Clinical trial NCT02712359: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis A Vaccine
Keywords: Havrix
Cross-sectional seroprevalence survey
Panama
Long-term persistence
Hepatitis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2016-03-18
Enrollment: 1201
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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).

Primary outcomes:
measure: Number of Subjects With Anti-hepatitis A Virus (HAV) Seropositivity Status at Approximately 8 Years Following Last Administered Havrix Dose
timeFrame: At approximately 8 years after the last administered vaccine dose
measure: Number of Subjects With Anti-HAV Seropositivity Status at Approximately 10 Years Following Last Administered Havrix Dose
timeFrame: At approximately 10 years after the last administered vaccine dose
Secondary outcomes:
measure: Anti-HAV Antibody Concentrations at Approximately 8 Years Following Last Administered Havrix Dose
timeFrame: At approximately 8 years after the last administered vaccine dose
measure: Anti-HAV Antibody Concentrations at Approximately 10 Years Following Last Administered Havrix Dose
timeFrame: At approximately 10 years after the last administered vaccine dose
measure: 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
timeFrame: At approximately 8 years after the last administered vaccine dose
measure: 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
timeFrame: At approximately 10 years after the last administered vaccine dose
Other outcomes:
Locations:
city: Chiriquí
country: Panama
facility: GSK Investigational Site
city: Juán Diaz
country: Panama
facility: GSK Investigational Site
city: Panama
country: Panama
facility: GSK Investigational Site
city: Panamá
country: Panama
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: