Revise Phase II/III CT protocol of Yellow Fever Vaccine Live: CDSCO Panel Tells Serum Institute of India

Written by Dr. Divya Colin Published On 2023-03-04T18:00:51+05:30 | Updated On 14 Feb 2024 12:33 AM IST

Revise Phase II/III CT protocol of Yellow Fever Vaccine Live: CDSCO Panel Tells Serum Institute of India

New Delhi: Reviewing the proposal presented by the vaccine maker Serum Institute of India to conduct Phase II/III clinical trial of Yellow Fever Vaccine, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to revise the Phase II/III clinical trial protocol.

This came after firm presented its proposal for grant of permission to conduct Phase II/III clinical trial of Yellow Fever Vaccine (Live) (I.P.) in ≥ 9 months to <18 years of age group along with Phase I clinical trial report.

Yellow fever is an acute viral haemorrhagic disease transmitted by infected mosquitoes. The "yellow" in the name refers to the jaundice that affects some patients. Symptoms of yellow fever include fever, headache, jaundice, muscle pain, nausea, vomiting and fatigue. A small proportion of patients who contract the virus develop severe symptoms and approximately half of those die within 7 to 10 days.

Yellow Fever Vaccine (Live) is a live-attenuated vaccine. This means that the vaccine uses a weakened, or attenuated, form of the yellow fever virus. As this type of vaccine is so similar to the natural infection, the body can create a strong and long-lasting immune response from just one dose without the need for a booster shot.

At the recent SEC meeting for Vaccines, the expert panel reviewed the Phase-I clinical trial report and recommended that the firm should submit detailed data on protocol deviations which should include:

1) No of subjects visited in each study visit in compliance with protocol.

2) Immunization data on Day 28

3) Details of visits and safety follow-up for each subject.

4) Details of each deviation and its evaluation with justification.

Furthermore, in response to the Phase II/III clinical trial protocol presented by the vaccine maker Serum Institute of India, the committee after detailed deliberation recommended that the firm should revise the Phase II/III clinical trial protocol as below:

1) Phase II and Phase III design should be separated in the protocol with a clear objectives & distribution of subjects in both phases.

2) The safety (solicited adverse events reported) should be assessed for all the subjects enrolled in the clinical trial with diary cards.

3) The number of subjects should be increased with a statistically significant sample size.

4) The clinical trial should be stratified and required to be conducted in adult subjects followed by a trial in a pediatric population specifying age group cohorts.

Also Read: Submit justification: CDSCO panel tells Hetero for FDC Lacosamide, Brivaracetam

Serum Institute of IndiaYellow Fever Vaccinecdscovaccineclinical trail

Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.