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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Hepatitis A Vaccine

Treatments: Other: Blood sample collection

Study type: Interventional

Funder types: Industry

Identifiers

NCT02712359

201630

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,201 patients

Sex: All

Ages: 8 to 15 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,201 participants in 4 patient groups

Havrix 1 dose_Year 8 Group

Other group

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.

Treatment:

Other: Blood sample collection

Havrix 2 doses_Year 8 Group

Other group

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.

Treatment:

Other: Blood sample collection

Havrix 1 dose_Year 10 Group

Other group

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.

Treatment:

Other: Blood sample collection

Havrix 2 doses_Year 10 Group

Other group

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.

Treatment:

Other: Blood sample collection