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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02712359
Recruitment Status : Completed
First Posted : March 18, 2016
Results First Posted : September 23, 2019
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE March 7, 2016
First Posted Date  ICMJE March 18, 2016
Results First Submitted Date  ICMJE August 21, 2019
Results First Posted Date  ICMJE September 23, 2019
Last Update Posted Date November 19, 2019
Actual Study Start Date  ICMJE June 1, 2016
Actual Primary Completion Date August 22, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2019)
  • 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).
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 14, 2016)
  • Anti-HAV seropositivity status after administration with the last received dose of Havrix [ Time Frame: At Year 8 visit ]
    Subjects are defined as being seropositive if their anti-HAV antibody concentration is ≥ 15 milli-international unit (mIU)/mL.
  • Anti-HAV seropositivity status after administration with the last received dose of Havrix [ Time Frame: At Year 10 visit ]
    Subjects are defined as being seropositive if their anti-HAV antibody concentration is ≥ 15 milli-international unit (mIU)/mL.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2016)
  • Anti-HAV concentrations (GMC) after administration with the last received dose of Havrix [ Time Frame: At Year 8 and Year 10 visits ]
  • Anti-HAV seropositivity status after administration with the last received dose of Havrix [ Time Frame: At Year 8 and Year 10 visits ]
    Subjects are defined as being seropositive if their anti-HAV antibody concentration is ≥ 15 mIU/mL.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE Long Term Hepatitis A Virus (HAV) Antibody Persistence in Children Vaccinated With 1 Dose and Those Vaccinated With 2 Doses of Havrix in Panama
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Hepatitis A Vaccine
Intervention  ICMJE Other: Blood sample collection
A blood sample (~5mL) will be collected from all subjects at each cross-sectional survey (Year 8 and Year 10).
Study Arms  ICMJE
  • Havrix 1 dose_Year 8 Group
    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.
    Intervention: Other: Blood sample collection
  • Havrix 2 doses_Year 8 Group
    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.
    Intervention: Other: Blood sample collection
  • Havrix 1 dose_Year 10 Group
    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.
    Intervention: Other: Blood sample collection
  • Havrix 2 doses_Year 10 Group
    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.
    Intervention: Other: Blood sample collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 21, 2019)
1201
Original Estimated Enrollment  ICMJE
 (submitted: March 14, 2016)
600
Actual Study Completion Date  ICMJE August 22, 2018
Actual Primary Completion Date August 22, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Panama
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02712359
Other Study ID Numbers  ICMJE 201630
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months
URL: http://clinicalstudydatarequest.com
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP