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

Not Applicable

Completed

• Conditions: Hepatitis A Vaccine
• Interventions: Other: Blood sample collection

• Registration Number: NCT02712359
• Lead Sponsor: GlaxoSmithKline

Brief 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.

Study Timeline

• Study First Submitted: 2016-03-07
• Study First Submitted QC: 2016-03-14
• Study First Posted: 2016-03-18
• Study Start: 2016-06-01
• Primary Completion: 2018-08-22
• Study Completion: 2018-08-22
• Results First Submitted: 2019-08-21
• Results First Submitted QC: 2019-08-21
• Results First Posted: 2019-09-23
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-05
• Last Update Posted: 2019-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1201

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).

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Havrix 2 doses_Year 10 Group	Blood sample collection	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.
Havrix 1 dose_Year 8 Group	Blood sample collection	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.
Havrix 2 doses_Year 8 Group	Blood sample collection	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.
Havrix 1 dose_Year 10 Group	Blood sample collection	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.

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Anti-hepatitis A Virus (HAV) Seropositivity Status at Approximately 8 Years Following Last Administered Havrix Dose	At approximately 8 years after the last administered vaccine dose	Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 milli-international unit/milliliter (mIU/mL).
Number of Subjects With Anti-HAV Seropositivity Status at Approximately 10 Years Following Last Administered Havrix Dose	At approximately 10 years after the last administered vaccine dose	Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 mIU/mL.

Secondary Outcome Measures

Name	Time	Method
Anti-HAV Antibody Concentrations at Approximately 8 Years Following Last Administered Havrix Dose	At approximately 8 years after the last administered vaccine dose	Anti-HAV antibody concentrations were measured by ELISA, expressed as GMCs, in mIU/mL. The cut-off of the assay was an anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL.
Anti-HAV Antibody Concentrations at Approximately 10 Years Following Last Administered Havrix Dose	At approximately 10 years after the last administered vaccine dose	Anti-HAV antibody concentrations were measured by ELISA, expressed as GMCs, in mIU/mL. The cut-off of the assay was an anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL.
Number of Subjects With Anti-HAV Antibody Concentration ≥ 15 mIU/mL at Approximately 8 Years Following Last Administered Havrix Dose - Exploration of Non-inferiority of the 1-dose Schedule Compared to the 2-dose Schedule of Havrix	At approximately 8 years after the last administered vaccine dose	Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 mIU/mL.
Number of Subjects With Anti-HAV Antibody Concentrations ≥ 15 mIU/mL at Approximately 10 Years Following Last Administered Havrix Dose - Exploration of Non-inferiority of the 1-dose Schedule Compared to the 2-dose Schedule of Havrix	At approximately 10 years after the last administered vaccine dose	Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 mIU/mL.

Trial Locations

Locations (1)

GSK Investigational Site; 🇵🇦 Panamá, Panama