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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01627340
Registration number
NCT01627340
Ethics application status
Date submitted
21/06/2012
Date registered
25/06/2012
Date last updated
31/07/2018
Titles & IDs
Public title
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Engerix™-B in Adults With or Without Type 2 Diabetes Mellitus
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Scientific title
An Open-label Study to Assess the Immunogenicity and Safety of GSK Biologicals' Hepatitis B Vaccine, Engerix™-B in Adults With or Without Type 2 Diabetes Mellitus
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Secondary ID [1]
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115918
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatitis B
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Engerix™-B vaccine
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.
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.
Other interventions: Engerix™-B vaccine
3 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Subjects Seroprotected for Anti- Hepatitis B Surface Antigen (Anti-HBs) Antibodies
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Assessment method [1]
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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).
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Timepoint [1]
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At one month after the third dose of primary vaccination (Month 7)
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Secondary outcome [1]
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Anti-HBs Antibody Concentration
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Assessment method [1]
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Concentrations were given as geometric mean concentration (GMC) and expressed as mIU/mL
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Timepoint [1]
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At one month after the third dose of primary vaccination (Month 7)
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Secondary outcome [2]
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Number of Subjects Reporting Any Solicited Local Symptoms
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Assessment method [2]
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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.
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Timepoint [2]
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During the 4-day (Days 0-3) post-vaccination period
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Secondary outcome [3]
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Number of Subjects Reporting Any Solicited General Symptoms
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Assessment method [3]
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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)
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Timepoint [3]
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During the 4-day (Days 0-3) post-vaccination period
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Secondary outcome [4]
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Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
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Assessment method [4]
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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.
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Timepoint [4]
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During the 31-day (Days 0-30) post-vaccination period
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Secondary outcome [5]
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Number of Subjects Reporting Any Serious Adverse Events (SAEs)
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Assessment method [5]
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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.
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Timepoint [5]
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During the entire study period (Month 0 - Month 7)
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Eligibility
Key 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.
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Minimum age
20
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/07/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
18/12/2013
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Sample size
Target
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Accrual to date
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Final
667
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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GSK Investigational Site - Herston
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Recruitment hospital [2]
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GSK Investigational Site - Box Hill
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Recruitment hospital [3]
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GSK Investigational Site - St Albans
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Recruitment postcode(s) [1]
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4029 - Herston
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Recruitment postcode(s) [2]
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3128 - Box Hill
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Recruitment postcode(s) [3]
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3021 - St Albans
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Country [2]
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United States of America
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State/province [2]
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Georgia
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Country [3]
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United States of America
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State/province [3]
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Idaho
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Country [4]
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United States of America
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State/province [4]
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Indiana
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Country [5]
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United States of America
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State/province [5]
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Kansas
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Country [6]
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United States of America
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State/province [6]
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New York
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Country [7]
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United States of America
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State/province [7]
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Ohio
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Country [8]
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United States of America
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State/province [8]
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Tennessee
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Country [9]
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United States of America
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State/province [9]
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Utah
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Country [10]
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United States of America
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State/province [10]
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Washington
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Country [11]
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Canada
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State/province [11]
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Nova Scotia
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Country [12]
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Canada
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State/province [12]
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Ontario
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Country [13]
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Canada
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State/province [13]
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Quebec
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Country [14]
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New Zealand
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State/province [14]
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Hamilton
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Country [15]
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New Zealand
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State/province [15]
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Rotorua
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Country [16]
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New Zealand
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State/province [16]
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Takapuna Auckland
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Country [17]
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New Zealand
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State/province [17]
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Wellington
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01627340
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01627340
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