Trial Outcomes & Findings for A Study to Compare the Pharmacokinetics (PK) of Depemokimab When Delivered With a Safety Syringe Device (SSD) or an Autoinjector in Healthy Adult Participants (NCT NCT05602025)
NCT ID: NCT05602025
Last Updated: 2026-06-16
Results Overview
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of depemokimab. PK analysis was conducted using standard non-compartmental methods.
COMPLETED
PHASE1
140 participants
Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
2026-06-16
Participant Flow
This was a single-dose study in healthy adult participants to compare the pharmacokinetics of depemokimab when delivered with a Safety Syringe Device (SSD) or an Autoinjector.
A total of 140 participants were enrolled in the study.
Participant milestones
| Measure |
Depemokimab Via SSD
Participants received a single subcutaneous dose of 100 milligrams (mg) of depemokimab administered via a Safety Syringe Device (SSD) on Day 1.
|
Depemokimab Via Autoinjector
Participants received a single subcutaneous dose of 100 mg of depemokimab administered via an autoinjector on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
70
|
|
Overall Study
COMPLETED
|
69
|
69
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Depemokimab Via SSD
Participants received a single subcutaneous dose of 100 milligrams (mg) of depemokimab administered via a Safety Syringe Device (SSD) on Day 1.
|
Depemokimab Via Autoinjector
Participants received a single subcutaneous dose of 100 mg of depemokimab administered via an autoinjector on Day 1.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
A Study to Compare the Pharmacokinetics (PK) of Depemokimab When Delivered With a Safety Syringe Device (SSD) or an Autoinjector in Healthy Adult Participants
Baseline characteristics by cohort
| Measure |
Depemokimab Via SSD
n=70 Participants
Participants received a single subcutaneous dose of 100 milligrams (mg) of depemokimab administered via a Safety Syringe Device (SSD) on Day 1.
|
Depemokimab Via Autoinjector
n=70 Participants
Participants received a single subcutaneous dose of 100 mg of depemokimab administered via an autoinjector on Day 1.
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.2 YEARS
STANDARD_DEVIATION 7.76 • n=20 Participants
|
34.8 YEARS
STANDARD_DEVIATION 8.25 • n=20 Participants
|
35.5 YEARS
STANDARD_DEVIATION 8.01 • n=40 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=20 Participants
|
40 Participants
n=20 Participants
|
75 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=20 Participants
|
30 Participants
n=20 Participants
|
65 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
15 Participants
n=20 Participants
|
22 Participants
n=20 Participants
|
37 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White
|
45 Participants
n=20 Participants
|
43 Participants
n=20 Participants
|
88 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
6 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dosePopulation: Pharmacokinetic Population consisted of all participants in the Safety analysis set for whom at least one evaluable pharmacokinetic sample was obtained and analyzed.
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of depemokimab. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Depemokimab Via SSD
n=70 Participants
Participants received a single subcutaneous dose of 100 milligrams (mg) of depemokimab administered via a Safety Syringe Device (SSD) on Day 1.
|
Depemokimab Via Autoinjector
n=70 Participants
Participants received a single subcutaneous dose of 100 mg of depemokimab administered via an autoinjector on Day 1.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Depemokimab
|
14.68 Micrograms per milliliter
Geometric Coefficient of Variation 24.17
|
14.97 Micrograms per milliliter
Geometric Coefficient of Variation 23.29
|
PRIMARY outcome
Timeframe: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dosePopulation: Pharmacokinetic Population consisted of all participants in the Safety analysis set for whom at least one evaluable pharmacokinetic sample was obtained and analyzed. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the 'Overall Number of Participants Analyzed' field.
Blood samples were collected at indicated time points for PK analysis of depemokimab. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Depemokimab Via SSD
n=70 Participants
Participants received a single subcutaneous dose of 100 milligrams (mg) of depemokimab administered via a Safety Syringe Device (SSD) on Day 1.
|
Depemokimab Via Autoinjector
n=69 Participants
Participants received a single subcutaneous dose of 100 mg of depemokimab administered via an autoinjector on Day 1.
|
|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0-inf]) of Depemokimab
|
1061.05 Day*microgram/mL
Geometric Coefficient of Variation 26.89
|
1078.66 Day*microgram/mL
Geometric Coefficient of Variation 28.39
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dosePopulation: Pharmacokinetic Population consisted of all participants in the Safety analysis set for whom at least one evaluable pharmacokinetic sample was obtained and analyzed.
Blood samples were collected at indicated time points for PK analysis of depemokimab. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Depemokimab Via SSD
n=70 Participants
Participants received a single subcutaneous dose of 100 milligrams (mg) of depemokimab administered via a Safety Syringe Device (SSD) on Day 1.
|
Depemokimab Via Autoinjector
n=70 Participants
Participants received a single subcutaneous dose of 100 mg of depemokimab administered via an autoinjector on Day 1.
|
|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to Time of Last Observed Quantifiable Concentration (AUC[0-t]) of Depemokimab
|
999.38 Day*microgram/mL
Geometric Coefficient of Variation 26.07
|
1014.29 Day*microgram/mL
Geometric Coefficient of Variation 27.35
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dosePopulation: Pharmacokinetic Population consisted of all participants in the Safety analysis set for whom at least one evaluable pharmacokinetic sample was obtained and analyzed.
Blood samples were collected at indicated time points for PK analysis of depemokimab. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Depemokimab Via SSD
n=70 Participants
Participants received a single subcutaneous dose of 100 milligrams (mg) of depemokimab administered via a Safety Syringe Device (SSD) on Day 1.
|
Depemokimab Via Autoinjector
n=70 Participants
Participants received a single subcutaneous dose of 100 mg of depemokimab administered via an autoinjector on Day 1.
|
|---|---|---|
|
Time to Maximum Observed Plasma Concentration (Tmax) of Depemokimab
|
12.97 Day
Interval 4.0 to 28.9
|
12.43 Day
Interval 3.9 to 28.0
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dosePopulation: Pharmacokinetic Population consisted of all participants in the Safety analysis set for whom at least one evaluable pharmacokinetic sample was obtained and analyzed. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the 'Overall Number of Participants Analyzed' field.
Blood samples were collected at indicated time points for PK analysis of depemokimab. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Depemokimab Via SSD
n=70 Participants
Participants received a single subcutaneous dose of 100 milligrams (mg) of depemokimab administered via a Safety Syringe Device (SSD) on Day 1.
|
Depemokimab Via Autoinjector
n=69 Participants
Participants received a single subcutaneous dose of 100 mg of depemokimab administered via an autoinjector on Day 1.
|
|---|---|---|
|
Apparent Clearance Following Extravascular Administration (CL/F) of Depemokimab
|
0.09 Liters/day
Geometric Coefficient of Variation 26.89
|
0.09 Liters/day
Geometric Coefficient of Variation 28.39
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dosePopulation: Pharmacokinetic Population consisted of all participants in the Safety analysis set for whom at least one evaluable pharmacokinetic sample was obtained and analyzed. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the 'Overall Number of Participants Analyzed' field.
Blood samples were collected at indicated time points for PK analysis of depemokimab. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Depemokimab Via SSD
n=70 Participants
Participants received a single subcutaneous dose of 100 milligrams (mg) of depemokimab administered via a Safety Syringe Device (SSD) on Day 1.
|
Depemokimab Via Autoinjector
n=69 Participants
Participants received a single subcutaneous dose of 100 mg of depemokimab administered via an autoinjector on Day 1.
|
|---|---|---|
|
Apparent Volume of Distribution Following Extravascular Administration (Vd/F) of Depemokimab
|
5.64 Liters
Geometric Coefficient of Variation 25.02
|
5.51 Liters
Geometric Coefficient of Variation 27.23
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dosePopulation: Pharmacokinetic Population consisted of all participants in the Safety analysis set for whom at least one evaluable pharmacokinetic sample was obtained and analyzed. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the 'Overall Number of Participants Analyzed' field.
Blood samples were collected at indicated time points for PK analysis of depemokimab. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Depemokimab Via SSD
n=70 Participants
Participants received a single subcutaneous dose of 100 milligrams (mg) of depemokimab administered via a Safety Syringe Device (SSD) on Day 1.
|
Depemokimab Via Autoinjector
n=69 Participants
Participants received a single subcutaneous dose of 100 mg of depemokimab administered via an autoinjector on Day 1.
|
|---|---|---|
|
Terminal Elimination Rate Constant (Lambda z) of Depemokimab
|
0.02 Per day
Geometric Coefficient of Variation 24.46
|
0.02 Per day
Geometric Coefficient of Variation 23.49
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dosePopulation: Pharmacokinetic Population consisted of all participants in the Safety analysis set for whom at least one evaluable pharmacokinetic sample was obtained and analyzed. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the 'Overall Number of Participants Analyzed' field.
Blood samples were collected at indicated time points for PK analysis of depemokimab. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Depemokimab Via SSD
n=70 Participants
Participants received a single subcutaneous dose of 100 milligrams (mg) of depemokimab administered via a Safety Syringe Device (SSD) on Day 1.
|
Depemokimab Via Autoinjector
n=69 Participants
Participants received a single subcutaneous dose of 100 mg of depemokimab administered via an autoinjector on Day 1.
|
|---|---|---|
|
Terminal Elimination Half-Life (T1/2) Following Administration of Depemokimab
|
41.45 Day
Geometric Coefficient of Variation 24.46
|
41.19 Day
Geometric Coefficient of Variation 23.49
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dosePopulation: Pharmacokinetic Population consisted of all participants in the Safety analysis set for whom at least one evaluable pharmacokinetic sample was obtained and analyzed.
Blood samples were collected at indicated time points for PK analysis of depemokimab. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Depemokimab Via SSD
n=70 Participants
Participants received a single subcutaneous dose of 100 milligrams (mg) of depemokimab administered via a Safety Syringe Device (SSD) on Day 1.
|
Depemokimab Via Autoinjector
n=70 Participants
Participants received a single subcutaneous dose of 100 mg of depemokimab administered via an autoinjector on Day 1.
|
|---|---|---|
|
Time of Last Measurable Plasma Concentrations (Tlast) of Depemokimab
|
179.21 Day
Standard Deviation 13.510
|
177.74 Day
Standard Deviation 16.385
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dosePopulation: Pharmacokinetic Population consisted of all participants in the Safety analysis set for whom at least one evaluable pharmacokinetic sample was obtained and analyzed. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the 'Overall Number of Participants Analyzed' field.
Blood samples were collected at indicated time points for PK analysis of depemokimab. PK analysis was conducted using standard non-compartmental methods. The percentage of AUC (0-inf) obtained by extrapolation (%AUCex) was calculated as: (AUC\[0-inf\] - AUC\[0-t\]) /AUC(0-inf)\*100.
Outcome measures
| Measure |
Depemokimab Via SSD
n=70 Participants
Participants received a single subcutaneous dose of 100 milligrams (mg) of depemokimab administered via a Safety Syringe Device (SSD) on Day 1.
|
Depemokimab Via Autoinjector
n=69 Participants
Participants received a single subcutaneous dose of 100 mg of depemokimab administered via an autoinjector on Day 1.
|
|---|---|---|
|
Percentage of AUC (0-Inf) Due to Extrapolation From the Time of the Last Observed Concentration (Tlast) to Infinity (%AUCex) of Depemokimab
|
5.02 Percentage of AUC extrapolation
Geometric Coefficient of Variation 73.24
|
5.06 Percentage of AUC extrapolation
Geometric Coefficient of Variation 64.04
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Weeks 4, 8, 12 and 26Population: Safety Population included all participants who received at least 1 dose of study intervention. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for specified time points.
Blood samples were collected and analyzed for the presence of anti- depemokimab antibodies using a validated immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Depemokimab Via SSD
n=70 Participants
Participants received a single subcutaneous dose of 100 milligrams (mg) of depemokimab administered via a Safety Syringe Device (SSD) on Day 1.
|
Depemokimab Via Autoinjector
n=70 Participants
Participants received a single subcutaneous dose of 100 mg of depemokimab administered via an autoinjector on Day 1.
|
|---|---|---|
|
Number of Participants With Presence of Positive Anti-depemokimab Antibodies
Week 12
|
1 Participants
|
0 Participants
|
|
Number of Participants With Presence of Positive Anti-depemokimab Antibodies
Baseline (Day 1)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Presence of Positive Anti-depemokimab Antibodies
Week 4
|
1 Participants
|
0 Participants
|
|
Number of Participants With Presence of Positive Anti-depemokimab Antibodies
Week 8
|
1 Participants
|
0 Participants
|
|
Number of Participants With Presence of Positive Anti-depemokimab Antibodies
Week 26
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Weeks 4, 8, 12 and 26Population: Safety Population included all participants who received at least 1 dose of study intervention. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for specified time points.
Blood samples were collected for determination of positive neutralizing antibodies. A neutralizing antibody assay was performed. Neutralizing antibody test was only carried out for participants who have had a positive confirmatory binding antibody test result at visit. A participant was considered positive if they had at least one positive post-Baseline neutralizing antibody result. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Depemokimab Via SSD
n=2 Participants
Participants received a single subcutaneous dose of 100 milligrams (mg) of depemokimab administered via a Safety Syringe Device (SSD) on Day 1.
|
Depemokimab Via Autoinjector
n=1 Participants
Participants received a single subcutaneous dose of 100 mg of depemokimab administered via an autoinjector on Day 1.
|
|---|---|---|
|
Number of Participants With Positive Neutralizing Antibodies to Depemokimab
Baseline (Day 1)
|
1 Participants
|
—
|
|
Number of Participants With Positive Neutralizing Antibodies to Depemokimab
Week 4
|
1 Participants
|
—
|
|
Number of Participants With Positive Neutralizing Antibodies to Depemokimab
Week 8
|
1 Participants
|
—
|
|
Number of Participants With Positive Neutralizing Antibodies to Depemokimab
Week 12
|
1 Participants
|
—
|
|
Number of Participants With Positive Neutralizing Antibodies to Depemokimab
Week 26
|
1 Participants
|
1 Participants
|
Adverse Events
Depemokimab Via SSD
Depemokimab Via Autoinjector
Serious adverse events
| Measure |
Depemokimab Via SSD
n=70 participants at risk
Participants received a single subcutaneous dose of 100 milligrams (mg) of depemokimab administered via a Safety Syringe Device (SSD) on Day 1.
|
Depemokimab Via Autoinjector
n=70 participants at risk
Participants received a single subcutaneous dose of 100 mg of depemokimab administered via an autoinjector on Day 1.
|
|---|---|---|
|
Infections and infestations
Pelvic inflammatory disease
|
0.00%
0/70 • All-cause mortality, serious adverse events (SAEs) and common greater than equal to (>=) 3 percent (%) non-serious adverse events (Non-SAEs) were collected up to 211 days
All-cause mortality, SAEs and common (\>=3%) non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study intervention.
|
1.4%
1/70 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common greater than equal to (>=) 3 percent (%) non-serious adverse events (Non-SAEs) were collected up to 211 days
All-cause mortality, SAEs and common (\>=3%) non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study intervention.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/70 • All-cause mortality, serious adverse events (SAEs) and common greater than equal to (>=) 3 percent (%) non-serious adverse events (Non-SAEs) were collected up to 211 days
All-cause mortality, SAEs and common (\>=3%) non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study intervention.
|
1.4%
1/70 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and common greater than equal to (>=) 3 percent (%) non-serious adverse events (Non-SAEs) were collected up to 211 days
All-cause mortality, SAEs and common (\>=3%) non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study intervention.
|
Other adverse events
| Measure |
Depemokimab Via SSD
n=70 participants at risk
Participants received a single subcutaneous dose of 100 milligrams (mg) of depemokimab administered via a Safety Syringe Device (SSD) on Day 1.
|
Depemokimab Via Autoinjector
n=70 participants at risk
Participants received a single subcutaneous dose of 100 mg of depemokimab administered via an autoinjector on Day 1.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
1/70 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common greater than equal to (>=) 3 percent (%) non-serious adverse events (Non-SAEs) were collected up to 211 days
All-cause mortality, SAEs and common (\>=3%) non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study intervention.
|
4.3%
3/70 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and common greater than equal to (>=) 3 percent (%) non-serious adverse events (Non-SAEs) were collected up to 211 days
All-cause mortality, SAEs and common (\>=3%) non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
1/70 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common greater than equal to (>=) 3 percent (%) non-serious adverse events (Non-SAEs) were collected up to 211 days
All-cause mortality, SAEs and common (\>=3%) non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study intervention.
|
4.3%
3/70 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and common greater than equal to (>=) 3 percent (%) non-serious adverse events (Non-SAEs) were collected up to 211 days
All-cause mortality, SAEs and common (\>=3%) non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Nausea
|
4.3%
3/70 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and common greater than equal to (>=) 3 percent (%) non-serious adverse events (Non-SAEs) were collected up to 211 days
All-cause mortality, SAEs and common (\>=3%) non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study intervention.
|
1.4%
1/70 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common greater than equal to (>=) 3 percent (%) non-serious adverse events (Non-SAEs) were collected up to 211 days
All-cause mortality, SAEs and common (\>=3%) non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
3/70 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and common greater than equal to (>=) 3 percent (%) non-serious adverse events (Non-SAEs) were collected up to 211 days
All-cause mortality, SAEs and common (\>=3%) non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study intervention.
|
1.4%
1/70 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common greater than equal to (>=) 3 percent (%) non-serious adverse events (Non-SAEs) were collected up to 211 days
All-cause mortality, SAEs and common (\>=3%) non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study intervention.
|
|
General disorders
Injection site bruising
|
4.3%
3/70 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and common greater than equal to (>=) 3 percent (%) non-serious adverse events (Non-SAEs) were collected up to 211 days
All-cause mortality, SAEs and common (\>=3%) non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study intervention.
|
1.4%
1/70 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common greater than equal to (>=) 3 percent (%) non-serious adverse events (Non-SAEs) were collected up to 211 days
All-cause mortality, SAEs and common (\>=3%) non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study intervention.
|
|
General disorders
Injection site erythema
|
2.9%
2/70 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and common greater than equal to (>=) 3 percent (%) non-serious adverse events (Non-SAEs) were collected up to 211 days
All-cause mortality, SAEs and common (\>=3%) non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study intervention.
|
4.3%
3/70 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and common greater than equal to (>=) 3 percent (%) non-serious adverse events (Non-SAEs) were collected up to 211 days
All-cause mortality, SAEs and common (\>=3%) non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study intervention.
|
|
General disorders
Injection site swelling
|
1.4%
1/70 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and common greater than equal to (>=) 3 percent (%) non-serious adverse events (Non-SAEs) were collected up to 211 days
All-cause mortality, SAEs and common (\>=3%) non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study intervention.
|
5.7%
4/70 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and common greater than equal to (>=) 3 percent (%) non-serious adverse events (Non-SAEs) were collected up to 211 days
All-cause mortality, SAEs and common (\>=3%) non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
COVID-19
|
2.9%
2/70 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and common greater than equal to (>=) 3 percent (%) non-serious adverse events (Non-SAEs) were collected up to 211 days
All-cause mortality, SAEs and common (\>=3%) non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study intervention.
|
4.3%
3/70 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and common greater than equal to (>=) 3 percent (%) non-serious adverse events (Non-SAEs) were collected up to 211 days
All-cause mortality, SAEs and common (\>=3%) non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/70 • All-cause mortality, serious adverse events (SAEs) and common greater than equal to (>=) 3 percent (%) non-serious adverse events (Non-SAEs) were collected up to 211 days
All-cause mortality, SAEs and common (\>=3%) non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study intervention.
|
4.3%
3/70 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and common greater than equal to (>=) 3 percent (%) non-serious adverse events (Non-SAEs) were collected up to 211 days
All-cause mortality, SAEs and common (\>=3%) non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Headache
|
10.0%
7/70 • Number of events 8 • All-cause mortality, serious adverse events (SAEs) and common greater than equal to (>=) 3 percent (%) non-serious adverse events (Non-SAEs) were collected up to 211 days
All-cause mortality, SAEs and common (\>=3%) non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study intervention.
|
8.6%
6/70 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and common greater than equal to (>=) 3 percent (%) non-serious adverse events (Non-SAEs) were collected up to 211 days
All-cause mortality, SAEs and common (\>=3%) non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study intervention.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/70 • All-cause mortality, serious adverse events (SAEs) and common greater than equal to (>=) 3 percent (%) non-serious adverse events (Non-SAEs) were collected up to 211 days
All-cause mortality, SAEs and common (\>=3%) non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study intervention.
|
4.3%
3/70 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and common greater than equal to (>=) 3 percent (%) non-serious adverse events (Non-SAEs) were collected up to 211 days
All-cause mortality, SAEs and common (\>=3%) non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study intervention.
|
Additional Information
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