NCT02712359

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,201

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 18, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 23, 2019

Completed
Last Updated

November 19, 2019

Status Verified

November 1, 2019

Enrollment Period

2.2 years

First QC Date

March 7, 2016

Results QC Date

August 21, 2019

Last Update Submit

November 5, 2019

Conditions

Hepatitis A Vaccine

Keywords

HavrixCross-sectional seroprevalence surveyPanamaLong-term persistenceHepatitis

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • 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 at Approximately 10 Years Following Last Administered Havrix Dose

    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

    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

    At approximately 10 years after the last administered vaccine dose

Study Arms (4)

Havrix 1 dose_Year 8 Group

OTHER

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

Havrix 2 doses_Year 8 Group

OTHER

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

Havrix 1 dose_Year 10 Group

OTHER

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

Havrix 2 doses_Year 10 Group

OTHER

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

Interventions

Blood sample collectionOTHER

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 GroupHavrix 1 dose_Year 8 GroupHavrix 2 doses_Year 10 GroupHavrix 2 doses_Year 8 Group

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

GSK Investigational Site

Chiriquí, Panama

Location

GSK Investigational Site

Juán Diaz, Panama

Location

GSK Investigational Site

Panama City, Panama

Location

MeSH Terms

Conditions

Hepatitis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
GSKClinicalSupportHD@gsk.com
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2016

First Posted

March 18, 2016

Study Start

June 1, 2016

Primary Completion

August 22, 2018

Study Completion

August 22, 2018

Last Updated

November 19, 2019

Results First Posted

September 23, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will share

IPD for this study will be made available via the Clinical Study Data Request site

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
IPD will be made available within 6 months of publishing the results of the primary endpoints of the study
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
More information

Locations

PA(3)