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OpenTrials
Completed

NCT Number: 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

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).

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Key information

Age range

8 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GSK Investigational Site, Chiriquí, Panama

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Blood Sample Collection

Other

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

Primary outcomes

  1. Number of Subjects With Anti-hepatitis A Virus (HAV) Seropositivity Status at Approximately 8 Years Following Last Administered Havrix Dose

    Time frame: At approximately 8 years after the last administered vaccine 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).

  2. Number of Subjects With Anti-HAV Seropositivity Status at Approximately 10 Years Following Last Administered Havrix Dose

    Time frame: At approximately 10 years after the last administered vaccine dose

    Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 mIU/mL.

Secondary outcomes

  1. Anti-HAV Antibody Concentrations at Approximately 8 Years Following Last Administered Havrix Dose

    Time frame: At approximately 8 years after the last administered vaccine 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.

  2. Anti-HAV Antibody Concentrations at Approximately 10 Years Following Last Administered Havrix Dose

    Time frame: At approximately 10 years after the last administered vaccine 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.

  3. 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

    Time frame: At approximately 8 years after the last administered vaccine dose

    Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 mIU/mL.

  4. 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

    Time frame: At approximately 10 years after the last administered vaccine dose

    Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 mIU/mL.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 18, 2016
Registry last updated
Nov 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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