Trial Outcomes & Findings for Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Engerix™-B in Adults With or Without Type 2 Diabetes Mellitus (NCT NCT01627340)

Last Updated: 2018-07-31

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

667 participants

Primary outcome timeframe

At one month after the third dose of primary vaccination (Month 7)

Results posted on

2018-07-31

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	416	258
Overall Study COMPLETED	404	254
Overall Study NOT COMPLETED	12	4

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Adverse Event	1	0
Overall Study Lost to Follow-up	8	4
Overall Study Pregnancy	1	0
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diabetes Group n=416 Participants 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.	Control Group n=258 Participants 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 n=674 Participants Total of all reporting groups
Age, Continuous	53.2 Years STANDARD_DEVIATION 12.32 • n=5 Participants	49.6 Years STANDARD_DEVIATION 13.72 • n=7 Participants	51.8 Years STANDARD_DEVIATION 12.98 • n=5 Participants
Sex: Female, Male Female	182 Participants n=5 Participants	152 Participants n=7 Participants	334 Participants n=5 Participants
Sex: Female, Male Male	234 Participants n=5 Participants	106 Participants n=7 Participants	340 Participants n=5 Participants

PRIMARY outcome

Timeframe: At one month after the third dose of primary vaccination (Month 7)

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Diabetes Group n=378 Participants 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.	Control Group n=189 Participants 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.
Number of Subjects Seroprotected for Anti- Hepatitis B Surface Antigen (Anti-HBs) Antibodies	285 Participants	155 Participants

SECONDARY outcome

Timeframe: At one month after the third dose of primary vaccination (Month 7)

Concentrations were given as geometric mean concentration (GMC) and expressed as mIU/mL

Outcome measures

Outcome measures
Measure	Diabetes Group n=378 Participants 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.	Control Group n=189 Participants 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.
Anti-HBs Antibody Concentration	147.6 mIU/mL Interval 110.2 to 197.8	384.2 mIU/mL Interval 254.5 to 580.0

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-vaccination period

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Diabetes Group n=413 Participants 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.	Control Group n=257 Participants 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.
Number of Subjects Reporting Any Solicited Local Symptoms Any Swelling	49 Participants	19 Participants
Number of Subjects Reporting Any Solicited Local Symptoms Any Pain	160 Participants	115 Participants
Number of Subjects Reporting Any Solicited Local Symptoms Any Redness	84 Participants	51 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-vaccination period

Population: 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.

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)

Outcome measures

Outcome measures
Measure	Diabetes Group n=413 Participants 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.	Control Group n=257 Participants 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.
Number of Subjects Reporting Any Solicited General Symptoms Any Fatigue	118 Participants	69 Participants
Number of Subjects Reporting Any Solicited General Symptoms Any Gastrointestinal symptoms	83 Participants	47 Participants
Number of Subjects Reporting Any Solicited General Symptoms Any Headache	97 Participants	71 Participants
Number of Subjects Reporting Any Solicited General Symptoms Any Fever	15 Participants	8 Participants

SECONDARY outcome

Timeframe: During the 31-day (Days 0-30) post-vaccination period

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least one study vaccine administration.

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.

Outcome measures

Outcome measures
Measure	Diabetes Group n=416 Participants 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.	Control Group n=258 Participants 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.
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)	150 Participants	96 Participants

SECONDARY outcome

Timeframe: During the entire study period (Month 0 - Month 7)

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least one study vaccine administration.

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.

Outcome measures

Outcome measures
Measure	Diabetes Group n=416 Participants 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.	Control Group n=258 Participants 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.
Number of Subjects Reporting Any Serious Adverse Events (SAEs)	16 Participants	4 Participants

Adverse Events

Diabetes Group

Serious events: 16 serious events

Other events: 247 other events

Deaths: 0 deaths

Control Group

Serious events: 4 serious events

Other events: 168 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Diabetes Group n=416 participants at risk 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.	Control Group n=258 participants at risk 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.
General disorders Pain	38.5% 160/416 • Serious Adverse Events: From Month 0 to Month 7; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period. 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.	44.6% 115/258 • Serious Adverse Events: From Month 0 to Month 7; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period. 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.
General disorders Redness	20.2% 84/416 • Serious Adverse Events: From Month 0 to Month 7; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period. 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.	19.8% 51/258 • Serious Adverse Events: From Month 0 to Month 7; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period. 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.
General disorders Swelling	11.8% 49/416 • Serious Adverse Events: From Month 0 to Month 7; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period. 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.	7.4% 19/258 • Serious Adverse Events: From Month 0 to Month 7; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period. 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.
General disorders Fatigue	28.4% 118/416 • Serious Adverse Events: From Month 0 to Month 7; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period. 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.	26.7% 69/258 • Serious Adverse Events: From Month 0 to Month 7; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period. 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.
General disorders Gastrointestinal symptoms	20.0% 83/416 • Serious Adverse Events: From Month 0 to Month 7; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period. 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.	18.2% 47/258 • Serious Adverse Events: From Month 0 to Month 7; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period. 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.
General disorders Headache	23.3% 97/416 • Serious Adverse Events: From Month 0 to Month 7; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period. 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.	27.5% 71/258 • Serious Adverse Events: From Month 0 to Month 7; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period. 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.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER