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: January 5, 2015
Last verified: December 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 vaccine
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:
  • Number of Subjects Seroprotected for Anti- Hepatitis B Surface Antigen (Anti-HBs) Antibodies [ Time Frame: At one month after the third dose of primary vaccination (Month 7) ] [ Designated as safety issue: No ]
    A seroprotected subject was defined as a vaccinated subject with an anti-HBs antibody concentration greater than or equal to (≥) 10 milli-international units per milliliter (mIU/mL).


Secondary Outcome Measures:
  • Anti-HBs Antibody Concentration [ Time Frame: At one month after the third dose of primary vaccination (Month 7) ] [ Designated as safety issue: No ]
    Concentrations were given as geometric mean concentration (GMC) and expressed as mIU/mL

  • Number of Subjects Reporting Any Solicited Local Symptoms [ Time Frame: During the 4-day (Days 0-3) post-vaccination period ] [ Designated as safety issue: No ]
    Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of the specified solicited local symptom regardless of its intensity grade.

  • Number of Subjects Reporting Any Solicited General Symptoms [ Time Frame: During the 4-day (Days 0-3) post-vaccination period ] [ Designated as safety issue: No ]
    Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Any fever = oral temperature greater than or equal to (≥) 37.5 degrees Celsius (°C)

  • Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day (Days 0-30) post-vaccination period ] [ Designated as safety issue: No ]
    An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.

  • Number of Subjects Reporting Any Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (Month 0 - Month 7) ] [ Designated as safety issue: No ]
    A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.


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 five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
Biological: Engerix™-B vaccine
3 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
Other Name: HBV
Active Comparator: Control Group
Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Biological: Engerix™-B vaccine
3 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
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

  Hide Study Locations
Locations
United States, Alabama
GSK Investigational Site
Huntsville, Alabama, United States, 35802
United States, Georgia
GSK Investigational Site
Stockbridge, Georgia, United States, 30281
United States, Idaho
GSK Investigational Site
Boise, Idaho, United States, 83642
United States, Indiana
GSK Investigational Site
Mishawaka, Indiana, United States, 46545
United States, Kansas
GSK Investigational Site
Wichita, Kansas, United States, 67207
United States, New York
GSK Investigational Site
Endwell, New York, United States, 13760
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44122
United States, Tennessee
GSK Investigational Site
Nashville, Tennessee, United States, 37203
United States, Utah
GSK Investigational Site
Salt Lake City, Utah, United States, 84109
United States, Washington
GSK Investigational Site
Wenatchee, Washington, United States, 98801
Australia, Queensland
GSK Investigational Site
Herston, Queensland, Australia, 4029
Australia, Victoria
GSK Investigational Site
Box Hill, Victoria, Australia, 3128
GSK Investigational Site
St Albans, Victoria, Australia, 3021
Canada, Nova Scotia
GSK Investigational Site
Truro, Nova Scotia, Canada, B2N 1L2
Canada, Ontario
GSK Investigational Site
Kitchener, Ontario, Canada, N2G 1E8
GSK Investigational Site
Sudbury, Ontario, Canada, P3E 1H5
Canada, Quebec
GSK Investigational Site
Quebec City, Quebec, Canada, G1E 7G9
GSK Investigational Site
Ste-Foy, Quebec, Canada, G1W 4R4
New Zealand
GSK Investigational Site
Hamilton, New Zealand, 3240
GSK Investigational Site
Rotorua, New Zealand, 3010
GSK Investigational Site
Takapuna Auckland, New Zealand
GSK Investigational Site
Wellington, New Zealand, 6021
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
Results First Received: December 15, 2014
Last Updated: January 5, 2015
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:
hepatitis B
adults
Type 2 diabetes mellitus
Engerix™-B

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

ClinicalTrials.gov processed this record on June 02, 2015