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

Phase 3

• Registration Number: CTRI/2024/06/068581
• Lead Sponsor: Techinvention Lifecare Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified