Trial Outcomes & Findings for AZD7442 Pharmacokinetics, Pharmacodynamics, and Safety Evaluation in Pediatrics (NCT NCT05281601)
NCT ID: NCT05281601
Last Updated: 2025-04-18
Results Overview
The tmax of AZD7442 after a single IM or IV dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
46 participants
Primary outcome timeframe
Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
Results posted on
2025-04-18
Participant Flow
The study was conducted from 21 March 2022 to 16 April 2024 at 11 sites in 5 countries worldwide.
Participants who met the inclusion criteria and none of the exclusion criteria were enrolled to the study. All study assessments were performed as per the schedule of assessment.
Participant milestones
| Measure |
Cohort 1
Participants who were SARS-CoV-2 RT-PCR negative received single dose of AZD7442 on Day 1, either as intramuscularly (IM) (AZD8895 followed by AZD1061) or as intravenously (IV) (AZD8895 + AZD1061 concurrently)
|
Cohort 2
Participants who were SARS-CoV-2 RT-PCR positive received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently).
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
2
|
|
Overall Study
COMPLETED
|
37
|
1
|
|
Overall Study
NOT COMPLETED
|
7
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1
Participants who were SARS-CoV-2 RT-PCR negative received single dose of AZD7442 on Day 1, either as intramuscularly (IM) (AZD8895 followed by AZD1061) or as intravenously (IV) (AZD8895 + AZD1061 concurrently)
|
Cohort 2
Participants who were SARS-CoV-2 RT-PCR positive received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently).
|
|---|---|---|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Withdrawal by parent/guardian
|
2
|
1
|
Baseline Characteristics
AZD7442 Pharmacokinetics, Pharmacodynamics, and Safety Evaluation in Pediatrics
Baseline characteristics by cohort
| Measure |
Cohort 1
n=44 Participants
Participants who were SARS-CoV-2 RT-PCR negative received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently)
|
Cohort 2
n=2 Participants
Participants who were SARS-CoV-2 RT-PCR positive received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently).
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
44 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
11 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Multiple
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
28 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: IM - Day 4, Day 8, Day 11, Day 15 and Day 366; IV - Day 1, Day 4, Day 8, Day 11, Day 15 and Day 366Population: The PK set consisted of all participants who received AZD7442 and from whom PK blood samples were assumed not to be affected by factors such as protocol violations, and who had at least one quantifiable serum PK observation post-dose.
The serum concentrations of AZD7442 after a single IM or IV dose in pediatric participants were evaluated. The serum concentrations for each scheduled time point were summarized by route of administration using appropriate descriptive statistics, based on the (Pharmacokinetic analysis) PK analysis set.
Outcome measures
| Measure |
Cohort 1
n=20 Participants
Participants who were SARS-CoV-2 RT-PCR negative received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently)
|
Cohort 2
n=1 Participants
Participants who were SARS-CoV-2 RT-PCR positive received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently).
|
|---|---|---|
|
Serum Concentrations of AZD7442
Day 4 AZD7442 intramuscular
|
86.32 Microgram per milliliter (ug/mL)
Geometric Coefficient of Variation 72.72
|
—
|
|
Serum Concentrations of AZD7442
Day 8 AZD7442 intramuscular
|
91.88 Microgram per milliliter (ug/mL)
Geometric Coefficient of Variation 86.03
|
—
|
|
Serum Concentrations of AZD7442
Day 11 AZD7442 intramuscular
|
92.49 Microgram per milliliter (ug/mL)
Geometric Coefficient of Variation 20.91
|
—
|
|
Serum Concentrations of AZD7442
Day 15 AZD7442 intramuscular
|
84.69 Microgram per milliliter (ug/mL)
Geometric Coefficient of Variation 33.69
|
—
|
|
Serum Concentrations of AZD7442
Day 366 AZD7442 intramuscular
|
4.084 Microgram per milliliter (ug/mL)
Geometric Coefficient of Variation 57.91
|
—
|
|
Serum Concentrations of AZD7442
Day 1 AZD7442 intravenous
|
199.9 Microgram per milliliter (ug/mL)
Geometric Coefficient of Variation 23.16
|
NA Microgram per milliliter (ug/mL)
Geometric Coefficient of Variation NA
Data were not reported due to presence of insufficient number of participants at that timepoint for analysis as is pre-specified in SAP.
|
|
Serum Concentrations of AZD7442
Day 4 AZD7442 intravenous
|
NA Microgram per milliliter (ug/mL)
Geometric Coefficient of Variation NA
Data were not reported due to presence of insufficient number of participants at that timepoint for analysis as is pre-specified in SAP.
|
—
|
|
Serum Concentrations of AZD7442
Day 8 AZD7442 intravenous
|
89.47 Microgram per milliliter (ug/mL)
Geometric Coefficient of Variation 30.60
|
—
|
|
Serum Concentrations of AZD7442
Day 11 AZD7442 intravenous
|
95.02 Microgram per milliliter (ug/mL)
Geometric Coefficient of Variation 20.35
|
—
|
|
Serum Concentrations of AZD7442
Day 15 AZD7442 intravenous
|
NA Microgram per milliliter (ug/mL)
Geometric Coefficient of Variation NA
Data were not reported due to presence of insufficient number of participants at that timepoint for analysis as is pre-specified in SAP.
|
NA Microgram per milliliter (ug/mL)
Geometric Coefficient of Variation NA
Data were not reported due to presence of insufficient number of participants at that timepoint for analysis as is pre-specified in SAP.
|
|
Serum Concentrations of AZD7442
Day 366 AZD7442 intravenous
|
2.047 Microgram per milliliter (ug/mL)
Geometric Coefficient of Variation 74.56
|
NA Microgram per milliliter (ug/mL)
Geometric Coefficient of Variation NA
Data were not reported due to presence of insufficient number of participants at that timepoint for analysis as is pre-specified in SAP.
|
PRIMARY outcome
Timeframe: Day 1 to Day 366 or early discontinuation visit (approximately [approx.] 24 months)Population: The PK analysis set consisted of all participants who received AZD7442 and from whom PK blood samples were assumed not to be affected by factors such as protocol violations, and who had at least one quantifiable serum PK observation post-dose.
The Cmax of AZD7442 after a single IM or IV dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
Outcome measures
| Measure |
Cohort 1
n=24 Participants
Participants who were SARS-CoV-2 RT-PCR negative received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently)
|
Cohort 2
n=1 Participants
Participants who were SARS-CoV-2 RT-PCR positive received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently).
|
|---|---|---|
|
Maximum Serum Concentration (Cmax)
AZD7442 intramuscular
|
92.47 Microgram per milliliter (ug/mL)
Geometric Coefficient of Variation 44.22
|
—
|
|
Maximum Serum Concentration (Cmax)
AZD7442 intravenous
|
189.3 Microgram per milliliter (ug/mL)
Geometric Coefficient of Variation 27.72
|
NA Microgram per milliliter (ug/mL)
Geometric Coefficient of Variation NA
Data were not reported due to presence of insufficient number of participants at that timepoint for analysis as is pre-specified in SAP.
|
PRIMARY outcome
Timeframe: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)Population: The PK analysis set consisted of all participants who received AZD7442 and from whom PK blood samples were assumed not to be affected by factors such as protocol violations, and who had at least one quantifiable serum PK observation post-dose.
The tmax of AZD7442 after a single IM or IV dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
Outcome measures
| Measure |
Cohort 1
n=24 Participants
Participants who were SARS-CoV-2 RT-PCR negative received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently)
|
Cohort 2
n=1 Participants
Participants who were SARS-CoV-2 RT-PCR positive received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently).
|
|---|---|---|
|
Time to Reach Maximum Serum Concentration (Tmax)
AZD7442 intramuscular
|
11.44 Day
Interval 0.76 to 32.73
|
—
|
|
Time to Reach Maximum Serum Concentration (Tmax)
AZD7442 intravenous
|
0.01 Day
Interval 0.01 to 9.95
|
NA Day
Interval 0.01 to 0.01
Data were not reported due to presence of insufficient number of participants at that timepoint for analysis as is pre-specified in SAP.
|
PRIMARY outcome
Timeframe: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)Population: The PK analysis set consisted of all participants who received AZD7442 and from whom PK blood samples were assumed not to be affected by factors such as protocol violations, and who had at least one quantifiable serum PK observation post-dose.
The t1/2 of AZD7442 after a single IM or IV dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
Outcome measures
| Measure |
Cohort 1
n=22 Participants
Participants who were SARS-CoV-2 RT-PCR negative received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently)
|
Cohort 2
n=1 Participants
Participants who were SARS-CoV-2 RT-PCR positive received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently).
|
|---|---|---|
|
Terminal Half-life (t1/2)
AZD7442 intramuscular
|
78.95 Day
Geometric Coefficient of Variation 24.21
|
—
|
|
Terminal Half-life (t1/2)
AZD7442 intravenous
|
65.61 Day
Geometric Coefficient of Variation 22.38
|
NA Day
Geometric Coefficient of Variation NA
Data were not reported due to presence of insufficient number of participants at that timepoint for analysis as is pre-specified in SAP.
|
PRIMARY outcome
Timeframe: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)Population: The PK analysis set consisted of all participants who received AZD7442 and from whom PK blood samples were assumed not to be affected by factors such as protocol violations, and who had at least one quantifiable serum PK observation post-dose.
The AUC0-last of AZD7442 after a single IM or IV dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
Outcome measures
| Measure |
Cohort 1
n=23 Participants
Participants who were SARS-CoV-2 RT-PCR negative received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently)
|
Cohort 2
n=1 Participants
Participants who were SARS-CoV-2 RT-PCR positive received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently).
|
|---|---|---|
|
Area Under the Serum Concentration Versus Time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-last)
AZD7442 intramuscular
|
9884 Day*ug/mL
Geometric Coefficient of Variation 42.84
|
—
|
|
Area Under the Serum Concentration Versus Time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-last)
AZD7442 intravenous
|
9342 Day*ug/mL
Geometric Coefficient of Variation 36.45
|
NA Day*ug/mL
Geometric Coefficient of Variation NA
Data were not reported due to presence of insufficient number of participants at that timepoint for analysis as is pre-specified in SAP.
|
PRIMARY outcome
Timeframe: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)Population: The PK analysis set consisted of all participants who received AZD7442 and from whom PK blood samples were assumed not to be affected by factors such as protocol violations, and who had at least one quantifiable serum PK observation post-dose.
The AUC0-inf of AZD7442 after a single IM or IV dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
Outcome measures
| Measure |
Cohort 1
n=22 Participants
Participants who were SARS-CoV-2 RT-PCR negative received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently)
|
Cohort 2
n=1 Participants
Participants who were SARS-CoV-2 RT-PCR positive received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently).
|
|---|---|---|
|
Area Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf)
AZD7442 intramuscular
|
11000 Day*ug/mL
Geometric Coefficient of Variation 38.03
|
—
|
|
Area Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf)
AZD7442 intravenous
|
10870 Day*ug/mL
Geometric Coefficient of Variation 21.09
|
NA Day*ug/mL
Geometric Coefficient of Variation NA
Data were not reported due to presence of insufficient number of participants at that timepoint for analysis as is pre-specified in SAP.
|
PRIMARY outcome
Timeframe: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)Population: The PK analysis set consisted of all participants who received AZD7442 and from whom PK blood samples were assumed not to be affected by factors such as protocol violations, and who had at least one quantifiable serum PK observation post-dose.
The tlast of AZD7442 after a single IM or IV dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
Outcome measures
| Measure |
Cohort 1
n=24 Participants
Participants who were SARS-CoV-2 RT-PCR negative received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently)
|
Cohort 2
n=1 Participants
Participants who were SARS-CoV-2 RT-PCR positive received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently).
|
|---|---|---|
|
Time to Last Measurable Concentration (Tlast)
AZD7442 intramuscular
|
351.38 Day
Interval 0.76 to 401.0
|
—
|
|
Time to Last Measurable Concentration (Tlast)
AZD7442 intravenous
|
355.97 Day
Interval 33.81 to 377.26
|
NA Day
Interval 354.9 to 354.9
Data were not reported due to presence of insufficient number of participants at that timepoint for analysis as is pre-specified in SAP.
|
PRIMARY outcome
Timeframe: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)Population: The PK analysis set consisted of all participants who received AZD7442 and from whom PK blood samples were assumed not to be affected by factors such as protocol violations, and who had at least one quantifiable serum PK observation post-dose.
The %AUCex of AZD7442 after a single IM or IV dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
Outcome measures
| Measure |
Cohort 1
n=22 Participants
Participants who were SARS-CoV-2 RT-PCR negative received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently)
|
Cohort 2
n=1 Participants
Participants who were SARS-CoV-2 RT-PCR positive received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently).
|
|---|---|---|
|
Percentage of AUC0-inf Extrapolated to Infinity (% AUCex)
AZD7442 intramuscular
|
4.799 Percentage of AUC extrapolated to ∞
Geometric Coefficient of Variation 78.26
|
—
|
|
Percentage of AUC0-inf Extrapolated to Infinity (% AUCex)
AZD7442 intravenous
|
3.018 Percentage of AUC extrapolated to ∞
Geometric Coefficient of Variation 179.9
|
NA Percentage of AUC extrapolated to ∞
Geometric Coefficient of Variation NA
Data were not reported due to presence of insufficient number of participants at that timepoint for analysis as is pre-specified in SAP.
|
PRIMARY outcome
Timeframe: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)Population: The PK analysis set consisted of all participants who received AZD7442 and from whom PK blood samples were assumed not to be affected by factors such as protocol violations, and who had at least one quantifiable serum PK observation post-dose.
The CL/F of AZD7442 after a single IM dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
Outcome measures
| Measure |
Cohort 1
n=22 Participants
Participants who were SARS-CoV-2 RT-PCR negative received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently)
|
Cohort 2
Participants who were SARS-CoV-2 RT-PCR positive received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently).
|
|---|---|---|
|
Apparent Total Clearance (CL/F)
|
0.04807 Liter/day
Geometric Coefficient of Variation 75.26
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)Population: The PK analysis set consisted of all participants who received AZD7442 and from whom PK blood samples were assumed not to be affected by factors such as protocol violations, and who had at least one quantifiable serum PK observation post-dose.
The Vz/F of AZD7442 after a single IM dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
Outcome measures
| Measure |
Cohort 1
n=22 Participants
Participants who were SARS-CoV-2 RT-PCR negative received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently)
|
Cohort 2
Participants who were SARS-CoV-2 RT-PCR positive received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently).
|
|---|---|---|
|
Apparent Volume of Distribution Based on Terminal Phase (Vz/F)
|
5.475 Liter
Geometric Coefficient of Variation 98.74
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)Population: The PK analysis set consisted of all participants who received AZD7442 and from whom PK blood samples were assumed not to be affected by factors such as protocol violations, and who had at least one quantifiable serum PK observation post-dose.
The CL of AZD7442 after a single IV dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
Outcome measures
| Measure |
Cohort 1
n=17 Participants
Participants who were SARS-CoV-2 RT-PCR negative received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently)
|
Cohort 2
n=1 Participants
Participants who were SARS-CoV-2 RT-PCR positive received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently).
|
|---|---|---|
|
Systemic Clearance (CL)
|
0.02759 Liter/day
Geometric Coefficient of Variation 21.09
|
NA Liter/day
Geometric Coefficient of Variation NA
Data were not reported due to presence of insufficient number of participants at that timepoint for analysis as is pre-specified in SAP.
|
PRIMARY outcome
Timeframe: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)Population: The PK analysis set consisted of all participants who received AZD7442 and from whom PK blood samples were assumed not to be affected by factors such as protocol violations, and who had at least one quantifiable serum PK observation post-dose.
The Vss of AZD7442 after a single IV dose in pediatric participants was evaluated. The PK parameters were summarized by route of administration using appropriate descriptive statistics based on the PK analysis set.
Outcome measures
| Measure |
Cohort 1
n=17 Participants
Participants who were SARS-CoV-2 RT-PCR negative received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently)
|
Cohort 2
n=1 Participants
Participants who were SARS-CoV-2 RT-PCR positive received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently).
|
|---|---|---|
|
Volume of Distribution at Steady State (Vss)
|
2.605 Liter
Geometric Coefficient of Variation 20.34
|
NA Liter
Geometric Coefficient of Variation NA
Data were not reported due to presence of insufficient number of participants at that timepoint for analysis as is pre-specified in SAP.
|
PRIMARY outcome
Timeframe: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)Population: The SAF consisted of all participants who had received IMP.
The safety and tolerability of AZD7442 after a single IM or IV dose in pediatric participants was evaluated.
Outcome measures
| Measure |
Cohort 1
n=44 Participants
Participants who were SARS-CoV-2 RT-PCR negative received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently)
|
Cohort 2
n=2 Participants
Participants who were SARS-CoV-2 RT-PCR positive received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently).
|
|---|---|---|
|
Number of Participants With Adverse Events (AE)
Any AE
|
39 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events (AE)
Any Serious Adverse Event (SAE)
|
8 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AE)
Any Severe AE
|
6 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AE)
Any SAE with outcome death
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AE)
Any AE leading to study discontinuation
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AE)
Any possibly related AE
|
3 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AE)
Any possibly related SAE
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AE)
Any possibly related Severe AE
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AE)
Any possibly related Adverse Event of Special interest (AESI)
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to day 366 or early discontinuation visit (approx. 24 months)Population: The SAF consisted of all participants who had received IMP.
Number of pediatric participants with AESI after a single IM or IV dose were evaluated. An AESI is a pre-specified medically significant event that has the potential to be causally associated with a vaccine product.
Outcome measures
| Measure |
Cohort 1
n=44 Participants
Participants who were SARS-CoV-2 RT-PCR negative received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently)
|
Cohort 2
n=2 Participants
Participants who were SARS-CoV-2 RT-PCR positive received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently).
|
|---|---|---|
|
Number of Participants With Adverse Event of Special Interest (AESI)
|
1 Participants
Interval 0.1 to 12.0
|
0 Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)Population: The AZD7442 ADA Evaluable Analysis Set (ADS3) consisted of all participants who were AZD8895 ADA evaluable and/or AZD1061 ADA evaluable.
The immunogenicity profile of AZD7442 after a single IM or IV dose in pediatric participants was evaluated. A participant is defined as ADA-positive to AZD7442 if they have a positive ADA result to AZD8895 and/or AZD1061 at any time, including baseline and all postbaseline.
Outcome measures
| Measure |
Cohort 1
n=44 Participants
Participants who were SARS-CoV-2 RT-PCR negative received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently)
|
Cohort 2
n=2 Participants
Participants who were SARS-CoV-2 RT-PCR positive received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently).
|
|---|---|---|
|
Number of Participants With Positive Antidrug Antibodies (ADA) Result to AZD7442.
AZD7442 intramuscular ADA positive subject
|
2 Participants
|
0 Participants
|
|
Number of Participants With Positive Antidrug Antibodies (ADA) Result to AZD7442.
AZD7442 intravenous ADA positive subject
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)Population: The SAF consisted of all participants who had received IMP.
Percentage of participants with progression of COVID-19 through Day 29 in Cohort 2 in pediatric participants was evaluated.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants who were SARS-CoV-2 RT-PCR negative received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently)
|
Cohort 2
Participants who were SARS-CoV-2 RT-PCR positive received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently).
|
|---|---|---|
|
Cohort 2 - Percentage of Participants With Progression of COVID-19 Through Day 29
|
0 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)Population: The SAF consisted of all participants who had received IMP.
Number of participants with COVID-19 related death occurring after dosing with IMP through 90 days in Cohort 2 in pediatric participants were evaluated.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants who were SARS-CoV-2 RT-PCR negative received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently)
|
Cohort 2
Participants who were SARS-CoV-2 RT-PCR positive received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently).
|
|---|---|---|
|
Cohort 2 - Number of Participants With COVID-19 Related Death Occurring After Dosing With IMP Through 90 Days
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 31 to Day 366 or early discontinuation visit (approx. 24 months)Population: The SARS-CoV-2 nAb Evaluable Analysis Set (SES) consisted of all participants in the Safety Analysis Set from whom blood samples were assumed not to be affected by factors such as protocol violations, and who had at least one quantifiable serum titer observation post dose.
The pharmacodynamics of AZD7442 after a single dose in pediatric participants was evaluated. The result for overall vaccination status were presented.
Outcome measures
| Measure |
Cohort 1
n=23 Participants
Participants who were SARS-CoV-2 RT-PCR negative received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently)
|
Cohort 2
n=1 Participants
Participants who were SARS-CoV-2 RT-PCR positive received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently).
|
|---|---|---|
|
Titre of SARS-CoV-2 Neutralizing Antibodies
Intramuscular Day 31
|
52720 ug/mL
Interval 355.0 to 139000.0
|
—
|
|
Titre of SARS-CoV-2 Neutralizing Antibodies
Intramuscular Day 366
|
1699 ug/mL
Interval 143.0 to 4340.0
|
—
|
|
Titre of SARS-CoV-2 Neutralizing Antibodies
Intravenous Day 31
|
52950 ug/mL
Interval 20800.0 to 120000.0
|
NA ug/mL
Interval 19800.0 to 19800.0
Data were not reported due to presence of insufficient number of participants at that timepoint for analysis as is pre-specified in SAP.
|
|
Titre of SARS-CoV-2 Neutralizing Antibodies
Intravenous Day 366
|
1078 ug/mL
Interval 398.0 to 4460.0
|
NA ug/mL
Interval 252.0 to 252.0
Data were not reported due to presence of insufficient number of participants at that timepoint for analysis as is pre-specified in SAP.
|
SECONDARY outcome
Timeframe: Day 1 to Day 366 or early discontinuation visit (approx. 24 months)Population: The SAF consisted of all participants who had received IMP.
Number of participants with SARS-CoV-2 infections with or without COVID-19 symptoms after a single IM or IV dose of AZD7442 in pediatric participants were evaluated.
Outcome measures
| Measure |
Cohort 1
n=44 Participants
Participants who were SARS-CoV-2 RT-PCR negative received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently)
|
Cohort 2
Participants who were SARS-CoV-2 RT-PCR positive received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently).
|
|---|---|---|
|
Cohort 1 (Prophylaxis) - Number of Participants With SARS-CoV-2 Infections
Overall
|
10 Participants
|
—
|
|
Cohort 1 (Prophylaxis) - Number of Participants With SARS-CoV-2 Infections
Intramuscular administration
|
7 Participants
|
—
|
|
Cohort 1 (Prophylaxis) - Number of Participants With SARS-CoV-2 Infections
Intravenous administration
|
3 Participants
|
—
|
Adverse Events
Cohort 1
Serious events: 8 serious events
Other events: 34 other events
Deaths: 1 deaths
Cohort 2
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=44 participants at risk
Participants who were SARS-CoV-2 RT-PCR negative received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently)
|
Cohort 2
n=2 participants at risk
Participants who were SARS-CoV-2 RT-PCR positive received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently).
|
|---|---|---|
|
Infections and infestations
Croup infectious
|
2.3%
1/44 • Number of events 1 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
0.00%
0/2 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
|
Infections and infestations
Device related sepsis
|
2.3%
1/44 • Number of events 1 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
0.00%
0/2 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
|
Infections and infestations
Gastroenteritis Escherichia coli
|
2.3%
1/44 • Number of events 1 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
0.00%
0/2 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
2.3%
1/44 • Number of events 1 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
0.00%
0/2 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
|
Infections and infestations
Metapneumovirus infection
|
2.3%
1/44 • Number of events 1 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
0.00%
0/2 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
|
Infections and infestations
Respiratory tract infection viral
|
2.3%
1/44 • Number of events 1 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
0.00%
0/2 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
|
Infections and infestations
Rhinovirus infection
|
2.3%
1/44 • Number of events 1 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
0.00%
0/2 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
|
Infections and infestations
Sepsis
|
2.3%
1/44 • Number of events 1 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
0.00%
0/2 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/44 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
50.0%
1/2 • Number of events 1 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.3%
1/44 • Number of events 1 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
0.00%
0/2 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.3%
1/44 • Number of events 1 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
0.00%
0/2 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
2.3%
1/44 • Number of events 1 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
0.00%
0/2 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.3%
1/44 • Number of events 5 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
0.00%
0/2 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
|
Gastrointestinal disorders
Stomatitis
|
2.3%
1/44 • Number of events 1 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
0.00%
0/2 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
|
Immune system disorders
Anaphylactic reaction
|
2.3%
1/44 • Number of events 1 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
0.00%
0/2 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
2.3%
1/44 • Number of events 1 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
0.00%
0/2 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.3%
1/44 • Number of events 1 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
0.00%
0/2 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/44 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
50.0%
1/2 • Number of events 1 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
2.3%
1/44 • Number of events 1 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
0.00%
0/2 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
2.3%
1/44 • Number of events 1 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
0.00%
0/2 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
|
Skin and subcutaneous tissue disorders
Henoch-Schonlein purpura
|
2.3%
1/44 • Number of events 1 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
0.00%
0/2 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
Other adverse events
| Measure |
Cohort 1
n=44 participants at risk
Participants who were SARS-CoV-2 RT-PCR negative received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently)
|
Cohort 2
n=2 participants at risk
Participants who were SARS-CoV-2 RT-PCR positive received single dose of AZD7442 on Day 1, either as IM (AZD8895 followed by AZD1061) or as IV (AZD8895 + AZD1061 concurrently).
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
27.3%
12/44 • Number of events 27 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
0.00%
0/2 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
|
Infections and infestations
Viral infection
|
25.0%
11/44 • Number of events 13 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
0.00%
0/2 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
|
Infections and infestations
COVID-19
|
22.7%
10/44 • Number of events 10 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
0.00%
0/2 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
|
Infections and infestations
Acute sinusitis
|
9.1%
4/44 • Number of events 7 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
0.00%
0/2 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
|
Infections and infestations
Otitis media acute
|
9.1%
4/44 • Number of events 4 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
0.00%
0/2 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
|
Infections and infestations
Pharyngitis streptococcal
|
9.1%
4/44 • Number of events 4 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
0.00%
0/2 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
|
Infections and infestations
Influenza
|
6.8%
3/44 • Number of events 3 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
0.00%
0/2 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
|
Infections and infestations
Nasopharyngitis
|
6.8%
3/44 • Number of events 7 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
0.00%
0/2 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
|
Infections and infestations
Ear infection
|
0.00%
0/44 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
50.0%
1/2 • Number of events 2 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.7%
10/44 • Number of events 10 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
0.00%
0/2 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
|
Gastrointestinal disorders
Nausea
|
9.1%
4/44 • Number of events 4 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
0.00%
0/2 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
4/44 • Number of events 4 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
0.00%
0/2 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.8%
3/44 • Number of events 3 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
0.00%
0/2 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
|
Nervous system disorders
Headache
|
9.1%
4/44 • Number of events 4 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
0.00%
0/2 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
|
Investigations
SARS-CoV-2 test positive
|
6.8%
3/44 • Number of events 3 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
0.00%
0/2 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
|
Investigations
Influenza A virus test positive
|
0.00%
0/44 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
50.0%
1/2 • Number of events 1 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/44 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
50.0%
1/2 • Number of events 1 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
|
General disorders
Pyrexia
|
15.9%
7/44 • Number of events 13 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
50.0%
1/2 • Number of events 1 • Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No unpublished information may be disclosed without prior written approval from AstraZeneca.
- Publication restrictions are in place
Restriction type: OTHER