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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Recruitment Status : Withdrawn (This study has been cancelled before initiation due to company's prioritisation decisions linked to resources restrictions.)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

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.

Condition or disease Intervention/treatment Phase
Hepatitis B Hepatitis A Procedure: Blood sampling Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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)
Study Start Date : May 2015
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).
Procedure: Blood sampling
At Years 16 - 20 after first dose of the primary vaccination in HAB-084 (208127/084) study.

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).
Procedure: Blood sampling
At Years 16 - 20 after first dose of the primary vaccination in HAB-084 (208127/084) study.




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. Occurrence of Serious adverse events (SAEs) [ Time Frame: During the entire study period (Year 16-20) ]


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT02135666


Locations
Czech Republic
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 01
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02135666     History of Changes
Other Study ID Numbers: 117307
2013-004586-13 ( EudraCT Number )
First Posted: May 12, 2014    Key Record Dates
Last Update Posted: November 18, 2015
Last Verified: November 2015

Keywords provided by GlaxoSmithKline:
Twinrix
Long-term follow-up
Persistence
Hepatitis A
Antibody
Immunity
Hepatitis B
Combination vaccine
Adult

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