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).
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 Blood samples should not be withdrawn at visit 2.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.