Clinical study to compare the immune response and safety of Chicken Pox vaccine manufactured by Cadila Healthcare Ltd. with another Chicken Pox vaccine marketed in India in children 1-12 years of age

A prospective, randomized, single blind, parallel, active controlled, multicentre, non-inferiority clinical study to evaluate the immunogenicity and safety of Varicella vaccine (Live Attenuated, Freeze Dried IP) of M/s Cadila Healthcare Limited compared to a marketed Varicella vaccine in healthy paediatric subjects aged 1 to 12 years

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/07/006059

Enrollment

256

Registered

2015-07-31

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: Z23- Encounter for immunization

Interventions

Intervention1: Varicella vaccine (Live Attenuated, Freeze-dried, IP) of M/s Cadila Healthcare Limited: Each subject will be given a single dose of 0.5ml vaccine given as a subcutaneous injection in th

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy paediatric subjects of either sex aged 1 year to 12 years 2. Informed consent of the parents/guardians and their willingness to be followed up for at least 6 weeks after vaccination of their child 3. Parents/guardians with adequate literacy to fill the diary cards

Exclusion criteria

Exclusion criteria: 1. Subjects with a history of anaphylaxis or serious reactions to other vaccines, neomycin, gelatin and / or albumin 2. Subjects with a history of previous varicella infection or vaccination, or if they had been exposed to the disease within 30 days of trial commencement 3. Subjects with a history of convulsions, seizures, other central nervous system diseases, severe disease of haematopoietic system, cardiovascular system, liver or kidney 4. Subjects with an acute febrile illness at the time of randomization 5. Any other vaccine administration within 30 days of initiation of the study or planned during the study period 6. A history of serious chronic illness, major congenital defects, immunosuppression (immunosuppressive illness or therapy) 7. Subjects who have received blood, blood products or immunoglobulins during the preceding 6 months or have planned during the study period 8. Subjects with any other clinically significant concurrent illness affecting immune response after vaccination

Design outcomes

Primary

Measure	Time frame
Geometric mean titre of IgG antibodies to Varicella Zoster virus in the two groups at the end of the studyTimepoint: 42 days following vaccination	—

Secondary

Measure	Time frame
Sero-conversion rate at the end of the study for Varicella in the two groupsTimepoint: 42 days following vaccination	—

Countries

India

Contacts

Public ContactDr Jayesh Sanmukhani

Cadila Healthcare Ltd

r.mittal@zyduscadila.com079-26868926

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026