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A 9th year follow up study on persitance of Hepatitis A vaccine

Multicentric Study on Persistence of Immune Responses of anti-HAV in Children vaccinated with live attenuated Hepatitis A vaccine Biovac-A TM Upto 9 years

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2017/02/007837
Enrollment
150
Registered
2017-02-13
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

None listed

Interventions

None listed

Sponsors

Wockhardt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects who were enrolled for the Multi-centric Trial on Immunogenecity of single dose of Biovac-ATM Live Attenuated Hepatitis-A Vaccine (MC/Vaccine/2006/CT-01) in 2007 would be considered 2. Subjects who had a baseline anti-HAV antibody titre 3. Written informed consent from the parent or guardian of the subjects.

Exclusion criteria

Exclusion criteria: 1. Subjects who had a baseline anti-HAV antibody titre >20mIU/mL(i.e these subjects are considered to be seroprotected prior to vaccination)

Design outcomes

Primary

MeasureTime frame
1.Primary: To evaluate the long term persistence (upto 9 year) of the anti HAV antibody in subjects, who had been vaccinated with single dose of Biovac A. Timepoint: This post marketing study study will be conducted for 9th year follow up. 1 year annual follow up.—

Secondary

MeasureTime frame
2.Secondary: To document past history of clinical jaundice since vaccination.Timepoint: 1 year annual follow up—

Countries

India

Contacts

Public ContactDr Monjori Mitra

Medclin Research Pvt. Ltd.

monjorimr@gmail.com9831075734

Outcome results

None listed

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