A study to evaluate the efficacy and safety of varicella vaccine in healthy pediatric population.

A Prospective, Randomized, Single Blind, Parallel, Active Controlled, Multicentre, Non-Inferiority Phase III Study to Evaluate The Immunogenicity And Safety Of Live Attenuated Varicella Vaccine Of Sinovac Biotech Ltd, China Compared To VARIPED® Vaccine (Varicella Vaccine Live I.P By MSD Pharmaceuticals Pvt Ltd, India) In Healthy Paediatric Subjects In India - NA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/068581

Enrollment

344

Registered

2024-06-07

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

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

Conditions

None listed

Interventions

Intervention1: Varicella Vaccine: Varicella vaccine (Live Attenuated, Freeze-dried, IP) of M/s Sinovac. A single dose (0.5mL) of test vaccine will be administered to the subject on Day 0 as a subcutan

Eligibility

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1)Subjects with a history of anaphylaxis or serious reactions to other vaccines, 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. #Close contact (family member or neighbor) with a diagnosed case of varicella infection.

Design outcomes

Primary

Measure	Time frame
Immunogenicity: Geometric mean titre of IgG antibodies to Varicella Zoster virus in the two groups at the end of the study Safety, Tolerability: Alone & in comparison. Number & severity of solicited local & systemic adverse events during the first 7 days post vaccination Number, severity and relatedness of all unsolicited AEs through study period post vaccination Number, severity and relatedness of serious adverse events (SAEs) Timepoint: 42 days	—

Measure

Time frame

Immunogenicity: Geometric mean titre of IgG antibodies to Varicella Zoster virus in the two groups at the end of the study Safety, Tolerability: Alone & in comparison. Number & severity of solicited local & systemic adverse events during the first 7 days post vaccination Number, severity and relatedness of all unsolicited AEs through study period post vaccination Number, severity and relatedness of serious adverse events (SAEs) Timepoint: 42 days

—

Secondary

Measure	Time frame
Immunogenicity: Sero-conversion rate at the end of the study for Varicella in the two groups 4- Fold Seroconversion rate for the subjects who are seropositive at baselineTimepoint: 42 days	—

Countries

India

Contacts

Public ContactDr Nidhi Singh

Clinical Research Network India

nidhisingh@crnindia.org9695237796

Outcome results