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Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Engerix™-B in Adults With or Without Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01627340
First received: June 21, 2012
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

This study will evaluate the immunogenicity and safety of Engerix™-B (hepatitis B vaccine) when administered as a primary vaccination course at 0, 1 and 6 months in adults with or without type 2 diabetes mellitus.


Condition Intervention Phase
Hepatitis B
Biological: Engerix™-B
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An Open-label Study to Assess the Immunogenicity and Safety of GSK Biologicals' Hepatitis B Vaccine Engerix™-B (103860) in Adults With or Without Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Immunogenicity with respect to components of the study vaccine, in terms of number of seroprotected subjects. [ Time Frame: One month after the third dose of primary vaccination (Month 7). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity with respect to components of the study vaccine in terms of antibody concentrations. [ Time Frame: One month after the third dose of primary vaccination (Month 7). ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general symptoms. [ Time Frame: During the 4-day (Day 0-Day 3) follow-up period after each vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events. [ Time Frame: During the 31-day (Day 0-Day 30) follow-up period after each vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events. [ Time Frame: From Dose 1 (Day 0) up to study end (i.e. Month 7). ] [ Designated as safety issue: No ]

Enrollment: 667
Study Start Date: July 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diabetes Group
Subjects diagnosed with type 2 diabetes within the past five years.
Biological: Engerix™-B
Intramuscular, three doses
Other Name: HBV
Active Comparator: Control Group
Subjects with no diagnosis or documented history of diabetes.
Biological: Engerix™-B
Intramuscular, three doses
Other Name: HBV

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

All subjects must satisfy ALL the following criteria at study entry:

  • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • A male or female subject aged 20 years and above at the time of screening.
  • Written informed consent obtained from the subject at screening.
  • Subjects diagnosed with type 2 diabetes documented within the past five years, according to the criteria specified by the American Diabetes Association or currently taking any form of anti-diabetic intervention documented by the investigator; or control subjects with no diagnosis or documented history of diabetes, and HbA1c less than 6.5%, as determined by laboratory screening tests.
  • Normal renal function defined as estimated glomerular filtration rate (GFR) ≥ 50 mL/min, estimated through the Modification of Diet in Renal Disease (MDRD) or the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, as determined by laboratory screening tests.
  • Seronegative for hepatitis B surface antigen (HBsAg), anti-HBs antibodies and antibodies to hepatitis B core antigen (anti HBc), as determined by laboratory screening tests.
  • Female subjects of non-childbearing potential may be enrolled in the study.

    • Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject:

    • has practiced adequate contraception for 30 days prior to vaccination, and
    • has a negative pregnancy test on the day of screening and at Visit 1, and
    • has agreed to continue adequate contraception during the entire treatment period and for two months after completion of the vaccination series.

Exclusion Criteria:

The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:

  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Administration of long-acting immune-modifying drugs within 6 months of the study entry or planned administration at any time during the study period.
  • Administration of a vaccine not foreseen by the study protocol starting from 30 days before each dose of vaccine and ending 30 days after each dose, with the exception of the inactivated influenza vaccine which is allowed at any time during the study if administered at a separate site.
  • 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 protocol-specified non-investigational product.
  • Any previous complete or incomplete vaccination against hepatitis B since birth.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection, based on medical history and physical examination.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine, including latex.
  • Advanced heart failure or any other severe clinical condition that significantly reduces the subject's life expectancy.
  • Acute disease and/or fever at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
  • Any history of alcohol or drug abuse in the past 5 years.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01627340

  Show 22 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01627340     History of Changes
Other Study ID Numbers: 115918
Study First Received: June 21, 2012
Last Updated: June 26, 2014
Health Authority: New Zealand: Medsafe
United States: Food and Drug Administration
Canada: Biologics and Genetic Therapies Directorate (BGTD)
Australia: Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:
Engerix™-B
hepatitis B
adults
Type 2 diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hepatitis
Hepatitis A
Hepatitis B
DNA Virus Infections
Digestive System Diseases
Endocrine System Diseases
Enterovirus Infections
Glucose Metabolism Disorders
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Metabolic Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014