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Evaluation of the Long-term Hepatitis A and B Antibody Persistence in Healthy Adult Subjects, Primed 16 to 20 Years Earlier With GSK Biologicals' Combined Hepatitis A and B Vaccine, Twinrix® (SB208127) in Study HAB-084 (208127/084)

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ClinicalTrials.gov Identifier: NCT02135666
Recruitment Status : Withdrawn (This study has been cancelled before initiation due to company's prioritisation decisions linked to resources restrictions.)
First Posted : May 12, 2014
Last Update Posted : November 18, 2015
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE May 8, 2014
First Posted Date  ICMJE May 12, 2014
Last Update Posted Date November 18, 2015
Study Start Date  ICMJE May 2015
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2014)
Immunogenicity with respect to components of the study vaccine in terms of antibody titres [ Time Frame: At each long-term follow-up (LTFU) visit (16-20 years after the first dose of primary vaccination) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2014)
Occurrence of Serious adverse events (SAEs) [ Time Frame: During the entire study period (Year 16-20) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Long-term Hepatitis A and B Antibody Persistence in Healthy Adult Subjects, Primed 16 to 20 Years Earlier With GSK Biologicals' Combined Hepatitis A and B Vaccine, Twinrix® (SB208127) in Study HAB-084 (208127/084)
Official Title  ICMJE Long-term Hepatitis A and B Antibody Persistence in Healthy Adult Subjects, Primed 16 to 20 Years Earlier With GSK Biologicals' Combined Hepatitis A and B Vaccine, Twinrix® (SB208127) in Study HAB-084 (208127/084)
Brief Summary The purpose of this study is to assess the long-term persistence of immunity to hepatitis A and B in adults who were vaccinated 16-20 years earlier with the combined hepatitis A and hepatitis B vaccine, Twinrix.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Hepatitis B
  • Hepatitis A
Intervention  ICMJE Procedure: Blood sampling
At Years 16 - 20 after first dose of the primary vaccination in HAB-084 (208127/084) study.
Study Arms  ICMJE
  • Experimental: 2-dose Primed Group
    Adolescent subjects in this group received 2 doses of Twinrix Adult (720/20) (licensed as Ambirix in the EU) according to a 0, 6 months schedule in the primary study HAB-084 (208127/084).
    Intervention: Procedure: Blood sampling
  • Experimental: 3-dose Primed Group
    Adolescent subjects in this group received 3 doses of Twinrix Junior (360/10) according to a 0, 1, 6 months schedule in the primary study HAB-084 (208127/084).
    Intervention: Procedure: Blood sampling
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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 16, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: May 8, 2014)
180
Estimated Study Completion Date  ICMJE October 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • A male or female who received two/three doses of Twinrix according to his/her group allocation in study HAB-084 (208127/084), and received no further dose of any hepatitis A and/or B vaccine since then.
  • Written informed consent obtained from the subject.

Exclusion Criteria:

  • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to study entry. Inhaled and topical steroids are allowed.
  • Administration of long-acting immune-modifying drugs within six months prior to the study entry.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
  • Administration of any hepatitis A and/or B vaccine at any time since completion of the primary vaccination series in HAB-084 (208127/084) study, including a challenge dose of the study vaccine, as a part of the study procedures, during the long-term persistence phase.
  • Documented history of hepatitis A or B disease since completion of the primary vaccination series in HAB-084 (208127/084) study.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • Administration of immunoglobulins within six months prior to study entry.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02135666
Other Study ID Numbers  ICMJE 117307
2013-004586-13 ( EudraCT Number )
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 November 2015

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