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

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ClinicalTrials.gov Identifier: NCT01627340
Recruitment Status : Completed
First Posted : June 25, 2012
Results First Posted : January 9, 2015
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Hepatitis B
Intervention Biological: Engerix™-B vaccine
Enrollment 667
Recruitment Details  
Pre-assignment Details There was re-allocation of 7 subjects conducted due to certain discrepancies between subjects’ attributes identified from two different sources and as a result of which, there was an increase in the number of subjects from the 667 subjects targeted initially.
Arm/Group Title Diabetes Group Control Group
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 416 258
Completed 404 254
Not Completed 12 4
Reason Not Completed
Adverse Event             1             0
Lost to Follow-up             8             4
Pregnancy             1             0
Withdrawal by Subject             2             0
Arm/Group Title Diabetes Group Control Group Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 416 258 674
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 416 participants 258 participants 674 participants
53.2  (12.32) 49.6  (13.72) 51.8  (12.98)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 416 participants 258 participants 674 participants
Female
182
  43.8%
152
  58.9%
334
  49.6%
Male
234
  56.3%
106
  41.1%
340
  50.4%
1.Primary Outcome
Title Number of Subjects Seroprotected for Anti- Hepatitis B Surface Antigen (Anti-HBs) Antibodies
Hide Description 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).
Time Frame At one month after the third dose of primary vaccination (Month 7)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who received all 3 doses of the EngerixTM-B vaccine, for whom post-vaccination immunogenicity results were available and for those in the Control Group, a suitable match was available in the Diabetic Group.
Arm/Group Title Diabetes Group Control Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 378 189
Measure Type: Count of Participants
Unit of Measure: Participants
285
  75.4%
155
  82.0%
2.Secondary Outcome
Title Anti-HBs Antibody Concentration
Hide Description Concentrations were given as geometric mean concentration (GMC) and expressed as mIU/mL
Time Frame At one month after the third dose of primary vaccination (Month 7)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who received all 3 doses of the EngerixTM-B vaccine, for whom post-vaccination immunogenicity results were available and for those in the Control Group, a suitable match was available in the Diabetic Group.
Arm/Group Title Diabetes Group Control Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 378 189
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
147.6
(110.2 to 197.8)
384.2
(254.5 to 580.0)
3.Secondary Outcome
Title Number of Subjects Reporting Any Solicited Local Symptoms
Hide Description 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.
Time Frame During the 4-day (Days 0-3) post-vaccination period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on Total Vaccinated cohort, which included all subjects who received at least one study vaccine administration and had symptom sheet completed.
Arm/Group Title Diabetes Group Control Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 413 257
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain
160
  38.7%
115
  44.7%
Any Redness
84
  20.3%
51
  19.8%
Any Swelling
49
  11.9%
19
   7.4%
4.Secondary Outcome
Title Number of Subjects Reporting Any Solicited General Symptoms
Hide Description 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)
Time Frame During the 4-day (Days 0-3) post-vaccination period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on Total Vaccinated cohort, which included all subjects who received at least one study vaccine administration and had symptom sheet completed.
Arm/Group Title Diabetes Group Control Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 413 257
Measure Type: Count of Participants
Unit of Measure: Participants
Any Fatigue
118
  28.6%
69
  26.8%
Any Gastrointestinal symptoms
83
  20.1%
47
  18.3%
Any Headache
97
  23.5%
71
  27.6%
Any Fever
15
   3.6%
8
   3.1%
5.Secondary Outcome
Title Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
Hide Description 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.
Time Frame During the 31-day (Days 0-30) post-vaccination period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least one study vaccine administration.
Arm/Group Title Diabetes Group Control Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 416 258
Measure Type: Count of Participants
Unit of Measure: Participants
150
  36.1%
96
  37.2%
6.Secondary Outcome
Title Number of Subjects Reporting Any Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame During the entire study period (Month 0 - Month 7)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least one study vaccine administration.
Arm/Group Title Diabetes Group Control Group
Hide Arm/Group Description:
Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of EngerixTM-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
Subjects with no diagnosis or documented history of diabetes who received 3 doses of EngerixTM-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 416 258
Measure Type: Count of Participants
Unit of Measure: Participants
16
   3.8%
4
   1.6%
Time Frame Serious Adverse Events: From Month 0 to Month 7; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period.
Adverse Event Reporting Description For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
 
Arm/Group Title Diabetes Group Control Group
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Diabetes Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Diabetes Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   16/416 (3.85%)   4/258 (1.55%) 
Blood and lymphatic system disorders     
Leukocytosis * 1  0/416 (0.00%)  1/258 (0.39%) 
Cardiac disorders     
Angina unstable * 1  1/416 (0.24%)  0/258 (0.00%) 
Mitral valve disease * 1  0/416 (0.00%)  1/258 (0.39%) 
Myocardial infarction * 1  1/416 (0.24%)  0/258 (0.00%) 
Gastrointestinal disorders     
Intestinal obstruction * 1  0/416 (0.00%)  1/258 (0.39%) 
General disorders     
Oedema peripheral * 1  1/416 (0.24%)  0/258 (0.00%) 
Hepatobiliary disorders     
Cholelithiasis * 1  1/416 (0.24%)  0/258 (0.00%) 
Immune system disorders     
Anaphylactic reaction * 1  1/416 (0.24%)  0/258 (0.00%) 
Infections and infestations     
Appendicitis * 1  1/416 (0.24%)  0/258 (0.00%) 
Cellulitis * 1  1/416 (0.24%)  0/258 (0.00%) 
Gastroenteritis * 1  0/416 (0.00%)  1/258 (0.39%) 
Infected skin ulcer * 1  1/416 (0.24%)  0/258 (0.00%) 
Mediastinitis * 1  0/416 (0.00%)  1/258 (0.39%) 
Pelvic inflammatory disease * 1  0/416 (0.00%)  1/258 (0.39%) 
Injury, poisoning and procedural complications     
Concussion * 1  1/416 (0.24%)  0/258 (0.00%) 
Incisional hernia, obstructive * 1  1/416 (0.24%)  0/258 (0.00%) 
Radius fracture * 1  1/416 (0.24%)  0/258 (0.00%) 
Rib fracture * 1  1/416 (0.24%)  0/258 (0.00%) 
Scapula fracture * 1  1/416 (0.24%)  0/258 (0.00%) 
Metabolism and nutrition disorders     
Dehydration * 1  1/416 (0.24%)  1/258 (0.39%) 
Hypomagnesaemia * 1  0/416 (0.00%)  1/258 (0.39%) 
Hyponatraemia * 1  0/416 (0.00%)  1/258 (0.39%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion * 1  1/416 (0.24%)  0/258 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Brain neoplasm malignant * 1  1/416 (0.24%)  0/258 (0.00%) 
Glioblastoma multiforme * 1  1/416 (0.24%)  0/258 (0.00%) 
Non-Hodgkin’s lymphoma * 1  1/416 (0.24%)  0/258 (0.00%) 
Papillary thyroid cancer * 1  1/416 (0.24%)  0/258 (0.00%) 
Nervous system disorders     
Syncope * 1  0/416 (0.00%)  1/258 (0.39%) 
Renal and urinary disorders     
Renal failure * 1  1/416 (0.24%)  0/258 (0.00%) 
Renal failure acute * 1  0/416 (0.00%)  1/258 (0.39%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion * 1  1/416 (0.24%)  0/258 (0.00%) 
Pneumothorax * 1  1/416 (0.24%)  0/258 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Diabetes Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   247/416 (59.38%)   168/258 (65.12%) 
General disorders     
Pain  1  160/416 (38.46%)  115/258 (44.57%) 
Redness  1  84/416 (20.19%)  51/258 (19.77%) 
Swelling  1  49/416 (11.78%)  19/258 (7.36%) 
Fatigue  1  118/416 (28.37%)  69/258 (26.74%) 
Gastrointestinal symptoms  1  83/416 (19.95%)  47/258 (18.22%) 
Headache  1  97/416 (23.32%)  71/258 (27.52%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01627340     History of Changes
Other Study ID Numbers: 115918
First Submitted: June 21, 2012
First Posted: June 25, 2012
Results First Submitted: December 15, 2014
Results First Posted: January 9, 2015
Last Update Posted: July 31, 2018