Zydus Lifscience gets CDSCO Panel nod to study Rabies Vaccine

New Delhi: Zydus Lifscience has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase IV clinical trial Rabies Vaccine, Human I.P. (Purified Chick Embryo Cell Culture Rabies Vaccine) (PCECVPM).

This came after the firm presented the Phase IV clinical trial protocol titled, "A prospective, randomized, single-blind, parallel, active-controlled, multicentre Phase IV clinical study to evaluate the long-term immunogenicity and safety of VaxiRab N compared to a WHO-prequalified rabies vaccine in animal bite cases."

Rabies Vaccine, Human I.P. (Purified Chick Embryo Cell Culture Vaccine (PCECV)) is a vaccine that protects people from rabies by exposing them to a small amount of the virus.

Rabies purified chick embryo cell vaccine is used to protect people who have been bitten by animals (post-exposure) or otherwise may be exposed to the rabies virus (pre-exposure). This vaccine works by exposing the body to a small dose of the virus, which causes the body to develop immunity to the disease.

At the recent SEC meeting for vaccine held on November 26, 2024, the expert panel reviewed the Phase IV clinical trial protocol titled, "A prospective, randomized, single- blind, parallel, active-controlled, multicentre, Phase IV clinical study to evaluate the long-term immunogenicity and safety of VaxiRab N compared to a WHO prequalified rabies vaccine.n animal bite cases."

After detailed deliberation, the committee recommended the conduct of the Phase IV clinical trial as per the presented protocol.

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