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:
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