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A 20 year follow up study of a Single Dose of Live Attenuated Hepatitis A Vaccine

Persistence of Immunogenicity of a Single Dose of Live Attenuated Hepatitis A Vaccine: A Follow-up Study 20 Years After Vaccination - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/02/081285
Enrollment
109
Registered
2025-02-25
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: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Dr. Reddys Laboratories Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Received a single dose of the Hepatitis A vaccine in 2004 2. Assessed at any of the follow-up studies 3. Willingness to provide written informed consent for the current study

Exclusion criteria

Exclusion criteria: 1. Refusal or inability to comply with the requirements of the protocol for any reason 2. Any other condition or concomitant medication that would make the patient, in the opinion of the Investigator, unsuitable for the study

Design outcomes

Primary

MeasureTime frame
1.To evaluate the seroprotection rate of a single dose of live attenuated hepatitis A vaccine- 20 years after vaccination amongst the subjects 2. To evaluate the GMT of total anti-HAV antibodyTimepoint: Single visit (Baseline)—

Secondary

MeasureTime frame
1. To evaluate the proportion of subjects who are anti-HAV IgM antibody-positive 2. To evaluate the occurrence of clinical hepatitis-like illness during 20 years post vaccination with a single dose of live attenuated hepatitis A vaccineTimepoint: Single visit (Baseline)—

Countries

India

Contacts

Public ContactDr Sagar Katare

Dr. Reddys Laboratories Ltd

abhishek.t@drreddys.com7675817463

Outcome results

None listed

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