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Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Engerix™-B in Adults With or Without Type 2 Diabetes Mellitus
Phase 4 trial testing Engerix™-B vaccine in Hepatitis B in 667 participants. Completed in 18 December 2013.
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 667 |
| Start date | 24 July 2012 |
| Primary completion | 18 December 2013 |
| Estimated completion | 18 December 2013 |
| Sites | 22 locations across New Zealand, Canada, United States, Australia |
GlaxoSmithKline — full company profile →
20 and older, any sex, with Hepatitis B. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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).
| Group | Value | 95% CI |
|---|---|---|
| Diabetes Group | 285 | |
| Control Group | 155 |
Concentrations were given as geometric mean concentration (GMC) and expressed as mIU/mL
| Group | Value | 95% CI |
|---|---|---|
| Diabetes Group | 147.6 | 110.2 – 197.8 |
| Control Group | 384.2 | 254.5 – 580.0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Diabetes Group | 160 | |
| Control Group | 115 |
| Group | Value | 95% CI |
|---|---|---|
| Diabetes Group | 84 | |
| Control Group | 51 |
| Group | Value | 95% CI |
|---|---|---|
| Diabetes Group | 49 | |
| Control Group | 19 |
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)
| Group | Value | 95% CI |
|---|---|---|
| Diabetes Group | 118 | |
| Control Group | 69 |
| Group | Value | 95% CI |
|---|---|---|
| Diabetes Group | 83 | |
| Control Group | 47 |
| Group | Value | 95% CI |
|---|---|---|
| Diabetes Group | 97 | |
| Control Group | 71 |
| Group | Value | 95% CI |
|---|---|---|
| Diabetes Group | 15 | |
| Control Group | 8 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Diabetes Group | 150 | |
| Control Group | 96 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Diabetes Group | 16 | |
| Control Group | 4 |
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.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Diabetes Group | Control Group |
|---|---|---|---|
| Dehydration | Metabolism and nutrition disorders | — | — |
| Anaphylactic reaction | Immune system disorders | — | — |
| Angina unstable | Cardiac disorders | — | — |
| Appendicitis | Infections and infestations | — | — |
| Brain neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Cellulitis | Infections and infestations | — | — |
| Cholelithiasis | Hepatobiliary disorders | — | — |
| Concussion | Injury, poisoning and procedural complications | — | — |
| Gastroenteritis | Infections and infestations | — | — |
| Glioblastoma multiforme | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Hypomagnesaemia | Metabolism and nutrition disorders | — | — |
| Hyponatraemia | Metabolism and nutrition disorders | — | — |
| Incisional hernia, obstructive | Injury, poisoning and procedural complications | — | — |
| Infected skin ulcer | Infections and infestations | — | — |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | — | — |
| Intestinal obstruction | Gastrointestinal disorders | — | — |
| Leukocytosis | Blood and lymphatic system disorders | — | — |
| Mediastinitis | Infections and infestations | — | — |
| Mitral valve disease | Cardiac disorders | — | — |
| Myocardial infarction | Cardiac disorders | — | — |
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Oedema peripheral | General disorders | — | — |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Pelvic inflammatory disease | Infections and infestations | — | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — | — |
| Reaction | System | Diabetes Group | Control Group |
|---|---|---|---|
| Pain | General disorders | — | — |
| Fatigue | General disorders | — | — |
| Headache | General disorders | — | — |
| Redness | General disorders | — | — |
| Gastrointestinal symptoms | General disorders | — | — |
| Swelling | General disorders | — | — |
Most-reported serious reactions: Dehydration, Anaphylactic reaction, Angina unstable, Appendicitis, Brain neoplasm malignant, Cellulitis, Cholelithiasis, Concussion.
Data from ClinicalTrials.gov NCT01627340 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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