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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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ClinicalTrials.gov Identifier: NCT02712359
Recruitment Status : Completed
First Posted : March 18, 2016
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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).

Condition or disease Intervention/treatment Phase
Hepatitis A Vaccine Other: Blood sample collection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : August 22, 2018
Actual Study Completion Date : August 22, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Havrix_dose Group
Subjects with approximately 8 years and 10 years post vaccination with the last received vaccine dose of the complete series (2 doses) and the partial series (1 dose) of Havrix. Thus, the study has two population: one with the complete series of Havrix (2 doses) and the partial series completion (1 dose).
Other: Blood sample collection
A blood sample (~5mL) will be collected from all subjects at each cross-sectional survey (Year 8 and Year 10).




Primary Outcome Measures :
  1. Anti-HAV seropositivity status after administration with the last received dose of Havrix [ Time Frame: At approximately Year 8 and Year 10 visits ]
    Subjects are defined as being seropositive if their anti-HAV antibody concentration is ≥ 15 mIU/mL.


Secondary Outcome Measures :
  1. Anti-HAV concentrations after administration with the last received dose of Havrix [ Time Frame: At approximately Year 8 and Year 10 visits ]
    Geometric Mean Concentrations (GMCs) of anti-HAV concentrations will be assessed.

  2. Anti-HAV seropositivity status after administration with the last received dose of Havrix [ Time Frame: At approximately Year 8 and Year 10 visits ]
    Subjects are defined as being seropositive if their anti-HAV antibody concentration is ≥ 15 mIU/mL.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02712359


Locations
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Panama
GSK Investigational Site
Chiriquí, Panama
GSK Investigational Site
Juán Diaz, Panama
GSK Investigational Site
Panama, Panama
GSK Investigational Site
Panamá, Panama
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02712359     History of Changes
Other Study ID Numbers: 201630
First Posted: March 18, 2016    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018

Keywords provided by GlaxoSmithKline:
Havrix
Cross-sectional seroprevalence survey
Panama
Long-term persistence
Hepatitis

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Antibodies
Hepatitis A Antibodies
Immunologic Factors
Physiological Effects of Drugs