African children. This low-cost, high-efficacy vaccine is already licensed by several African countries, and recently received a WHO policy recommendation and prequalification, offering large-scale supply to help reduce the great burden of malaria in sub-Saharan Africa."

Journal • P3 data • Infectious Disease • Malaria • Pain

Results from a phase III trial evaluating the R21/Matrix-M malaria vaccine (ASTMH 2023) - "All participants were randomised 2:1, R21/MM: control rabies vaccine. Ltd have committed to large-scale manufacturing and supply. High-level efficacy of this vaccine, combined with the commitment to large-scale supply, at low cost, should have a significant impact now, and in the long term, on the lives of those in malaria endemic areas."

P3 data • CNS Disorders • Epilepsy • Infectious Disease • Malaria

Active safety surveillance of rabies monoclonal antibody and rabies vaccine in patients with category III potential rabies exposure. (PubMed, Lancet Reg Health Southeast Asia) - "A vero cell-based inactivated Rabies Vaccine (Rabivax-S) and Rabies Human Monoclonal Antibody (Rabishield) have been approved since 2016. No participant developed rabies during 31 day follow up. The PMS was funded by Serum institute of India Private Limited which is the manufacturer of the study products."

Journal • Musculoskeletal Diseases • Orthopedics

Non-specific Effects of Rabies Vaccine (clinicaltrials.gov) - P4; N=546; Completed; Sponsor: Ross University School of Veterinary Medicine; Enrolling by invitation ➔ Completed

Trial completion • Infectious Disease • Respiratory Diseases

Development of a new purified vero cell rabies vaccine (Rabivax-S) at the serum institute of India Pvt Ltd. (PubMed) - "Following all the GMP requirements the vaccine was tested in GLP toxicology studies. Further it underwent clinical trials in preexposure and postexposure settings and was found safe and immunogenic."

Journal • Biosimilar