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

This will be a 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.

The study will enroll approximately 600 healthy pediatric participants to receive single dose of either test product Varicella vaccine (live attenuated) of Dr. Reddy’s Laboratories Limited or reference VARIPED® Vaccine (Varicella Vaccine Live I.P By MSD Pharmaceuticals Pvt Ltd, India) in 1:1 ratio. Participants aged 12 months to 12 years who give their assent as applicable to participate in the study and whose parents/legally authorized representatives (LARs) are willing to give informed consent will be included in the study.

Prospective participants will be screened and assessed for safety and eligibility to participate in the study, including assessment of medical history, vital signs and physical examination (PE) will be randomized and receive the vaccination (visit 1). Participants would be observed for at least 30 minutes at study site for any adverse events. Thereafter, enrolled participants would be followed up telephonically on visits scheduled on: day 7 (± 3) (visit 2) and day 21 (± 3) (visit 3). Subsequently, physical onsite visit will be conducted on day 42 (+7) which will be end of study visit.

All study participants will receive 1 single dose of either test or reference vaccine as per their randomization arm on Visit 1 (Day 1).