Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 66 of 278 for:    Panama

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
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE March 7, 2016
First Posted Date  ICMJE March 18, 2016
Last Update Posted Date September 10, 2018
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: October 4, 2016)
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.
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 Complete list of historical versions of study NCT02712359 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2018)
  • 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.
  • 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.
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 Intervention Model: Single Group 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_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).
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: May 8, 2018)
1200
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 Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date September 2018

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