Trial Outcomes & Findings for Safety and Immunogenicity of Recombinant Hepatitis B Vaccine Sci-B-Vac® Compared to Engerix-B® (NCT NCT04209400)
NCT ID: NCT04209400
Last Updated: 2022-07-25
Results Overview
Percentage of subjects with an anti-HBs antibody level ≥ 2.1 mIU/mL 30 days after the last of three vaccinations. Seroconversion is defined as the development of a detectable anti-HBs antibody level above an established threshold of 2.1 mIU/mL.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
100 participants
Primary outcome timeframe
Day 210
Results posted on
2022-07-25
Participant Flow
Participant milestones
| Measure |
Sci-B-Vac®
Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, IM injection at Days 1, 28 and 180 Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
Engerix-B®
Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, IM injection at Days 0, 28, and 180.
Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
49
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Sci-B-Vac®
Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, IM injection at Days 1, 28 and 180 Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
Engerix-B®
Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, IM injection at Days 0, 28, and 180.
Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Safety and Immunogenicity of Recombinant Hepatitis B Vaccine Sci-B-Vac® Compared to Engerix-B®
Baseline characteristics by cohort
| Measure |
Sci-B-Vac®
n=50 Participants
Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, IM injection at Days 0, 28, and 180.
Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
Engerix-B®
n=50 Participants
Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, IM injection at Days 0, 28, and 180.
Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
28.38 years
STANDARD_DEVIATION 7.72 • n=5 Participants
|
30.56 years
STANDARD_DEVIATION 8.13 • n=7 Participants
|
29.47 years
STANDARD_DEVIATION 7.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian-Russians
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 210Population: The primary analysis was performed on the intent-to-treat (ITT) set, which included all participants randomized. Analysis of the study parameters for vaccine immunogenicity was performed for all subjects included in the vaccine groups who received at least one injection, if at least one assessment after the start of the vaccination was available.
Percentage of subjects with an anti-HBs antibody level ≥ 2.1 mIU/mL 30 days after the last of three vaccinations. Seroconversion is defined as the development of a detectable anti-HBs antibody level above an established threshold of 2.1 mIU/mL.
Outcome measures
| Measure |
Sci-B-Vac®
n=47 Participants
Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, intramuscular (IM) injection at Days 0, 28, and 180.
Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
Engerix-B®
n=47 Participants
Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, intramuscular (IM) injection at Days 0, 28, and 180.
Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
|---|---|---|
|
Seroconversion Rate
|
47 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: Days 1, 28, 90, 180, 210Population: The analysis was performed on the intent-to-treat (ITT) set, which included all participants randomized. Analysis of the study parameters for vaccine immunogenicity was performed for all subjects included in the vaccine groups who received at least one injection, if at least one assessment after the start of the vaccination was available.
Percentage of subjects with an anti-HBs antibody level ≥ 10 mIU/mL prior to vaccination, 28 days after the first vaccination, 60 and 150 days after the second vaccination and 30 days after the third vaccination. The development of an anti-HBs antibody level of at least 10 mIU/mL is an established surrogate of seroprotection and correlate of protective immunity against HBV.
Outcome measures
| Measure |
Sci-B-Vac®
n=50 Participants
Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, intramuscular (IM) injection at Days 0, 28, and 180.
Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
Engerix-B®
n=49 Participants
Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, intramuscular (IM) injection at Days 0, 28, and 180.
Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
|---|---|---|
|
Seroprotection Rate
Day 1
|
0 Participants
|
0 Participants
|
|
Seroprotection Rate
Day 28
|
30 Participants
|
24 Participants
|
|
Seroprotection Rate
Day 90
|
47 Participants
|
41 Participants
|
|
Seroprotection Rate
Day 180
|
47 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: Days 1, 28, 90, 180Population: The analysis was performed on the intent-to-treat (ITT) set, which included all participants randomized. Analysis of the study parameters for vaccine immunogenicity was performed for all subjects included in the vaccine groups who received at least one injection, if at least one assessment after the start of the vaccination was available.
Percentage of subjects with an anti-HBs antibody level ≥ 2.1 mIU/mL prior to vaccination, 28 days after the first vaccination and 60 and 150 days after the second vaccination. Seroconversion is defined as the development of a detectable anti-HBs antibody level above an established threshold of 2.1 mIU/mL.
Outcome measures
| Measure |
Sci-B-Vac®
n=50 Participants
Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, intramuscular (IM) injection at Days 0, 28, and 180.
Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
Engerix-B®
n=49 Participants
Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, intramuscular (IM) injection at Days 0, 28, and 180.
Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
|---|---|---|
|
Seroconversion Rate
Day 1
|
0 Participants
|
0 Participants
|
|
Seroconversion Rate
Day 28
|
46 Participants
|
36 Participants
|
|
Seroconversion Rate
Day 90
|
48 Participants
|
45 Participants
|
|
Seroconversion Rate
Day 180
|
47 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: Days 1, 28, 90, 180, and 210Population: The analysis was performed on the intent-to-treat (ITT) set, which included all participants randomized. Analysis of the study parameters for vaccine immunogenicity was performed for all subjects included in the vaccine groups who received at least one injection, if at least one assessment after the start of the vaccination was available.
Geometric mean concentration of anti-HBs antibody in mIU/mL 28 days after the first vaccination, 60 and 150 days after the second vaccination, and 30 days after the third vaccination.
Outcome measures
| Measure |
Sci-B-Vac®
n=50 Participants
Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, intramuscular (IM) injection at Days 0, 28, and 180.
Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
Engerix-B®
n=49 Participants
Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, intramuscular (IM) injection at Days 0, 28, and 180.
Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
|---|---|---|
|
Geometric Mean Concentrations (GMC) of HBs Antibodies
Day 90
|
618.3 mIU/mL
Standard Deviation 404.2
|
378.7 mIU/mL
Standard Deviation 417.9
|
|
Geometric Mean Concentrations (GMC) of HBs Antibodies
Day 180
|
757.7 mIU/mL
Standard Deviation 378.0
|
441.3 mIU/mL
Standard Deviation 437.6
|
|
Geometric Mean Concentrations (GMC) of HBs Antibodies
Day 210
|
891.4 mIU/mL
Standard Deviation 253.7
|
787.0 mIU/mL
Standard Deviation 351.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1, Day 2, and Day 28Population: The analysis of safety and tolerability was conducted in the population of subjects included in the study meeting the inclusion criteria while complying with the exclusion criteria, who received at least one dose of the experimental vaccine.
Incidence of mild erythema at the injection site 1, 2 and 28 days after the first vaccination.
Outcome measures
| Measure |
Sci-B-Vac®
n=50 Participants
Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, intramuscular (IM) injection at Days 0, 28, and 180.
Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
Engerix-B®
n=49 Participants
Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, intramuscular (IM) injection at Days 0, 28, and 180.
Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
|---|---|---|
|
Adverse Events: Local Reactions at the Injection Site- Incidence of Redness
Day 28
|
3 Participants
|
0 Participants
|
|
Adverse Events: Local Reactions at the Injection Site- Incidence of Redness
Day 1
|
8 Participants
|
4 Participants
|
|
Adverse Events: Local Reactions at the Injection Site- Incidence of Redness
Day 2
|
2 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1-5, Days 28-32, Day 90, Days 180-185, Day 210Population: The analysis of safety and tolerability was conducted in the population of subjects included in the study meeting the inclusion criteria while complying with the exclusion criteria, who received at least one dose of the experimental vaccine.
Incidence of itchiness at the injection site at any point throughout the trial. Itchiness was assessed for 5 days following vaccinations on Days 1, 28, and 180 and also assessed on Day 90 and Day 210.
Outcome measures
| Measure |
Sci-B-Vac®
n=50 Participants
Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, intramuscular (IM) injection at Days 0, 28, and 180.
Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
Engerix-B®
n=49 Participants
Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, intramuscular (IM) injection at Days 0, 28, and 180.
Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
|---|---|---|
|
Adverse Events: Local Reactions at the Injection Site - Incidence of Itch
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1, 28, 180Population: The analysis of safety and tolerability was conducted in the population of subjects included in the study meeting the inclusion criteria while complying with the exclusion criteria, who received at least one dose of the experimental vaccine.
Incidence of pain at the injection site on the day of vaccination. Vaccination was performed on Day 1, Day 28, and Day 180.
Outcome measures
| Measure |
Sci-B-Vac®
n=50 Participants
Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, intramuscular (IM) injection at Days 0, 28, and 180.
Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
Engerix-B®
n=49 Participants
Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, intramuscular (IM) injection at Days 0, 28, and 180.
Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
|---|---|---|
|
Adverse Events: Local Reactions at the Injection Site - Incidence of Pain
Day 1
|
7 Participants
|
8 Participants
|
|
Adverse Events: Local Reactions at the Injection Site - Incidence of Pain
Day 28
|
8 Participants
|
7 Participants
|
|
Adverse Events: Local Reactions at the Injection Site - Incidence of Pain
Day 180
|
7 Participants
|
11 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1, 28, 180Population: The analysis of safety and tolerability was conducted in the population of subjects included in the study meeting the inclusion criteria while complying with the exclusion criteria, who received at least one dose of the experimental vaccine.
Pain was evaluated 30 minutes after each vaccination by the subject using the visual analogue scale. A higher score indicates greater pain intensity.
Outcome measures
| Measure |
Sci-B-Vac®
n=50 Participants
Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, intramuscular (IM) injection at Days 0, 28, and 180.
Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
Engerix-B®
n=49 Participants
Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, intramuscular (IM) injection at Days 0, 28, and 180.
Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
|---|---|---|
|
Adverse Events: Local Reactions at the Injection Site - Intensity of Pain
Day 1 : Pains score 1
|
43 Participants
|
41 Participants
|
|
Adverse Events: Local Reactions at the Injection Site - Intensity of Pain
Day 1 : Pain score 2
|
5 Participants
|
6 Participants
|
|
Adverse Events: Local Reactions at the Injection Site - Intensity of Pain
Day 1 : Pain score 3
|
2 Participants
|
2 Participants
|
|
Adverse Events: Local Reactions at the Injection Site - Intensity of Pain
Day 28 : Pain score 1
|
42 Participants
|
41 Participants
|
|
Adverse Events: Local Reactions at the Injection Site - Intensity of Pain
Day 28 : Pain score 2
|
7 Participants
|
6 Participants
|
|
Adverse Events: Local Reactions at the Injection Site - Intensity of Pain
Day 28 : Pain score 3
|
1 Participants
|
1 Participants
|
|
Adverse Events: Local Reactions at the Injection Site - Intensity of Pain
Day 180 : Pain score 1
|
40 Participants
|
36 Participants
|
|
Adverse Events: Local Reactions at the Injection Site - Intensity of Pain
Day 180 : Pain score 2
|
7 Participants
|
9 Participants
|
|
Adverse Events: Local Reactions at the Injection Site - Intensity of Pain
Day 180 : Pain score 3
|
0 Participants
|
2 Participants
|
Adverse Events
Sci-B-Vac®
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Engerix-B®
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sci-B-Vac®
n=50 participants at risk
Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, intramuscular (IM) injection at Days 0, 28, and 180.
Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
Engerix-B®
n=49 participants at risk
Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, intramuscular (IM) injection at Days 0, 28, and 180.
Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
|
|---|---|---|
|
General disorders
Hyperthermia
|
0.00%
0/50 • Through study completion, approximately 7 months.
An AE is any unfavourable sign (including abnormal lab results), symptom, or disease that are time-associated with vaccine use, regardless whether or not they are viewed as having been caused by medicinal products, and whether they are mild or serious. Intensity of the adverse events were defined as Mild: Adverse event that is easily tolerated. Moderate: AEs causing discomfort sufficient for impairment of everyday activity. Severe: Adverse event preventing normal everyday activity
|
2.0%
1/49 • Number of events 1 • Through study completion, approximately 7 months.
An AE is any unfavourable sign (including abnormal lab results), symptom, or disease that are time-associated with vaccine use, regardless whether or not they are viewed as having been caused by medicinal products, and whether they are mild or serious. Intensity of the adverse events were defined as Mild: Adverse event that is easily tolerated. Moderate: AEs causing discomfort sufficient for impairment of everyday activity. Severe: Adverse event preventing normal everyday activity
|
|
Nervous system disorders
drowsiness
|
4.0%
2/50 • Number of events 3 • Through study completion, approximately 7 months.
An AE is any unfavourable sign (including abnormal lab results), symptom, or disease that are time-associated with vaccine use, regardless whether or not they are viewed as having been caused by medicinal products, and whether they are mild or serious. Intensity of the adverse events were defined as Mild: Adverse event that is easily tolerated. Moderate: AEs causing discomfort sufficient for impairment of everyday activity. Severe: Adverse event preventing normal everyday activity
|
4.1%
2/49 • Number of events 2 • Through study completion, approximately 7 months.
An AE is any unfavourable sign (including abnormal lab results), symptom, or disease that are time-associated with vaccine use, regardless whether or not they are viewed as having been caused by medicinal products, and whether they are mild or serious. Intensity of the adverse events were defined as Mild: Adverse event that is easily tolerated. Moderate: AEs causing discomfort sufficient for impairment of everyday activity. Severe: Adverse event preventing normal everyday activity
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/50 • Through study completion, approximately 7 months.
An AE is any unfavourable sign (including abnormal lab results), symptom, or disease that are time-associated with vaccine use, regardless whether or not they are viewed as having been caused by medicinal products, and whether they are mild or serious. Intensity of the adverse events were defined as Mild: Adverse event that is easily tolerated. Moderate: AEs causing discomfort sufficient for impairment of everyday activity. Severe: Adverse event preventing normal everyday activity
|
2.0%
1/49 • Number of events 2 • Through study completion, approximately 7 months.
An AE is any unfavourable sign (including abnormal lab results), symptom, or disease that are time-associated with vaccine use, regardless whether or not they are viewed as having been caused by medicinal products, and whether they are mild or serious. Intensity of the adverse events were defined as Mild: Adverse event that is easily tolerated. Moderate: AEs causing discomfort sufficient for impairment of everyday activity. Severe: Adverse event preventing normal everyday activity
|
|
Nervous system disorders
metallic taste
|
0.00%
0/50 • Through study completion, approximately 7 months.
An AE is any unfavourable sign (including abnormal lab results), symptom, or disease that are time-associated with vaccine use, regardless whether or not they are viewed as having been caused by medicinal products, and whether they are mild or serious. Intensity of the adverse events were defined as Mild: Adverse event that is easily tolerated. Moderate: AEs causing discomfort sufficient for impairment of everyday activity. Severe: Adverse event preventing normal everyday activity
|
2.0%
1/49 • Number of events 2 • Through study completion, approximately 7 months.
An AE is any unfavourable sign (including abnormal lab results), symptom, or disease that are time-associated with vaccine use, regardless whether or not they are viewed as having been caused by medicinal products, and whether they are mild or serious. Intensity of the adverse events were defined as Mild: Adverse event that is easily tolerated. Moderate: AEs causing discomfort sufficient for impairment of everyday activity. Severe: Adverse event preventing normal everyday activity
|
|
Infections and infestations
acute respiratory viral infection
|
0.00%
0/50 • Through study completion, approximately 7 months.
An AE is any unfavourable sign (including abnormal lab results), symptom, or disease that are time-associated with vaccine use, regardless whether or not they are viewed as having been caused by medicinal products, and whether they are mild or serious. Intensity of the adverse events were defined as Mild: Adverse event that is easily tolerated. Moderate: AEs causing discomfort sufficient for impairment of everyday activity. Severe: Adverse event preventing normal everyday activity
|
2.0%
1/49 • Number of events 3 • Through study completion, approximately 7 months.
An AE is any unfavourable sign (including abnormal lab results), symptom, or disease that are time-associated with vaccine use, regardless whether or not they are viewed as having been caused by medicinal products, and whether they are mild or serious. Intensity of the adverse events were defined as Mild: Adverse event that is easily tolerated. Moderate: AEs causing discomfort sufficient for impairment of everyday activity. Severe: Adverse event preventing normal everyday activity
|
|
Infections and infestations
rotavirus infection
|
0.00%
0/50 • Through study completion, approximately 7 months.
An AE is any unfavourable sign (including abnormal lab results), symptom, or disease that are time-associated with vaccine use, regardless whether or not they are viewed as having been caused by medicinal products, and whether they are mild or serious. Intensity of the adverse events were defined as Mild: Adverse event that is easily tolerated. Moderate: AEs causing discomfort sufficient for impairment of everyday activity. Severe: Adverse event preventing normal everyday activity
|
2.0%
1/49 • Number of events 1 • Through study completion, approximately 7 months.
An AE is any unfavourable sign (including abnormal lab results), symptom, or disease that are time-associated with vaccine use, regardless whether or not they are viewed as having been caused by medicinal products, and whether they are mild or serious. Intensity of the adverse events were defined as Mild: Adverse event that is easily tolerated. Moderate: AEs causing discomfort sufficient for impairment of everyday activity. Severe: Adverse event preventing normal everyday activity
|
|
Hepatobiliary disorders
steatohepatitis
|
0.00%
0/50 • Through study completion, approximately 7 months.
An AE is any unfavourable sign (including abnormal lab results), symptom, or disease that are time-associated with vaccine use, regardless whether or not they are viewed as having been caused by medicinal products, and whether they are mild or serious. Intensity of the adverse events were defined as Mild: Adverse event that is easily tolerated. Moderate: AEs causing discomfort sufficient for impairment of everyday activity. Severe: Adverse event preventing normal everyday activity
|
2.0%
1/49 • Number of events 1 • Through study completion, approximately 7 months.
An AE is any unfavourable sign (including abnormal lab results), symptom, or disease that are time-associated with vaccine use, regardless whether or not they are viewed as having been caused by medicinal products, and whether they are mild or serious. Intensity of the adverse events were defined as Mild: Adverse event that is easily tolerated. Moderate: AEs causing discomfort sufficient for impairment of everyday activity. Severe: Adverse event preventing normal everyday activity
|
|
Musculoskeletal and connective tissue disorders
weakness
|
0.00%
0/50 • Through study completion, approximately 7 months.
An AE is any unfavourable sign (including abnormal lab results), symptom, or disease that are time-associated with vaccine use, regardless whether or not they are viewed as having been caused by medicinal products, and whether they are mild or serious. Intensity of the adverse events were defined as Mild: Adverse event that is easily tolerated. Moderate: AEs causing discomfort sufficient for impairment of everyday activity. Severe: Adverse event preventing normal everyday activity
|
2.0%
1/49 • Number of events 1 • Through study completion, approximately 7 months.
An AE is any unfavourable sign (including abnormal lab results), symptom, or disease that are time-associated with vaccine use, regardless whether or not they are viewed as having been caused by medicinal products, and whether they are mild or serious. Intensity of the adverse events were defined as Mild: Adverse event that is easily tolerated. Moderate: AEs causing discomfort sufficient for impairment of everyday activity. Severe: Adverse event preventing normal everyday activity
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place