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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

NCT ID: NCT02712359

Last Updated: 2019-11-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-01

Study Completion Date

2018-08-22

Brief Summary

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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).

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Detailed Description

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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

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Hepatitis A Vaccine

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Havrix 1 dose_Year 8 Group

Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 7 years and less than (\<) 10 years between the administration of the vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.

Group Type OTHER

Blood sample collection

Intervention Type OTHER

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

Havrix 2 doses_Year 8 Group

Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 7 years and less than (\<) 10 years between the administration of the last vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.

Group Type OTHER

Blood sample collection

Intervention Type OTHER

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

Havrix 1 dose_Year 10 Group

Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 10 years and less than (\<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey.

Group Type OTHER

Blood sample collection

Intervention Type OTHER

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

Havrix 2 doses_Year 10 Group

Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 10 years and less than (\<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey.

Group Type OTHER

Blood sample collection

Intervention Type OTHER

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

Interventions

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Blood sample collection

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subjects whose parent(s)/ LAR(s), in the opinion of the investigator, can and will comply with the requirements of the protocol.
* Written informed assent/consent obtained from the subject or subject's parent(s)/ LAR(s) of the subject.
* Available HAV vaccination records.
* Children who have received either 1 or two doses of Havrix at selected health centres of Panama.
* Children with ≥ 7 years and \< 10 years between last dose and Persistence Visit 1 (Year 8) and children ≥ 10 years and \< 13 years between last dose and Persistence Visit 1' (Year 10).

Exclusion Criteria

* Child in care.
* Subjects with history of vaccination with other hepatitis A vaccines other than Havrix.
* Subjects with known past history of hepatitis A infection, both without vaccination and after they received the last dose of Havrix (1 dose or the complete 2 dose schedule).
Minimum Eligible Age

8 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Chiriquí, , Panama

Site Status

GSK Investigational Site

Juán Diaz, , Panama

Site Status

GSK Investigational Site

Panama City, , Panama

Site Status

Countries

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Panama

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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201630

Identifier Type: -

Identifier Source: org_study_id

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