Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Engerix™-B in Adults With or Without Type 2 Diabetes Mellitus
This study has been completed.
Information provided by (Responsible Party):
First received: June 21, 2012
Last updated: February 13, 2014
Last verified: January 2014
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.
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
||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
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2013 (Final data collection date for primary outcome measure)
Experimental: Diabetes Group
Subjects diagnosed with type 2 diabetes within the past five years.
Intramuscular, three doses
Other Name: HBV
Active Comparator: Control Group
Subjects with no diagnosis or documented history of diabetes.
Intramuscular, three doses
Other Name: HBV
|Ages Eligible for Study:
||20 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01627340
||GSK Clinical Trials
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 21, 2012
||February 13, 2014
||New Zealand: Medsafe
United States: Food and Drug Administration
Canada: Biologics and Genetic Therapies Directorate (BGTD)
Australia: Therapeutic Goods Administration
Keywords provided by GlaxoSmithKline:
Type 2 diabetes mellitus
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 09, 2014
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections
DNA Virus Infections