Trial Outcomes & Findings for Immunogenicity and Safety of Sci-B-Vac® to Engerix-B® in Adults (NCT NCT03393754)
NCT ID: NCT03393754
Last Updated: 2020-07-17
Results Overview
To demonstrate that the SPR 4 weeks after completion of the three-dose regimen of Sci-B-Vac® is non-inferior to a three-dose regimen of Engerix-B® in adults ≥18 years old; i.e. the lower bound of the 95% two-sided confidence interval (CI) of the difference between the SPR in the Sci-B-Vac® arm minus the SPR in the Engerix-B® arm, achieved 4 weeks after the third vaccination, will be \> - 5%.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1607 participants
Primary outcome timeframe
Day 196
Results posted on
2020-07-17
Participant Flow
Participant milestones
| Measure |
Engerix-B® Hepatitis B Vaccination
Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, intramuscular (IM) injection at Days 0, 28, and 168.
Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
Sci-B-Vac® Hepatitis B Vaccination
Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, intramuscular (IM) injection at Days 0, 28, and 168.
Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
|---|---|---|
|
Overall Study
STARTED
|
811
|
796
|
|
Overall Study
COMPLETED
|
785
|
758
|
|
Overall Study
NOT COMPLETED
|
26
|
38
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immunogenicity and Safety of Sci-B-Vac® to Engerix-B® in Adults
Baseline characteristics by cohort
| Measure |
Engerix-B® Hepatitis B Vaccination
n=811 Participants
Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, IM injection at Days 0, 28, and 168.
Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
Sci-B-Vac® Hepatitis B Vaccination
n=796 Participants
Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, IM injection at Days 0, 28, and 168.
Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
Total
n=1607 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.6 years
STANDARD_DEVIATION 13.46 • n=5 Participants
|
56.6 years
STANDARD_DEVIATION 13.2 • n=7 Participants
|
56.6 years
STANDARD_DEVIATION 58.0 • n=5 Participants
|
|
Age, Customized
18-44 years
|
154 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
299 Participants
n=5 Participants
|
|
Age, Customized
45-64 years
|
361 Participants
n=5 Participants
|
355 Participants
n=7 Participants
|
716 Participants
n=5 Participants
|
|
Age, Customized
≥ 65 years
|
296 Participants
n=5 Participants
|
296 Participants
n=7 Participants
|
592 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
508 Participants
n=5 Participants
|
481 Participants
n=7 Participants
|
989 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
303 Participants
n=5 Participants
|
315 Participants
n=7 Participants
|
618 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
75 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
732 Participants
n=5 Participants
|
714 Participants
n=7 Participants
|
1446 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
730 Participants
n=5 Participants
|
715 Participants
n=7 Participants
|
1445 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
65 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
133 participants
n=5 Participants
|
126 participants
n=7 Participants
|
259 participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
336 participants
n=5 Participants
|
332 participants
n=7 Participants
|
668 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
342 participants
n=5 Participants
|
338 participants
n=7 Participants
|
680 participants
n=5 Participants
|
|
BMI category
>30 kg/m^2
|
292 Participants
n=5 Participants
|
297 Participants
n=7 Participants
|
589 Participants
n=5 Participants
|
|
BMI category
<=30 kg/m^2
|
519 Participants
n=5 Participants
|
499 Participants
n=7 Participants
|
1018 Participants
n=5 Participants
|
|
Smoking status/Tobacco use
Current smoker/tobacco user
|
113 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
217 Participants
n=5 Participants
|
|
Smoking status/Tobacco use
Former smoker/tobacco user
|
224 Participants
n=5 Participants
|
203 Participants
n=7 Participants
|
427 Participants
n=5 Participants
|
|
Smoking status/Tobacco use
Non-smoker/non-tobacco user
|
474 Participants
n=5 Participants
|
489 Participants
n=7 Participants
|
963 Participants
n=5 Participants
|
|
Diabetes status
Diabetic
|
65 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Diabetes status
Non-diabetic
|
746 Participants
n=5 Participants
|
736 Participants
n=7 Participants
|
1482 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 196Population: Per-protocol set - all subjects in the full analysis set who received all 3 injections, had at least baseline and 1 post-baseline immunogenicity assessment (at the time point of interest), were seronegative at baseline, and had no major protocol deviations leading to exclusion.
To demonstrate that the SPR 4 weeks after completion of the three-dose regimen of Sci-B-Vac® is non-inferior to a three-dose regimen of Engerix-B® in adults ≥18 years old; i.e. the lower bound of the 95% two-sided confidence interval (CI) of the difference between the SPR in the Sci-B-Vac® arm minus the SPR in the Engerix-B® arm, achieved 4 weeks after the third vaccination, will be \> - 5%.
Outcome measures
| Measure |
Engerix-B® Hepatitis B Vaccination
n=723 Participants
Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, IM injection at Days 0, 28, and 168.
Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
Sci-B-Vac® Hepatitis B Vaccination
n=718 Participants
Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, IM injection at Days 0, 28, and 168.
Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
|---|---|---|
|
Seroprotection Rate (SPR) Defined as Percentage of Adults ≥ 18 Years Old Achieving Anti-HBs Levels of ≥10 mIU/mL in Serum at Study Day 196
|
76.49 percentage of participants seroprotected
Interval 73.22 to 79.53
|
91.36 percentage of participants seroprotected
Interval 89.07 to 93.32
|
PRIMARY outcome
Timeframe: Day 196Population: Full analysis set - subjects who received at least 1 injection and had at least baseline and 1 post baseline immunogenicity assessment.
To demonstrate that the SPR 4 weeks after completion of the three-dose regimen of Sci-B-Vac® is superior to the SPR 4 weeks after completion of the three-dose regimen of Engerix-B® in older adults ≥ 45 years old i.e. the lower bound of the 95% two-sided CI of the difference between the SPR in the Sci-B-Vac® arm minus the SPR in the Engerix-B® arm, achieved 4 weeks after receiving the third vaccination, will be \> 5%.
Outcome measures
| Measure |
Engerix-B® Hepatitis B Vaccination
n=627 Participants
Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, IM injection at Days 0, 28, and 168.
Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
Sci-B-Vac® Hepatitis B Vaccination
n=625 Participants
Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, IM injection at Days 0, 28, and 168.
Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
|---|---|---|
|
Seroprotection Rate (SPR) Defined as Percentage of Adults ≥ 45 Years Old Achieving Anti-HBs Levels of ≥10 mIU/mL in Serum at Study Day 196
|
73.05 percentage of participants seroprotected
Interval 69.39 to 76.48
|
89.44 percentage of participants seroprotected
Interval 86.76 to 91.74
|
SECONDARY outcome
Timeframe: Day of vaccine administration and six subsequent daysPopulation: Safety set: all subjects in the All Enrolled Set who received at least 1 injection
Analysis of local and systemic solicited adverse events with an interval of onset of Day 1 to Day 7 after any vaccination with either Sci-B-Vac® or Engerix-B®, in adults ≥18 years old.
Outcome measures
| Measure |
Engerix-B® Hepatitis B Vaccination
n=811 Participants
Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, IM injection at Days 0, 28, and 168.
Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
Sci-B-Vac® Hepatitis B Vaccination
n=796 Participants
Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, IM injection at Days 0, 28, and 168.
Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
|---|---|---|
|
Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs)
Pain
|
294 Participants
|
503 Participants
|
|
Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs)
Tenderness
|
282 Participants
|
484 Participants
|
|
Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs)
Pruritus/itching
|
66 Participants
|
76 Participants
|
|
Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs)
Redness/erythema
|
15 Participants
|
18 Participants
|
|
Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs)
Swelling/edema
|
12 Participants
|
18 Participants
|
|
Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs)
Fatigue
|
249 Participants
|
242 Participants
|
|
Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs)
Headache
|
238 Participants
|
249 Participants
|
|
Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs)
Myalgia
|
197 Participants
|
276 Participants
|
|
Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs)
Diarrhea
|
96 Participants
|
82 Participants
|
|
Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs)
Nausea/vomiting
|
73 Participants
|
56 Participants
|
Adverse Events
Engerix-B® Hepatitis B Vaccination
Serious events: 21 serious events
Other events: 455 other events
Deaths: 0 deaths
Sci-B-Vac® Hepatitis B Vaccination
Serious events: 32 serious events
Other events: 429 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Engerix-B® Hepatitis B Vaccination
n=811 participants at risk
Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, IM injection at Days 0, 28, and 168.
Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
Sci-B-Vac® Hepatitis B Vaccination
n=796 participants at risk
Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, IM injection at Days 0, 28, and 168.
Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.25%
2/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.13%
1/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.25%
2/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.12%
1/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.13%
1/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.12%
1/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.13%
1/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.12%
1/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.13%
1/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.25%
2/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.12%
1/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.13%
1/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.13%
1/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.12%
1/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.13%
1/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Cardiac disorders
Nodal arrhythmia
|
0.00%
0/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.13%
1/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Congenital, familial and genetic disorders
Trisomy 21
|
0.00%
0/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.13%
1/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.13%
1/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.12%
1/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Gastrointestinal disorders
Diaphragmatic hernia
|
0.12%
1/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.12%
1/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.00%
0/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.13%
1/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.13%
1/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
General disorders
Chest pain
|
0.12%
1/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Infections and infestations
Appendicitis
|
0.00%
0/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.13%
1/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.13%
1/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.13%
1/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Infections and infestations
Gastrointestinal infection
|
0.12%
1/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Infections and infestations
Influenza
|
0.00%
0/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.13%
1/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.13%
1/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Infections and infestations
Pyelonephritis acute
|
0.12%
1/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Infections and infestations
Sepsis
|
0.00%
0/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.13%
1/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.13%
1/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Infections and infestations
Urinary tract infection
|
0.12%
1/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Infections and infestations
Urosepsis
|
0.00%
0/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.13%
1/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Injury, poisoning and procedural complications
Back injury
|
0.12%
1/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Injury, poisoning and procedural complications
Head injury
|
0.12%
1/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.13%
1/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.13%
1/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.13%
1/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Investigations
Troponin increased
|
0.12%
1/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.13%
1/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.12%
1/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer stage II
|
0.00%
0/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.13%
1/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.13%
1/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.13%
1/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.12%
1/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.12%
1/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.13%
1/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.13%
1/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.13%
1/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Nervous system disorders
Syncope
|
0.00%
0/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.13%
1/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Pregnancy, puerperium and perinatal conditions
Subchorionic haemorrhage
|
0.00%
0/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.13%
1/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.12%
1/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.12%
1/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.13%
1/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Vascular disorders
Aortic stenosis
|
0.12%
1/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
Other adverse events
| Measure |
Engerix-B® Hepatitis B Vaccination
n=811 participants at risk
Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, IM injection at Days 0, 28, and 168.
Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
Sci-B-Vac® Hepatitis B Vaccination
n=796 participants at risk
Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, IM injection at Days 0, 28, and 168.
Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
21/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
1.5%
12/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Gastrointestinal disorders
Toothache
|
1.2%
10/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.63%
5/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Gastrointestinal disorders
Nausea
|
1.2%
10/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.38%
3/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
General disorders
Fatigue
|
4.9%
40/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
4.3%
34/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
General disorders
Injection site pain
|
1.6%
13/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
2.9%
23/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Infections and infestations
Upper respiratory tract infection
|
7.0%
57/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
6.4%
51/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Infections and infestations
Nasopharyngitis
|
3.9%
32/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
4.6%
37/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Infections and infestations
Urinary tract infection
|
2.1%
17/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
2.3%
18/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Infections and infestations
Sinusitis
|
2.1%
17/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
1.4%
11/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Infections and infestations
Gastroenteritis
|
0.86%
7/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
1.4%
11/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Infections and infestations
Bronchitis
|
0.74%
6/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
1.3%
10/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Infections and infestations
Influenza
|
1.2%
10/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
0.75%
6/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.74%
6/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
1.1%
9/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Investigations
Respiratory rate increased
|
0.86%
7/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
1.3%
10/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.2%
34/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
3.8%
30/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
27/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
4.5%
36/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.8%
23/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
2.1%
17/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
16/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
1.6%
13/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.2%
10/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
1.0%
8/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Nervous system disorders
Headache
|
8.8%
71/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
8.7%
69/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Nervous system disorders
Dizziness
|
1.4%
11/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
1.5%
12/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.2%
18/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
2.0%
16/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
9/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
1.1%
9/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
|
Vascular disorders
Hypertension
|
1.6%
13/811 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
1.3%
10/796 • 1 year
Number (%) of subject-reporting unsolicited adverse events (AEs) and serious adverse events (SAEs).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place