Back to resultsThis 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
Primary Purpose
Hepatitis A Vaccine
Status
Completed
Phase
Not Applicable
Locations
Panama
Study Type
Interventional
Intervention
Blood sample collection
Sponsored by
About this trial
This is an interventional other trial for Hepatitis A Vaccine focused on measuring Havrix, Cross-sectional seroprevalence survey, Panama, Long-term persistence, Hepatitis
Eligibility Criteria
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).
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
Other
Arm Label
Havrix 1 dose_Year 8 Group
Havrix 2 doses_Year 8 Group
Havrix 1 dose_Year 10 Group
Havrix 2 doses_Year 10 Group
Arm Description
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02712359
Brief Title
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
Official Title
Long Term Hepatitis A Virus (HAV) Antibody Persistence in Children Vaccinated With 1 Dose and Those Vaccinated With 2 Doses of Havrix in Panama
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
August 22, 2018 (Actual)
Study Completion Date
August 22, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis A Vaccine
Keywords
Havrix, Cross-sectional seroprevalence survey, Panama, Long-term persistence, Hepatitis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1201 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Havrix 1 dose_Year 8 Group
Arm Type
Other
Arm Description
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.
Arm Title
Havrix 2 doses_Year 8 Group
Arm Type
Other
Arm Description
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.
Arm Title
Havrix 1 dose_Year 10 Group
Arm Type
Other
Arm Description
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.
Arm Title
Havrix 2 doses_Year 10 Group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Blood sample collection
Intervention Description
A blood sample (~5mL) will be collected from all subjects at each cross-sectional survey (Year 8 and Year 10).
Primary Outcome Measure Information:
Title
Number of Subjects With Anti-hepatitis A Virus (HAV) Seropositivity Status at Approximately 8 Years Following Last Administered Havrix Dose
Description
Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 milli-international unit/milliliter (mIU/mL).
Time Frame
At approximately 8 years after the last administered vaccine dose
Title
Number of Subjects With Anti-HAV Seropositivity Status at Approximately 10 Years Following Last Administered Havrix Dose
Description
Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 mIU/mL.
Time Frame
At approximately 10 years after the last administered vaccine dose
Secondary Outcome Measure Information:
Title
Anti-HAV Antibody Concentrations at Approximately 8 Years Following Last Administered Havrix Dose
Description
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.
Time Frame
At approximately 8 years after the last administered vaccine dose
Title
Anti-HAV Antibody Concentrations at Approximately 10 Years Following Last Administered Havrix Dose
Description
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.
Time Frame
At approximately 10 years after the last administered vaccine dose
Title
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
Description
Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 mIU/mL.
Time Frame
At approximately 8 years after the last administered vaccine dose
Title
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
Description
Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 mIU/mL.
Time Frame
At approximately 10 years after the last administered vaccine dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Chiriquí
Country
Panama
Facility Name
GSK Investigational Site
City
Juán Diaz
Country
Panama
Facility Name
GSK Investigational Site
City
Panama
Country
Panama
Facility Name
GSK Investigational Site
City
Panamá
Country
Panama
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
http://clinicalstudydatarequest.com
Learn more about this trial
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
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