Revise Phase IV CT Protocol: CDSCO panel tells Zydus Lifesciences on Typhoid Vi Conjugate Vaccine with Yellow Fever Vaccine
New Delhi: In response to the drug major Zydus Life Sciences' proposal to conduct Phase IV clinical for Typhoid Vi Conjugate Vaccine I.P.(TCV) with Yellow Fever Vaccine(YFV), the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has opined the firm to revise the Phase IV clinical trial protocol.
This came after the firm presented its proposal for conducting a Phase IV clinical trial of Typhoid Vi Conjugate Vaccine I.P. (TCV) with Yellow Fever Vaccine (YFV).
TCV Vaccine is an active immunizing agent. It is given to prevent typhoid fever caused by certain bacteria called S. Typhi. It is usually administered at least 2 weeks prior to expected exposure to S. Typhi. Inactivated typhoid vaccine is administered as an injection (shot). It may be given to people 2 years and older. One dose is recommended at least 2 weeks before travel. Repeated doses are recommended every 2 years for people who remain at risk.
Yellow fever vaccine is a vaccine that protects against yellow fever. Yellow fever is a viral infection that occurs in Africa and South America. Most people begin to develop immunity within ten days of vaccination and 99 per cent are protected within one month, and this appears to be lifelong. The vaccine can be used to control outbreaks of disease. It is given either by injection into a muscle or just under the skin.
At the recent SEC meeting for Vaccines held on 23rd of March 2023, the expert panel reviewed the proposal to conduct the Phase IV clinical trial of the Typhoid Vi Conjugate Vaccine I.P. (TCV) with Yellow Fever Vaccine (YFV).
After detailed deliberation, the committee recommended that the firm should revise the Phase IV clinical trial protocol as below:
1. Blood samples should not be withdrawn at visit 2.
2. There should be two reference groups. One group should be administered with the Yellow fever vaccine and other groups should be administered with Typhoid conjugate vaccine.
3. The sample size, primary and secondary endpoints should be defined in accordance with the groups.
Accordingly, the expert panel opined the firm to submit revised clinical trial protocol for further deliberation.
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