CDSCO Panel advises Dr Reddy's Laboratories to Revise Phase III CT Protocol for Live Attenuated Varicella Vaccine study
New Delhi: Reviewing the Phase III clinical trial protocol presented by the drug major, Dr Reddy's Laboratories, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined the firm to revise the protocol for varicella vaccine (BARYCELA) by including a safety cohort of a total of 100 subjects in the higher age group of the 12 months to 12 years age group with a test and control arm and completing a complete safety study with DSMB (Data and Safety Monitoring Board) review before initiation of the immunogenicity and safety study in the targeted age group.
In addition to the above, the expert panel suggested increasing the number of subjects and including more clinical trial sites representing all geographical regions, including the eastern part of India.
This came after Dr. Reddy's Laboratories presented the Phase III clinical trial protocol titled “A Phase III, Multicentre, Randomized, Observer-blind, Active-controlled, Parallel Group, Non-Inferiority Study to Evaluate Immunogenicity and Safety of Varicella Vaccine (BARYCELA) in Healthy Pediatric Population 12 Months to 12 Years of Age” along with non-clinical and clinical studies conducted in Korea and Thailand.
Chickenpox, or varicella, is a contagious disease caused by the varicella-zoster virus (VZV). The virus is responsible for chickenpox (usually the primary infection in non-immune hosts) and herpes zoster or shingles (following reactivation of latent infection). The Live Attenuated Varicella Vaccine is indicated for the prevention of varicella in children aged 12 months to 12 years of age.
BARYCELA inj., Live Attenuated Varicella Vaccine, is a white lyophilized formulation for injection contained in a colorless and transparent vial that appears as a colorless or light-yellow liquid when dissolved with the enclosed solvent, sterile Water For Injection (WFI).
The vaccine is administered subcutaneously, and it is presented in a 2 mL glass vial of Borosilicate, EP Type Ⅰ clear glass, with a pharmaceutical grade rubber stopper made out of butyl rubber and a cap made of aluminium-plastic combinations.
At the recent SEC meeting for vaccine held on May 31, 2024, the expert panel reviewed the Phase III clinical trial protocol titled “A Phase III, multicentre, randomized, observer-blind, active-controlled, parallel group, non-inferiority study to evaluate immunogenicity and safety of Varicella vaccine (BARYCELA) in a healthy pediatric population 12 months to 12 years of age” along with non-clinical and clinical studies conducted in Korea and Thailand.
After detailed deliberation, the committee suggested modifying the protocol and made the following statements:
1) to include safety cohort of total 100 subjects in a higher age group of the 12 months to 12 years age group with test and control arm and complete safety study with DSMB review before initiation of the immunogenicity and safety study in the targeted age group.2) to increase the number of subjects3) to include more clinical trial sites representing all geographical regions including the eastern part of India.
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