A clinical study to assess protection against Chickenpox and also to assess the safety and immunogenicity of Varicella vaccine (BARYCELA) in healthy children between age group 12 months and 12 years in India.

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 - NIL

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/098806

Enrollment

600

Registered

2025-12-10

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: BARYCELA: Powder and solvent for injection to be given subcutaneously. Dose: Single dose of 0.5 ml for 1 Day only. Control Intervention1: VARIPEDÂ®: Powder and solvent for injection to

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy participants of either sex aged 12 months to 12 years. 2. Be in good health based on medical history and as per Investigator judgment. 3. Informed consent,assent of the participant , parents, LAR and their willingness to be followed up for entire study period. 4. Parents, LAR with adequate literacy to fill the participant diary cards. Age of participant should be 12 completed months

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Immunogenicity Proportion of participants who achieve seroconversion at Day 42 after vaccination. Seroconversion: The appearance of antibody titer of 1:4 or higher from seronegative status will be considered as seroconversion at Day 42 after vaccine administration. Timepoint: Immunogenicity Proportion of participants who achieve seroconversion at Day 42 after vaccination. Seroconversion: The appearance of antibody titer of 1:4 or higher from seronegative status will be considered as seroconversion at Day 42 after vaccine administration.	—

Measure

Time frame

Immunogenicity Proportion of participants who achieve seroconversion at Day 42 after vaccination. Seroconversion: The appearance of antibody titer of 1:4 or higher from seronegative status will be considered as seroconversion at Day 42 after vaccine administration. Timepoint: Immunogenicity Proportion of participants who achieve seroconversion at Day 42 after vaccination. Seroconversion: The appearance of antibody titer of 1:4 or higher from seronegative status will be considered as seroconversion at Day 42 after vaccine administration.

—

Secondary

Measure	Time frame
Immunogenicity: â?¢ Geometric mean titer (GMT) at Day 1 (pre-vaccination) and Day 42 postvaccination â?¢ 4- Fold Seroconversion (antibody rise) rate at Day 42 post vaccination in test and reference arm â?¢ Geometric mean fold rise (GMFR) from Day 1 (pre-vaccination) to Day 42 (post vaccination) in test and reference arm Timepoint: Day 42 after vaccination.	—

Countries

India

Contacts

Public Contactneeraj.prasad@jssresearch.com

JSS Medical Research Asia pacific Private Limit

Sonika.newar@jssresearch.com08800799887

Outcome results