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

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).

Study Overview

• Status: Completed
• Conditions: Hepatitis A Vaccine
• Intervention / Treatment: Other: Blood sample collection

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 Type: Interventional
• Enrollment (Actual): 1201
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Panama
  • Chiriquí, Panama
    • GSK Investigational Site
  • Juán Diaz, Panama
    • GSK Investigational Site
  • Panama, Panama
    • GSK Investigational Site
  • Panamá, Panama
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 15 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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.	Other: Blood sample collection; A blood sample (~5mL) will be collected from all subjects at each cross-sectional survey (Year 8 and Year 10).
OTHER: 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.	Other: Blood sample collection; A blood sample (~5mL) will be collected from all subjects at each cross-sectional survey (Year 8 and Year 10).
OTHER: 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.	Other: Blood sample collection; A blood sample (~5mL) will be collected from all subjects at each cross-sectional survey (Year 8 and Year 10).
OTHER: 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.	Other: Blood sample collection; A blood sample (~5mL) will be collected from all subjects at each cross-sectional survey (Year 8 and Year 10).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-HAV Antibody Concentrations at Approximately 8 Years Following Last Administered Havrix 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.	At approximately 8 years after the last administered vaccine dose
Anti-HAV Antibody Concentrations at Approximately 10 Years Following Last Administered Havrix 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.	At approximately 10 years after the last administered vaccine dose
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	Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 mIU/mL.	At approximately 8 years after the last administered vaccine dose
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	Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 mIU/mL.	At approximately 10 years after the last administered vaccine dose

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2016
• Primary Completion (ACTUAL): August 22, 2018
• Study Completion (ACTUAL): August 22, 2018

Study Registration Dates

• First Submitted: March 7, 2016
• First Submitted That Met QC Criteria: March 14, 2016
• First Posted (ESTIMATE): March 18, 2016

Study Record Updates

• Last Update Posted (ACTUAL): November 19, 2019
• Last Update Submitted That Met QC Criteria: November 5, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Hepatitis; Havrix; Cross-sectional seroprevalence survey; Panama; Long-term persistence
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Liver Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A
• Other Study ID Numbers: 201630

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD for this study will be made available via the Clinical Study Data Request site
• IPD Sharing Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR