NCT02712359

This Study Will Evaluate the Persistence of Hepatitis A Antibodies, 8 Years and 10 Years Later, in Children Who Had Received Havrix at Selected Health Centres of Panama

Long Term Hepatitis A Virus (HAV) Antibody Persistence in Children Vaccinated With 1 Dose and Those Vaccinated With 2 Doses of Havrix in Panama

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,201 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 8 Years – 15 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the persistence of hepatitis A antibodies, approximately 8 years and 10 years post vaccination with the complete series of Havrix (2 doses) and the partial series completion (1 dose).

Detailed description

The study comprises of two independent cross-sectional surveys (Year 8 and Year 10). The first cross-sectional serosurvey will evaluate the long term persistence of immunity approximately 8 years post vaccine administration and the second cross-sectional study will evaluate long term persistence, approximately 10 years post vaccine administration.

Conditions

• Hepatitis A Vaccine

Interventions

Type	Name	Description
OTHER	Blood sample collection	A blood sample (\~5mL) will be collected from all subjects at each cross-sectional survey (Year 8 and Year 10).

Timeline

• Start date: 2016-06-01
• Primary completion: 2018-08-22
• Completion: 2018-08-22
• First posted: 2016-03-18
• Last updated: 2019-11-19
• Results posted: 2019-09-23

Locations

3 sites across 1 country: Panama