Trial Outcomes & Findings for Pharmacokinetic Study of Cabotegravir and Rilpivirine Long-acting Intramuscular Injections in Healthy Adult Participants (NCT NCT04371380)
NCT ID: NCT04371380
Last Updated: 2024-04-22
Results Overview
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of CAB.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
Day 1 (pre-dose, 1 hour, 2 hours) and one post-dose sample on day 2, day 4, day 5, day 8, day 10, day 15, day 17, day 22, day 28, week 8, week 12, week 24, week 36 and week 52
Results posted on
2024-04-22
Participant Flow
Fifteen participants were enrolled in the study. All the 15 participants received treatment in Oral Lead-in Phase. 14 out of 15 participants received treatment in Injection Phase. All the 14 participants in Injection phase completed the follow up phase.
Participant milestones
| Measure |
Oral lead-in Phase - Cabotegravir (CAB) 30 Microgram (mg) + Rilpivirine (RPV) 25mg
Participants received 30 mg of CAB tablets orally along with 25 mg of RPV tablets once daily with meal from day 1 to day 28 of oral lead-in (OLI) phase.
|
Injection Phase - CAB 600mg + RPV 900mg
Participants received single intramuscular (IM) dose of 600 mg of CAB LA injection on left and 900 mg of RPV LA injection on right side of lateral thigh on day 1 of injection phase (IP).
|
Follow-up Phase - CAB 600mg + RPV 900mg
Participant who received 600 mg of CAB LA 900 mg of RPV LA injection during injection phase returned for safety assessments and additional PK sampling post injection in follow-up phase.
|
|---|---|---|---|
|
Oral Lead-in Phase (Up to Day 28)
STARTED
|
15
|
0
|
0
|
|
Oral Lead-in Phase (Up to Day 28)
COMPLETED
|
14
|
0
|
0
|
|
Oral Lead-in Phase (Up to Day 28)
NOT COMPLETED
|
1
|
0
|
0
|
|
Injection Phase (IP)-Day 1[IP] to Week 4
STARTED
|
0
|
14
|
0
|
|
Injection Phase (IP)-Day 1[IP] to Week 4
COMPLETED
|
0
|
14
|
0
|
|
Injection Phase (IP)-Day 1[IP] to Week 4
NOT COMPLETED
|
0
|
0
|
0
|
|
Follow-up Phase (Week 4 to Week 52)
STARTED
|
0
|
0
|
14
|
|
Follow-up Phase (Week 4 to Week 52)
COMPLETED
|
0
|
0
|
14
|
|
Follow-up Phase (Week 4 to Week 52)
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Oral lead-in Phase - Cabotegravir (CAB) 30 Microgram (mg) + Rilpivirine (RPV) 25mg
Participants received 30 mg of CAB tablets orally along with 25 mg of RPV tablets once daily with meal from day 1 to day 28 of oral lead-in (OLI) phase.
|
Injection Phase - CAB 600mg + RPV 900mg
Participants received single intramuscular (IM) dose of 600 mg of CAB LA injection on left and 900 mg of RPV LA injection on right side of lateral thigh on day 1 of injection phase (IP).
|
Follow-up Phase - CAB 600mg + RPV 900mg
Participant who received 600 mg of CAB LA 900 mg of RPV LA injection during injection phase returned for safety assessments and additional PK sampling post injection in follow-up phase.
|
|---|---|---|---|
|
Oral Lead-in Phase (Up to Day 28)
Physician Decision
|
1
|
0
|
0
|
Baseline Characteristics
Pharmacokinetic Study of Cabotegravir and Rilpivirine Long-acting Intramuscular Injections in Healthy Adult Participants
Baseline characteristics by cohort
| Measure |
All Enrolled Participants
n=15 Participants
Participants who signed the informed consent form and received at least 1 dose of study drug.
|
|---|---|
|
Age, Continuous
|
34.3 YEARS
STANDARD_DEVIATION 7.72 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose, 1 hour, 2 hours) and one post-dose sample on day 2, day 4, day 5, day 8, day 10, day 15, day 17, day 22, day 28, week 8, week 12, week 24, week 36 and week 52Population: Pharmacokinetic (PK) parameter population included all participants who underwent plasma PK sampling and have evaluable PK parameters estimated.
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of CAB.
Outcome measures
| Measure |
IM CAB 600 mg
n=13 Participants
Participants received single IM dose of 600 mg of CAB LA injection on left side of lateral thigh on day 1 of injection phase.
|
Injection Phase - CAB 600mg + RPV 900mg
Participants received single intramuscular (IM) dose of 600 mg of CAB LA injection on left and 900 mg of RPV LA injection on right side of lateral thigh on day 1 of injection phase (IP).
|
Follow-up Phase - CAB 600mg + RPV 900mg
Participant who received 600 mg of CAB LA 900 mg of RPV LA injection during injection phase returned for safety assessments and additional PK sampling post injection in follow-up phase.
|
|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of Cabotegravir (CAB) Following Single IM Injection
|
3.38 Microgram per milliliter (ug/mL)
Geometric Coefficient of Variation 66
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose, 1 hour, 2 hours) and one post-dose sample on day 2, day 4, day 5, day 8, day 10, day 15, day 17, day 22, day 28, week 8, week 12, week 24, week 36 and week 52Population: PK parameter population
Blood samples were collected at indicated time points for PK analysis of RPV.
Outcome measures
| Measure |
IM CAB 600 mg
n=14 Participants
Participants received single IM dose of 600 mg of CAB LA injection on left side of lateral thigh on day 1 of injection phase.
|
Injection Phase - CAB 600mg + RPV 900mg
Participants received single intramuscular (IM) dose of 600 mg of CAB LA injection on left and 900 mg of RPV LA injection on right side of lateral thigh on day 1 of injection phase (IP).
|
Follow-up Phase - CAB 600mg + RPV 900mg
Participant who received 600 mg of CAB LA 900 mg of RPV LA injection during injection phase returned for safety assessments and additional PK sampling post injection in follow-up phase.
|
|---|---|---|---|
|
Cmax of Rilpivirine (RPV) Following Single IM Injection
|
93.5 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 37.7
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose, 1 hour, 2 hours) and one post-dose sample on day 2, day 4, day 5, day 8, day 10, day 15, day 17, day 22, day 28, week 8, week 12, week 24, week 36 and week 52Population: PK parameter population
Blood samples were collected at indicated time points for PK analysis of CAB.
Outcome measures
| Measure |
IM CAB 600 mg
n=13 Participants
Participants received single IM dose of 600 mg of CAB LA injection on left side of lateral thigh on day 1 of injection phase.
|
Injection Phase - CAB 600mg + RPV 900mg
Participants received single intramuscular (IM) dose of 600 mg of CAB LA injection on left and 900 mg of RPV LA injection on right side of lateral thigh on day 1 of injection phase (IP).
|
Follow-up Phase - CAB 600mg + RPV 900mg
Participant who received 600 mg of CAB LA 900 mg of RPV LA injection during injection phase returned for safety assessments and additional PK sampling post injection in follow-up phase.
|
|---|---|---|---|
|
Time of Cmax (Tmax) of CAB Following Single IM Injection
|
167 Hour
Interval 166.0 to 1317.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose, 1 hour, 2 hours) and one post-dose sample on day 2, day 4, day 5, day 8, day 10, day 15, day 17, day 22, day 28, week 8, week 12, week 24, week 36 and week 52Population: PK parameter population
Blood samples were collected at indicated time points for PK analysis of RPV.
Outcome measures
| Measure |
IM CAB 600 mg
n=14 Participants
Participants received single IM dose of 600 mg of CAB LA injection on left side of lateral thigh on day 1 of injection phase.
|
Injection Phase - CAB 600mg + RPV 900mg
Participants received single intramuscular (IM) dose of 600 mg of CAB LA injection on left and 900 mg of RPV LA injection on right side of lateral thigh on day 1 of injection phase (IP).
|
Follow-up Phase - CAB 600mg + RPV 900mg
Participant who received 600 mg of CAB LA 900 mg of RPV LA injection during injection phase returned for safety assessments and additional PK sampling post injection in follow-up phase.
|
|---|---|---|---|
|
Tmax of RPV Following Single IM Injection
|
131 Hour
Interval 70.1 to 647.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose, 1 hour, 2 hours) and one post-dose sample on day 2, day 4, day 5, day 8, day 10, day 15, day 17, day 22, day 28, week 8, week 12, week 24, week 36 and week 52Population: PK parameter population
Blood samples were collected at indicated time points for PK analysis of CAB.
Outcome measures
| Measure |
IM CAB 600 mg
n=13 Participants
Participants received single IM dose of 600 mg of CAB LA injection on left side of lateral thigh on day 1 of injection phase.
|
Injection Phase - CAB 600mg + RPV 900mg
Participants received single intramuscular (IM) dose of 600 mg of CAB LA injection on left and 900 mg of RPV LA injection on right side of lateral thigh on day 1 of injection phase (IP).
|
Follow-up Phase - CAB 600mg + RPV 900mg
Participant who received 600 mg of CAB LA 900 mg of RPV LA injection during injection phase returned for safety assessments and additional PK sampling post injection in follow-up phase.
|
|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Time (AUC[0-t]) of CAB Following Single IM Injection
|
3612 Hour*microgram per milliliter (h*ug/mL)
Geometric Coefficient of Variation 23
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose, 1 hour, 2 hours) and one post-dose sample on day 2, day 4, day 5, day 8, day 10, day 15, day 17, day 22, day 28, week 8, week 12, week 24, week 36 and week 52Population: PK parameter population
Blood samples were collected at indicated time points for PK analysis of RPV.
Outcome measures
| Measure |
IM CAB 600 mg
n=14 Participants
Participants received single IM dose of 600 mg of CAB LA injection on left side of lateral thigh on day 1 of injection phase.
|
Injection Phase - CAB 600mg + RPV 900mg
Participants received single intramuscular (IM) dose of 600 mg of CAB LA injection on left and 900 mg of RPV LA injection on right side of lateral thigh on day 1 of injection phase (IP).
|
Follow-up Phase - CAB 600mg + RPV 900mg
Participant who received 600 mg of CAB LA 900 mg of RPV LA injection during injection phase returned for safety assessments and additional PK sampling post injection in follow-up phase.
|
|---|---|---|---|
|
AUC(0-t) of RPV Following Single IM Injection
|
143891 h*ng/mL
Geometric Coefficient of Variation 33
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose, 1 hour, 2 hours) and one post-dose sample on day 2, day 4, day 5, day 8, day 10, day 15, day 17, day 22, day 28, week 8, week 12, week 24, week 36 and week 52Population: PK parameter population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points for PK analysis of CAB.
Outcome measures
| Measure |
IM CAB 600 mg
n=10 Participants
Participants received single IM dose of 600 mg of CAB LA injection on left side of lateral thigh on day 1 of injection phase.
|
Injection Phase - CAB 600mg + RPV 900mg
Participants received single intramuscular (IM) dose of 600 mg of CAB LA injection on left and 900 mg of RPV LA injection on right side of lateral thigh on day 1 of injection phase (IP).
|
Follow-up Phase - CAB 600mg + RPV 900mg
Participant who received 600 mg of CAB LA 900 mg of RPV LA injection during injection phase returned for safety assessments and additional PK sampling post injection in follow-up phase.
|
|---|---|---|---|
|
AUC From Time Zero Extrapolated to Infinity (AUC[0-infinity]) of CAB Following Single IM Injection
|
3948 h*ug/mL
Geometric Coefficient of Variation 21.5
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose, 1 hour, 2 hours) and one post-dose sample on day 2, day 4, day 5, day 8, day 10, day 15, day 17, day 22, day 28, week 8, week 12, week 24, week 36 and week 52Population: PK parameter population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points for PK analysis of RPV.
Outcome measures
| Measure |
IM CAB 600 mg
n=11 Participants
Participants received single IM dose of 600 mg of CAB LA injection on left side of lateral thigh on day 1 of injection phase.
|
Injection Phase - CAB 600mg + RPV 900mg
Participants received single intramuscular (IM) dose of 600 mg of CAB LA injection on left and 900 mg of RPV LA injection on right side of lateral thigh on day 1 of injection phase (IP).
|
Follow-up Phase - CAB 600mg + RPV 900mg
Participant who received 600 mg of CAB LA 900 mg of RPV LA injection during injection phase returned for safety assessments and additional PK sampling post injection in follow-up phase.
|
|---|---|---|---|
|
AUC(0-infinity) of RPV Following Single IM Injection
|
171953 h*ng/mL
Geometric Coefficient of Variation 31.1
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose, 1 hour, 2 hours) and one post-dose sample on day 2, day 4, day 5, day 8, day 10, day 15, day 17, day 22, day 28, week 8, week 12, week 24, week 36 and week 52Population: PK parameter population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points for PK analysis of CAB.
Outcome measures
| Measure |
IM CAB 600 mg
n=10 Participants
Participants received single IM dose of 600 mg of CAB LA injection on left side of lateral thigh on day 1 of injection phase.
|
Injection Phase - CAB 600mg + RPV 900mg
Participants received single intramuscular (IM) dose of 600 mg of CAB LA injection on left and 900 mg of RPV LA injection on right side of lateral thigh on day 1 of injection phase (IP).
|
Follow-up Phase - CAB 600mg + RPV 900mg
Participant who received 600 mg of CAB LA 900 mg of RPV LA injection during injection phase returned for safety assessments and additional PK sampling post injection in follow-up phase.
|
|---|---|---|---|
|
Apparent Terminal Phase Half-life (t1/2) of CAB Following Single IM Injection
|
21.4 Days
Geometric Coefficient of Variation 79.3
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose, 1 hour, 2 hours) and one post-dose sample on day 2, day 4, day 5, day 8, day 10, day 15, day 17, day 22, day 28, week 8, week 12, week 24, week 36 and week 52Population: PK parameter population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points for PK analysis of RPV.
Outcome measures
| Measure |
IM CAB 600 mg
n=11 Participants
Participants received single IM dose of 600 mg of CAB LA injection on left side of lateral thigh on day 1 of injection phase.
|
Injection Phase - CAB 600mg + RPV 900mg
Participants received single intramuscular (IM) dose of 600 mg of CAB LA injection on left and 900 mg of RPV LA injection on right side of lateral thigh on day 1 of injection phase (IP).
|
Follow-up Phase - CAB 600mg + RPV 900mg
Participant who received 600 mg of CAB LA 900 mg of RPV LA injection during injection phase returned for safety assessments and additional PK sampling post injection in follow-up phase.
|
|---|---|---|---|
|
t1/2 of RPV Following Single IM Injection
|
137 Days
Geometric Coefficient of Variation 26.6
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose, 1 hour, 2 hours) and one post-dose sample on day 2, day 4, day 5, day 8, day 10, day 15, day 17, day 22, day 28, week 8, week 12, week 24, week 36 and week 52Population: PK parameter population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points for PK analysis of CAB.
Outcome measures
| Measure |
IM CAB 600 mg
n=10 Participants
Participants received single IM dose of 600 mg of CAB LA injection on left side of lateral thigh on day 1 of injection phase.
|
Injection Phase - CAB 600mg + RPV 900mg
Participants received single intramuscular (IM) dose of 600 mg of CAB LA injection on left and 900 mg of RPV LA injection on right side of lateral thigh on day 1 of injection phase (IP).
|
Follow-up Phase - CAB 600mg + RPV 900mg
Participant who received 600 mg of CAB LA 900 mg of RPV LA injection during injection phase returned for safety assessments and additional PK sampling post injection in follow-up phase.
|
|---|---|---|---|
|
Geometric Mean of Absorption Rate Constant (KALA) of CAB Following Single IM Injection
|
0.00135 Per hour (/h)
Geometric Coefficient of Variation 79.3
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose, 1 hour, 2 hours) and one post-dose sample on day 2, day 4, day 5, day 8, day 10, day 15, day 17, day 22, day 28, week 8, week 12, week 24, week 36 and week 52Population: PK parameter population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points for PK analysis of RPV.
Outcome measures
| Measure |
IM CAB 600 mg
n=11 Participants
Participants received single IM dose of 600 mg of CAB LA injection on left side of lateral thigh on day 1 of injection phase.
|
Injection Phase - CAB 600mg + RPV 900mg
Participants received single intramuscular (IM) dose of 600 mg of CAB LA injection on left and 900 mg of RPV LA injection on right side of lateral thigh on day 1 of injection phase (IP).
|
Follow-up Phase - CAB 600mg + RPV 900mg
Participant who received 600 mg of CAB LA 900 mg of RPV LA injection during injection phase returned for safety assessments and additional PK sampling post injection in follow-up phase.
|
|---|---|---|---|
|
Geometric Mean of Absorption Rate Constant (KALA) of RPV Following Single IM Injection
|
0.000211 Per hour (/h)
Geometric Coefficient of Variation 26.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 56 weeksPopulation: Safety population included all participants who have taken at least 1 dose of study drug.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
Outcome measures
| Measure |
IM CAB 600 mg
n=15 Participants
Participants received single IM dose of 600 mg of CAB LA injection on left side of lateral thigh on day 1 of injection phase.
|
Injection Phase - CAB 600mg + RPV 900mg
n=14 Participants
Participants received single intramuscular (IM) dose of 600 mg of CAB LA injection on left and 900 mg of RPV LA injection on right side of lateral thigh on day 1 of injection phase (IP).
|
Follow-up Phase - CAB 600mg + RPV 900mg
n=14 Participants
Participant who received 600 mg of CAB LA 900 mg of RPV LA injection during injection phase returned for safety assessments and additional PK sampling post injection in follow-up phase.
|
|---|---|---|---|
|
Number of Participants With Liver Related Adverse Events (AEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 56 weeksPopulation: Safety population
Blood samples were collected to assess abnormalities related to liver.
Outcome measures
| Measure |
IM CAB 600 mg
n=15 Participants
Participants received single IM dose of 600 mg of CAB LA injection on left side of lateral thigh on day 1 of injection phase.
|
Injection Phase - CAB 600mg + RPV 900mg
n=14 Participants
Participants received single intramuscular (IM) dose of 600 mg of CAB LA injection on left and 900 mg of RPV LA injection on right side of lateral thigh on day 1 of injection phase (IP).
|
Follow-up Phase - CAB 600mg + RPV 900mg
n=14 Participants
Participant who received 600 mg of CAB LA 900 mg of RPV LA injection during injection phase returned for safety assessments and additional PK sampling post injection in follow-up phase.
|
|---|---|---|---|
|
Number of Participants With Liver Related Abnormalities
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Oral lead-in Phase - Cabotegravir (CAB) 30 Microgram (mg) + Rilpivirine (RPV) 25mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Injection Phase - CAB 600mg + RPV 900mg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Follow-up Phase - CAB 600mg + RPV 900mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oral lead-in Phase - Cabotegravir (CAB) 30 Microgram (mg) + Rilpivirine (RPV) 25mg
n=15 participants at risk
Participants received 30 mg of CAB tablets orally along with 25 mg of RPV tablets once daily with meal from day 1 to day 28 of oral lead-in (OLI) phase.
|
Injection Phase - CAB 600mg + RPV 900mg
n=14 participants at risk
Participants received single intramuscular (IM) dose of 600 mg of CAB LA injection on left and 900 mg of RPV LA injection on right side of lateral thigh on day 1 of injection phase (IP).
|
Follow-up Phase - CAB 600mg + RPV 900mg
n=14 participants at risk
Participant who received 600 mg of CAB LA 900 mg of RPV LA injection during injection phase returned for safety assessments and additional PK sampling post injection in follow-up phase.
|
|---|---|---|---|
|
Eye disorders
Blepharitis
|
0.00%
0/15 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
7.1%
1/14 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
|
General disorders
Chills
|
0.00%
0/15 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
21.4%
3/14 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
|
General disorders
Feeling hot
|
0.00%
0/15 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
7.1%
1/14 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
|
General disorders
Injection site bruising
|
0.00%
0/15 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
28.6%
4/14 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
|
General disorders
Injection site erythema
|
0.00%
0/15 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
57.1%
8/14 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
|
General disorders
Injection site induration
|
0.00%
0/15 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
50.0%
7/14 • Number of events 7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
|
General disorders
Injection site pain
|
0.00%
0/15 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
100.0%
14/14 • Number of events 14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
|
General disorders
Injection site pruritus
|
0.00%
0/15 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
14.3%
2/14 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
|
General disorders
Injection site swelling
|
0.00%
0/15 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
42.9%
6/14 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
|
General disorders
Injection site warmth
|
0.00%
0/15 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
21.4%
3/14 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
|
Infections and infestations
COVID-19
|
0.00%
0/15 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
7.1%
1/14 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/15 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
7.1%
1/14 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
6.7%
1/15 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/15 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
7.1%
1/14 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/15 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
7.1%
1/14 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/15 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
14.3%
2/14 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
7.1%
1/14 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/15 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
7.1%
1/14 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
|
Surgical and medical procedures
Abortion induced
|
6.7%
1/15 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
0.00%
0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 56 weeks.
Safety population included all participants who have taken at least 1 dose of study drug.
|
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