Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Engerix™-B in Adults With or Without Type 2 Diabetes Mellitus
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
1 other identifier
interventional
667
4 countries
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2012
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2012
CompletedFirst Posted
Study publicly available on registry
June 25, 2012
CompletedStudy Start
First participant enrolled
July 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 18, 2013
CompletedResults Posted
Study results publicly available
January 9, 2015
CompletedJuly 31, 2018
January 1, 2017
1.4 years
June 21, 2012
December 15, 2014
July 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Subjects Seroprotected for Anti- Hepatitis B Surface Antigen (Anti-HBs) Antibodies
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).
At one month after the third dose of primary vaccination (Month 7)
Secondary Outcomes (5)
Anti-HBs Antibody Concentration
At one month after the third dose of primary vaccination (Month 7)
Number of Subjects Reporting Any Solicited Local Symptoms
During the 4-day (Days 0-3) post-vaccination period
Number of Subjects Reporting Any Solicited General Symptoms
During the 4-day (Days 0-3) post-vaccination period
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
During the 31-day (Days 0-30) post-vaccination period
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
During the entire study period (Month 0 - Month 7)
Study Arms (2)
Diabetes Group
EXPERIMENTALSubjects 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.
Control Group
ACTIVE COMPARATORSubjects 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.
Interventions
3 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (22)
GSK Investigational Site
Huntsville, Alabama, 35802, United States
GSK Investigational Site
Stockbridge, Georgia, 30281, United States
GSK Investigational Site
Boise, Idaho, 83642, United States
GSK Investigational Site
Mishawaka, Indiana, 46545, United States
GSK Investigational Site
Wichita, Kansas, 67207, United States
GSK Investigational Site
Endwell, New York, 13760, United States
GSK Investigational Site
Cleveland, Ohio, 44122, United States
GSK Investigational Site
Nashville, Tennessee, 37203, United States
GSK Investigational Site
Salt Lake City, Utah, 84109, United States
GSK Investigational Site
Wenatchee, Washington, 98801, United States
GSK Investigational Site
Herston, Queensland, 4029, Australia
GSK Investigational Site
Box Hill, Victoria, 3128, Australia
GSK Investigational Site
St Albans, Victoria, 3021, Australia
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2, Canada
GSK Investigational Site
Greater Sudbury, Ontario, P3E 1H5, Canada
GSK Investigational Site
Kitchener, Ontario, N2G 1E8, Canada
GSK Investigational Site
Québec, Quebec, G1E 7G9, Canada
GSK Investigational Site
Ste-Foy, Quebec, G1W 4R4, Canada
GSK Investigational Site
Hamilton, 3240, New Zealand
GSK Investigational Site
Rotorua, 3010, New Zealand
GSK Investigational Site
Takapuna Auckland, New Zealand
GSK Investigational Site
Wellington, 6021, New Zealand
Related Publications (1)
Van Der Meeren O, Peterson JT, Dionne M, Beasley R, Ebeling PR, Ferguson M, Nissen MD, Rheault P, Simpson RW, De Ridder M, Crasta PD, Miller JM, Trofa AF. Prospective clinical trial of hepatitis B vaccination in adults with and without type-2 diabetes mellitus. Hum Vaccin Immunother. 2016 Aug 2;12(8):2197-2203. doi: 10.1080/21645515.2016.1164362. Epub 2016 Apr 28.
PMID: 27123743DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2012
First Posted
June 25, 2012
Study Start
July 24, 2012
Primary Completion
December 18, 2013
Study Completion
December 18, 2013
Last Updated
July 31, 2018
Results First Posted
January 9, 2015
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.