Revise Phase I/II CT protocol: CDSCO panel tells Serum Institute of India on Dengue Tetravalent Vaccine
New Delhi: Regarding the Phase I/II clinical trial of Dengue Tetravalent Vaccine (Live, Attenuated), the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has opined the vaccine major Serum Institute of India to revise the Phase I/II clinical trial protocol.
This came after the firm presented its proposal to conduct of Phase I/II clinical trial of the Dengue Tetravalent Vaccine (Live, Attenuated).
Dengue Tetravalent Vaccine (Live, Attenuated) provides protection against fever and hospitalization resulting from dengue disease caused by any of the 4 dengue virus serotypes. Side effects are mostly mild to moderate in severity and disappear within a few days.
Dengue disease is a mosquito-borne tropical disease caused by the dengue virus, leading to mild, flu-like symptoms in most people. However, a small number of patients develop severe disease, with potentially fatal bleeding and organ damage.
This vaccine contains attenuated (weakened) versions of dengue virus serotypes (varieties) 1, 2, 3 and 4.
At the recent SEC meeting for Vaccine held on 23rd March 2023, the expert panel reviewed the proposal presented by vaccine major Serum Institute of India to conduct Phase I/II clinical trial of Dengue Tetravalent Vaccine (Live, Attenuated).
After detailed deliberation, the committee recommended that the firm should revise the Phase I/II clinical trial protocol as below:
1. The trial design should be seamless with Phase I followed by Phase II along with DSMB review after Phase-I. The clinical trial report of Phase-I with DSMB recommendations should be submitted before the initiation of Phase II.
2. The clinical trial should be stratified and conducted in adult subjects initially and then in pediatric subjects.
3. The inclusion of seropositive and seronegative subjects should be clearly defined in the protocol.
Accordingly, the expert panel suggested that the firm should submit revised clinical trial protocol for further deliberation.
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