Dr Reddy's Laboratories gets CDSCO Panel nod to study Live Attenuated Varicella Vaccine
New Delhi: Dr. Reddy's Laboratories has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct a Phase III clinical trial of the Live Attenuated Varicella Vaccine to evaluate the immunogenicity and safety of the Varicella Vaccine (BARYCELA) in a healthy pediatric population 12 months to 12 years of age.
However, this nod came in line with the condition that the firm should conduct immunogenicity analysis for all proposed 500 evaluable subjects in part 2 of the trial, with age stratification for all proposed age groups.
This took place following the firm's presentation of the revised Phase III clinical trial protocol for the Live Attenuated Varicella Vaccine study 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”.
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.
Earlier, the Medical Dialogues Team had reported that the Subject Expert Committee (SEC) of the Central Drug Standard Control Organization (CDSCO) had opined Dr. Reddy's Laboratories 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 continuation, at the recent SEC meeting for vaccine held on August 22, 2024, the expert panel reviewed the revised Phase III clinical trial protocol of the Live Attenuated Varicella Vaccine study titled “A Phase III, multicentre, randomized, observer-blind, active-controlled, parallel-group, non-inferiority study to evaluate the immunogenicity and safety of Varicella vaccine (BARYCELA) in Healthy Pediatric Population 12 months to 12 years of age”.
After detailed deliberation, the committee recommended the approval of the presented Phase-III clinical trial protocol with the condition of conducting immunogenicity analysis for all proposed 500 evaluable subjects in Part 2 of the trial with age stratification for all proposed age groups.
Accordingly, the expert panel suggested that the revised protocol should be submitted to CDSCO for further approval.
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