Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2021-006056-13 | EudraCT Number |
Not provided
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This study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of AZD7442 administered intramuscularly (IM) or intravenously (IV) in pediatric participants aged ≥ 29 weeks GA to < 18 years.
This is a Phase I, open-label, uncontrolled, multi-country, multi-center, single-dose study. Initially, 2 cohorts of participants will be enrolled: 1) participants who are severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) negative at screening and have not knowingly been exposed to a SARS-CoV-2 positive individual (pre-exposure prophylaxis); and 2) participants who are SARS-CoV-2 RT-PCR positive at screening and have mild to moderate COVID-19 symptoms. A third cohort might be added for the treatment of severe COVID-19. If included, this third cohort will include participants who are SARS-CoV-2 positive at screening and have severe COVID-19.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD7442 | Experimental | All participants will receive a single dose of AZD7442 on Day 1, either IM (AZD8895 followed by AZD1061) or IV (AZD8895 + AZD1061 concurrently). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD7442 | Drug | IM Administration: AZD8895 and AZD1061 (comprising AZD7442), must both be administered separately to the participant in a sequential order. IV Administration: AZD7442 is dosed by co-administration of AZD8895 and AZD1061 in a single IV infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentrations of AZD7442 | 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. | 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 366 |
| Maximum Serum Concentration (Cmax) | 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. | Day 1 to Day 366 or early discontinuation visit (approximately [approx.] 24 months) |
| Time to Reach Maximum Serum Concentration (Tmax) | 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. | Day 1 to Day 366 or early discontinuation visit (approx. 24 months) |
| Terminal Half-life (t1/2) | 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. | Day 1 to Day 366 or early discontinuation visit (approx. 24 months) |
| Area Under the Serum Concentration Versus Time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-last) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Positive Antidrug Antibodies (ADA) Result to AZD7442. | 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. | Day 1 to Day 366 or early discontinuation visit (approx. 24 months) |
Not provided
Inclusion Criteria:
COHORT 1
COHORT 2
Note that Cohort 2 will only be included if the indication is progressed in adults.
COHORT 3
Participants will receive IM AZD7442 unless they meet any of the following criteria for IV administration:
Exclusion Criteria:
All Cohorts
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Long Beach | California | 90806 | United States | ||
| Research Site |
Not provided
| Label | URL |
|---|---|
| D8850C00006\_Redacted\_CSP | View source |
| D8850C00006\_Redacted\_CSR\_Synopsi | View source |
Not provided
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Not provided
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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.
The study was conducted from 21 March 2022 to 16 April 2024 at 11 sites in 5 countries worldwide.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Safety Analysis Set (SAF) consisted of all participants who had received investigational medicinal product (IMP).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | 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) |
| BG001 | Cohort 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Serum Concentrations of AZD7442 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter (ug/mL) | 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 366 |
|
Day 1 to Day 366 or early discontinuation visit (approx. 24 months)
The SAF consisted of all participants who had received IMP.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 | 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) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Croup infectious | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 25, 2023 | Dec 17, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 31, 2023 | Dec 17, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C000714168 | cilgavimab and tixagevimab drug combination |
Not provided
Not provided
Not provided
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|
| Day 1 to Day 366 or early discontinuation visit (approx. 24 months) |
| Area Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf) | 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. | Day 1 to Day 366 or early discontinuation visit (approx. 24 months) |
| Time to Last Measurable Concentration (Tlast) | 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. | Day 1 to Day 366 or early discontinuation visit (approx. 24 months) |
| Percentage of AUC0-inf Extrapolated to Infinity (% AUCex) | 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. | Day 1 to Day 366 or early discontinuation visit (approx. 24 months) |
| Apparent Total Clearance (CL/F) | 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. | Day 1 to Day 366 or early discontinuation visit (approx. 24 months) |
| Apparent Volume of Distribution Based on Terminal Phase (Vz/F) | 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. | Day 1 to Day 366 or early discontinuation visit (approx. 24 months) |
| Systemic Clearance (CL) | 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. | Day 1 to Day 366 or early discontinuation visit (approx. 24 months) |
| Volume of Distribution at Steady State (Vss) | 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. | Day 1 to Day 366 or early discontinuation visit (approx. 24 months) |
| Number of Participants With Adverse Events (AE) | The safety and tolerability of AZD7442 after a single IM or IV dose in pediatric participants was evaluated. | Day 1 to Day 366 or early discontinuation visit (approx. 24 months) |
| Number of Participants With Adverse Event of Special Interest (AESI) | 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. | Day 1 to day 366 or early discontinuation visit (approx. 24 months) |
| Cohort 2 - Percentage of Participants With Progression of COVID-19 Through Day 29 | Percentage of participants with progression of COVID-19 through Day 29 in Cohort 2 in pediatric participants was evaluated. | Day 1 to Day 366 or early discontinuation visit (approx. 24 months) |
| Cohort 2 - Number of Participants With COVID-19 Related Death Occurring After Dosing With IMP Through 90 Days | Number of participants with COVID-19 related death occurring after dosing with IMP through 90 days in Cohort 2 in pediatric participants were evaluated. | Day 1 to Day 366 or early discontinuation visit (approx. 24 months) |
| Titre of SARS-CoV-2 Neutralizing Antibodies | The pharmacodynamics of AZD7442 after a single dose in pediatric participants was evaluated. The result for overall vaccination status were presented. | Day 31 to Day 366 or early discontinuation visit (approx. 24 months) |
| Cohort 1 (Prophylaxis) - Number of Participants With SARS-CoV-2 Infections | 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. | Day 1 to Day 366 or early discontinuation visit (approx. 24 months) |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Research Site | Washington D.C. | District of Columbia | 20007 | United States |
| Research Site | Idaho Falls | Idaho | 83404 | United States |
| Research Site | Stony Brook | New York | 11794 | United States |
| Research Site | Providence | Rhode Island | 02903 | United States |
| Research Site | Mt. Pleasant | South Carolina | 29464 | United States |
| Research Site | Leuven | 3000 | Belgium |
| Research Site | Belo Horizonte | 30130-100 | Brazil |
| Research Site | Frankfurt am Main | 60590 | Germany |
| Research Site | Southampton | SO16 6YD | United Kingdom |
| D8850C00006\_Redacted\_SAP. | View source |
| Death |
|
| Withdrawal by parent/guardian |
|
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).
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | 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). |
|
|
| Primary | Maximum Serum Concentration (Cmax) | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter (ug/mL) | Day 1 to Day 366 or early discontinuation visit (approximately [approx.] 24 months) |
|
|
|
| Primary | Time to Reach Maximum Serum Concentration (Tmax) | 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. | 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. | Posted | Median | Full Range | Day | Day 1 to Day 366 or early discontinuation visit (approx. 24 months) |
|
|
|
| Primary | Terminal Half-life (t1/2) | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Day | Day 1 to Day 366 or early discontinuation visit (approx. 24 months) |
|
|
|
| Primary | Area Under the Serum Concentration Versus Time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-last) | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Day*ug/mL | Day 1 to Day 366 or early discontinuation visit (approx. 24 months) |
|
|
|
| Primary | Area Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf) | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Day*ug/mL | Day 1 to Day 366 or early discontinuation visit (approx. 24 months) |
|
|
|
| Primary | Time to Last Measurable Concentration (Tlast) | 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. | 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. | Posted | Median | Full Range | Day | Day 1 to Day 366 or early discontinuation visit (approx. 24 months) |
|
|
|
| Primary | Percentage of AUC0-inf Extrapolated to Infinity (% AUCex) | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage of AUC extrapolated to ∞ | Day 1 to Day 366 or early discontinuation visit (approx. 24 months) |
|
|
|
| Primary | Apparent Total Clearance (CL/F) | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter/day | Day 1 to Day 366 or early discontinuation visit (approx. 24 months) |
|
|
|
| Primary | Apparent Volume of Distribution Based on Terminal Phase (Vz/F) | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter | Day 1 to Day 366 or early discontinuation visit (approx. 24 months) |
|
|
|
| Primary | Systemic Clearance (CL) | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter/day | Day 1 to Day 366 or early discontinuation visit (approx. 24 months) |
|
|
|
| Primary | Volume of Distribution at Steady State (Vss) | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter | Day 1 to Day 366 or early discontinuation visit (approx. 24 months) |
|
|
|
| Primary | Number of Participants With Adverse Events (AE) | The safety and tolerability of AZD7442 after a single IM or IV dose in pediatric participants was evaluated. | The SAF consisted of all participants who had received IMP. | Posted | Count of Participants | Participants | Day 1 to Day 366 or early discontinuation visit (approx. 24 months) |
|
|
|
| Secondary | Number of Participants With Positive Antidrug Antibodies (ADA) Result to AZD7442. | 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. | The AZD7442 ADA Evaluable Analysis Set (ADS3) consisted of all participants who were AZD8895 ADA evaluable and/or AZD1061 ADA evaluable. | Posted | Count of Participants | Participants | Day 1 to Day 366 or early discontinuation visit (approx. 24 months) |
|
|
|
| Primary | Number of Participants With Adverse Event of Special Interest (AESI) | 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. | The SAF consisted of all participants who had received IMP. | Posted | Count of Participants | Participants | Day 1 to day 366 or early discontinuation visit (approx. 24 months) |
|
|
|
| Secondary | Cohort 2 - Percentage of Participants With Progression of COVID-19 Through Day 29 | Percentage of participants with progression of COVID-19 through Day 29 in Cohort 2 in pediatric participants was evaluated. | The SAF consisted of all participants who had received IMP. | Posted | Number | Percentage of participants | Day 1 to Day 366 or early discontinuation visit (approx. 24 months) |
|
|
|
| Secondary | Cohort 2 - Number of Participants With COVID-19 Related Death Occurring After Dosing With IMP Through 90 Days | Number of participants with COVID-19 related death occurring after dosing with IMP through 90 days in Cohort 2 in pediatric participants were evaluated. | The SAF consisted of all participants who had received IMP. | Posted | Count of Participants | Participants | Day 1 to Day 366 or early discontinuation visit (approx. 24 months) |
|
|
|
| Secondary | Titre of SARS-CoV-2 Neutralizing Antibodies | The pharmacodynamics of AZD7442 after a single dose in pediatric participants was evaluated. The result for overall vaccination status were presented. | 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. | Posted | Geometric Mean | Full Range | ug/mL | Day 31 to Day 366 or early discontinuation visit (approx. 24 months) |
|
|
|
| Secondary | Cohort 1 (Prophylaxis) - Number of Participants With SARS-CoV-2 Infections | 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. | The SAF consisted of all participants who had received IMP. | Posted | Count of Participants | Participants | Day 1 to Day 366 or early discontinuation visit (approx. 24 months) |
|
|
|
| 1 |
| 44 |
| 8 |
| 44 |
| 34 |
| 44 |
| EG001 | 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). | 0 | 2 | 1 | 2 | 2 | 2 |
| Device related sepsis | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
|
| Gastroenteritis Escherichia coli | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
|
| Lower respiratory tract infection bacterial | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
|
| Metapneumovirus infection | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
|
| Respiratory tract infection viral | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
|
| Rhinovirus infection | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Non-systematic Assessment |
|
| Febrile bone marrow aplasia | Blood and lymphatic system disorders | MedDRA 26.1 | Non-systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 26.1 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 26.1 | Non-systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | MedDRA 26.1 | Non-systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 26.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Non-systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 26.1 | Non-systematic Assessment |
|
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 26.1 | Non-systematic Assessment |
|
| Ovarian cyst ruptured | Reproductive system and breast disorders | MedDRA 26.1 | Non-systematic Assessment |
|
| Henoch-Schonlein purpura | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 26.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 26.1 | Non-systematic Assessment |
|
| SARS-CoV-2 test positive | Investigations | MedDRA 26.1 | Non-systematic Assessment |
|
| Influenza A virus test positive | Investigations | MedDRA 26.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 26.1 | Non-systematic Assessment |
|
No unpublished information may be disclosed without prior written approval from AstraZeneca.
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| AZD7442 intravenous |
|
|
| AZD7442 intravenous |
|
|
| AZD7442 intravenous |
|
|
| AZD7442 intravenous |
|
|
| AZD7442 intravenous |
|
|
| AZD7442 intravenous |
|
|
| AZD7442 intravenous |
|
|
| Any Severe AE |
|
| Any SAE with outcome death |
|
| Any AE leading to study discontinuation |
|
| Any possibly related AE |
|
| Any possibly related SAE |
|
| Any possibly related Severe AE |
|
| Any possibly related Adverse Event of Special interest (AESI) |
|
| Intramuscular Day 366 |
|
|
| Intravenous Day 31 |
|
|
| Intravenous Day 366 |
|
|
| Title | Measurements |
|---|---|
|