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

Hepatitis A Vaccine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02712359
• Other study ID #: 201630
• Status: Completed
• Phase: N/A
• Start date: June 1, 2016
• Est. completion date: August 22, 2018

Study information

• Verified date: November 2019
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1201
• Est. completion date: August 22, 2018
• Est. primary completion date: August 22, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 15 Years

Eligibility

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).

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis A Vaccine

Intervention

Other:
• Blood sample collection
A blood sample (~5mL) will be collected from all subjects at each cross-sectional survey (Year 8 and Year 10).

Locations

Country	Name	City	State
Panama	GSK Investigational Site	Chiriquí
Panama	GSK Investigational Site	Juán Diaz
Panama	GSK Investigational Site	Panama
Panama	GSK Investigational Site	Panamá

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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