Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study: Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study
SUPERNOVA
A Phase I/III Randomized, Double-blind Study to Evaluate the Safety, Efficacy and Neutralizing Activity of AZD5156/AZD3152 for Pre-exposure Prophylaxis of COVID-19 in Participants With Conditions Causing Immune Impairment. Sub-study: Phase II Open Label Sub-study to Evaluate the Safety, PK, and Neutralizing Activity of AZD3152 for Pre-exposure Prophylaxis of COVID-19
3 other identifiers
interventional
3,882
18 countries
215
Brief Summary
AZD3152, a single mAb, is being developed to have broad neutralizing activity across known SARS-CoV-2 variants of concern for pre-exposure prophylaxis of COVID-19. The aim of the Phase I/III study (Parent Study) will be to evaluate the safety, efficacy and neutralizing activity of AZD3152 compared with comparator for pre exposure prophylaxis of COVID-19, and separately evaluate the safety and PK of AZD5156, a combination of AZD3152 and AZD1061. Sub-study: This Phase II sub-study of SUPERNOVA will assess the safety, PK, and predicted neutralizing activity of AZD3152 compared with EVUSHELD for pre-exposure prophylaxis of COVID-19.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2022
215 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2022
CompletedFirst Posted
Study publicly available on registry
December 13, 2022
CompletedStudy Start
First participant enrolled
December 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 11, 2025
CompletedMarch 13, 2025
March 1, 2025
1.3 years
November 30, 2022
March 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Parent study - Sentinel Safety Cohort: To evaluate the safety of AZD5156
Occurence of AEs, SAEs, MAAEs, and AESIs will be collected throughout the study
AEs will be collected from IMP administration approximately 90 days following. AESIs will be collected from IMP administration through to Visit 11 (Day 361). SAEs and MAAEs will be collected up to Visit 11 (Day 361).
Parent study - Main Cohort: To evaluate the safety of AZD3152 and EVUSHELD and/or placebo
Occurrence of AEs, SAEs, MAAEs, and AESIs will be collected throughout the study
Occurrence of AEs collected through approximately 90 days after each IMP administration through to Visit 10 (Day 451). SAEs and MAAEs will be collected up to Visit 10 (Day 451).
Parent study-Main cohort: To compare the efficacy of AZD3152 to EVUSHELD and/or placebo in the prevention of symptomatic COVID 19 caused by any SARS-CoV-2 variant
Endpoint: Confirmed symptomatic COVID-19 case, classified as a binary outcome incorporating the time from the first dose of IMP until a participant develops their first symptoms for COVID-19 or are censored. Summary measure: Prophylactic efficacy, calculated as 1 - Hazard Ratio (HR) (AZD3152 versus EVUSHELD and/or placebo) using a hazard regression model.
Confirmed symptomatic COVID-19 case is evaluated from first dose up to 181 days after last dose. For participants that receive two doses, the evaluation period would be approximately 361 days.
Parent study - Main cohort: To compare the efficacy of AZD3152 to EVUSHELD and/or placebo in the prevention of symptomatic COVID 19 attributable to matched variants (variants that do not contain the F456L mutation)
Endpoint: Confirmed symptomatic COVID-19 case attributable to matched variants, classified as a binary outcome incorporating the time from the first dose of IMP until a participant develops their first symptoms for COVID-19 or are censored. Summary measure: Prophylactic efficacy, calculated as 1 - Hazard Ratio (HR) (AZD3152 versus EVUSHELD and/or placebo) using a hazard regression model.
Confirmed symptomatic COVID-19 case is evaluated from first dose up to 181 days after last dose. For participants that receive two doses, the evaluation period would be approximately 361 days.
Sub-study: To evaluate the safety of AZD3152 and EVUSHELD
Occurrence of AEs collected through 29 days after IMP administration for the primary analysis.
SAEs, MAAEs, and AESIs collected throughout the study for the final analysis.
Sub-study: To compare the SARS-CoV-2 nAb responses to a current VOC following AZD3152 administration vs SARS-CoV-2 nAb responses to prior variants following EVUSHELD administration
SARS-CoV-2 nAb responses to a current VOC following AZD3152 administration vs SARS-CoV-2 nAb responses to prior variants following EVUSHELD administration.
Predicted GMT ratio of SARS-CoV-2 nAbs between the treatment arms at Visit 3 (Day 29) for the variant that each IMP is intended to neutralize.
Secondary Outcomes (13)
Parent study - Sentinel Safety Cohort: To characterize the Pharmacokinetics of AZD5156 (AZD1061 and AZD3152) in serum.
Samples will be collected from Visit 1 (Day 1) up to Visit 11 (Day 361).
Parent study - Sentinel Safety Cohort: To characterize the Pharmacokinetics parameter of maximum concentration (Cmax) of AZD5156 (AZD1061 and AZD3152) in serum
Samples will be collected from Visit 1 (Day 1) up to Visit 11 (Day 361)
Parent study - Sentinel Safety Cohort: To characterize the Pharmacokinetics parameter of time to maximum serum concentration (tmax) of AZD5156 (AZD1061 and AZD3152) in serum
Samples will be collected from Visit 1 (Day 1) up to Visit 11 (Day 361).
Parent study - Sentinel Safety Cohort: To characterize the Pharmacokinetics parameter of terminal half-life (t½) of AZD5156 (AZD1061 and AZD3152) in serum
Samples will be collected from Visit 1 (Day 1) up to Visit 11 (Day 361).
Parent study - Sentinel Safety Cohort: To characterize the Pharmacokinetics parameter of area under the concentration-time curve at the last measured time point (AUClast) of AZD5156 (AZD1061 and AZD3152) in serum
Samples will be collected from Visit 1 (Day 1) up to Visit 11 (Day 361).
- +8 more secondary outcomes
Study Arms (14)
Parent study Sentinel Safety Cohort - Subcohort 1a Gluteal - AZD5156
EXPERIMENTALThe Sentinel Safety Cohort of the Parent Study will enroll 56 healthy adults, 18 to 55 years of age, who will be randomized to receive AZD5156 (40 participants) or placebo (16 participants). Participants will be randomized to receive study intervention IM either in the gluteal or the anterolateral thigh. Dosing within the Sentinel Safety Cohort will be staggered, with participants allocated sequentially to 4 subcohorts (1a, 1b, 2a, and 2b).
Parent study Sentinel Safety Cohort - Subcohort 1a Gluteal - Placebo
PLACEBO COMPARATORThe Sentinel Safety Cohort of the Parent study will enroll 56 healthy adults, 18 to 55 years of age, who will be randomized to receive AZD5156 (40 participants) or placebo (16 participants). Participants will be randomized to receive study intervention IM either in the gluteal or the anterolateral thigh. Dosing within the Sentinel Safety Cohort will be staggered, with participants allocated sequentially to 4 subcohorts (1a, 1b, 2a, and 2b).
Parent study Sentinel Safety Cohort - Subcohort 1b Thigh - AZD5156
EXPERIMENTALThe Sentinel Safety Cohort of the Parent study will enroll 56 healthy adults, 18 to 55 years of age, who will be randomized to receive AZD5156 (40 participants) or placebo (16 participants). Participants will be randomized to receive study intervention IM either in the gluteal or the anterolateral thigh. Dosing within the Sentinel Safety Cohort will be staggered, with participants allocated sequentially to 4 subcohorts (1a, 1b, 2a, and 2b).
Parent study Sentinel Safety Cohort - Subcohort 1b Thigh - Placebo
PLACEBO COMPARATORThe Sentinel Safety Cohort of the Parent study will enroll 56 healthy adults, 18 to 55 years of age, who will be randomized to receive AZD5156 (40 participants) or placebo (16 participants). Participants will be randomized to receive study intervention IM either in the gluteal or the anterolateral thigh. Dosing within the Sentinel Safety Cohort will be staggered, with participants allocated sequentially to 4 subcohorts (1a, 1b, 2a, and 2b).
Parent study Sentinel Safety Cohort - Subcohort 2a Gluteal- AZD5156
EXPERIMENTALThe Sentinel Safety Cohort of the Parent study will enroll 56 healthy adults, 18 to 55 years of age, who will be randomized to receive AZD5156 (40 participants) or placebo (16 participants). Participants will be randomized to receive study intervention IM either in the gluteal or the anterolateral thigh. Dosing within the Sentinel Safety Cohort will be staggered, with participants allocated sequentially to 4 subcohorts (1a, 1b, 2a, and 2b).
Parent study Sentinel Safety Cohort - Subcohort 2a Gluteal - Placebo
PLACEBO COMPARATORThe Sentinel Safety Cohort of the Parent study will enroll 56 healthy adults, 18 to 55 years of age, who will be randomized to receive AZD5156 (40 participants) or placebo (16 participants). Participants will be randomized to receive study intervention IM either in the gluteal or the anterolateral thigh. Dosing within the Sentinel Safety Cohort will be staggered, with participants allocated sequentially to 4 subcohorts (1a, 1b, 2a, and 2b).
Parent study Sentinel Safety Cohort - Subcohort 2b Thigh - AZD5156
EXPERIMENTALThe Sentinel Safety Cohort of the Parent study will enroll 56 healthy adults, 18 to 55 years of age, who will be randomized to receive AZD5156 (40 participants) or placebo (16 participants). Participants will be randomized to receive study intervention IM either in the gluteal or the anterolateral thigh. Dosing within the Sentinel Safety Cohort will be staggered, with participants allocated sequentially to 4 subcohorts (1a, 1b, 2a, and 2b).
Parent study Sentinel Safety Cohort - Subcohort 2b Thigh - Placebo
PLACEBO COMPARATORThe Sentinel Safety Cohort of the Parent study will enroll 56 healthy adults, 18 to 55 years of age, who will be randomized to receive AZD5156 (40 participants) or placebo (16 participants). Participants will be randomized to receive study intervention IM either in the gluteal or the anterolateral thigh. Dosing within the Sentinel Safety Cohort will be staggered, with participants allocated sequentially to 4 subcohorts (1a, 1b, 2a, and 2b).
Parent study Main Cohort - AZD3152
EXPERIMENTALThe Main Cohort of the Parent study will enroll approximately 3200 participants. Dosing in the Main Cohort will be staggered, so that it starts with adult participants aged 18 years and older, with no adolescent participants dosed in the Main Cohort until safety data from Visit 2a (Day 8) and Visit 2b (Day 15) have been reviewed by the DSMB for at least 80 adult Main Cohort participants (which will include at least 40 participants who have received AZD3152). Participants in the Main Cohort will be randomized 1:1 to receive AZD3152 300 mg or comparator administered IM in the anterolateral thigh on Day 1. Participants will receive a second dose of their original randomized study intervention (ie, active treatment or comparator) 6 months after Visit 1.
Parent study Main Cohort - EVUSHELD™
ACTIVE COMPARATORParticipants in the Main Cohort of the Parent study will be randomized 1:1 to receive AZD3152 300 mg or comparator administered IM in the anterolateral thigh on Day 1. Participants will receive a second dose of their original randomized study intervention (ie, active treatment or comparator) 6 months after Visit 1. At the request of regulatory authorities the active comparator will be changed to placebo. As the comparator is given on two occasions, this means that a participant randomized to the comparator arm may receive (a) two doses of EVUSHELD, (b) a dose of EVUSHELD and a dose of placebo, or (c) two doses of placebo.
Parent study Main Cohort - Placebo
PLACEBO COMPARATORParticipants in the Main Cohort of the Parent study will be randomized 1:1 to receive AZD3152 300 mg or comparator administered IM in the anterolateral thigh on Day 1. Participants will receive a second dose of their original randomized study intervention (ie, active treatment or comparator) 6 months after Visit 1. At the request of regulatory authorities the active comparator will be changed to placebo. As the comparator is given on two occasions, this means that a participant randomized to the comparator arm may receive (a) two doses of EVUSHELD, (b) a dose of EVUSHELD and a dose of placebo, or (c) two doses of placebo.
Sub-study - AZD3152
EXPERIMENTALThis sub-study will enroll approximately 450 participants, ≥ 18 years of age with a minimum weight of 40 kg. An initial Sentinel Safety Cohort will include 12 healthy volunteers; all other participants in the study will be either immunocompromised or immunocompetent (including healthy participants) with all degrees of SARS-CoV-2 infection risk.
Sub-study - AZD7442 (EVUSHELD™)
ACTIVE COMPARATORThis sub-study will enroll approximately 450 participants, ≥ 18 years of age with a minimum weight of 40 kg. An initial Sentinel Safety Cohort will include 12 healthy volunteers; all other participants in the study will be either immunocompromised or immunocompetent (including healthy participants) with all degrees of SARS-CoV-2 infection risk.
Sub-study - AZD7442 (EVUSHELD™) Immunocompromised participants offered AZD3152 1200mg IV
EXPERIMENTALThis sub-study will enroll approximately 450 participants, ≥ 18 years of age with a minimum weight of 40 kg. An initial Sentinel Safety Cohort will include 12 healthy volunteers; all other participants in the study will be either immunocompromised or immunocompetent (including healthy participants) with all degrees of SARS-CoV-2 infection risk.
Interventions
600 mg AZD5156 consisting of 300 mg AZD1061 at 100 mg/mL and 300 mg AZD3152 at 150 mg/mL 3 mL of AZD1061 2 mL of AZD3152 IM on Visit 1 Day 1
single dose of Placebo (3 mL + 2 mL) IM
600 mg EVUSHELD™/AZD7442 consisting of 300 mg AZD1061 and 300 mg AZD8895, both at 100 mg/mL 2 IM injections (thigh) of 3 mL each IM on Visit 1 Day 1 and on Visit 5 Day 181
300 mg AZD3152 at 150 mg/mL 1 IM injection (thigh) of 2 mL of AZD3152 on Visit 1 Day 1 and on Visit 5 Day 181
Single doses of 0.9% sodium chloride 2 mL IM for injection on Visit 1 Day 1 and Visit 5 Day 181
Single dose 300 mg IM administered on Visit 1 Day 1
Single dose of AZD7442 (EVUSHELD™) 300 mg IM
Eligibility Criteria
You may qualify if:
- Healthy participants according to medical history, physical examination, baseline safety laboratory tests, and screening parameters, according to the judgment of the investigator, with no concomitant disease or concomitant medication (except for medication specifically permitted by the protocol).
- Age 18 to 55 years at the time of signing the informed consent.
- Negative rapid antigen test at Visit 1.
- Weight ≥ 45 kg and ≤ 110 kg at screening.
You may not qualify if:
- Women who are pregnant, lactating, or of childbearing potential and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to study intervention administration and until at least 6 months after study intervention administration.
- Known hypersensitivity to any component of the study intervention.
- Previous hypersensitivity or severe adverse reaction following administration of a mAb.
- Acute (time-limited) or febrile (temperature ≥ 38.0°C \[100.4ºF\]) illness/infection on day prior to or day of planned dosing; participants excluded for transient acute illness may be dosed if illness resolves within the screening period or may be rescreened once.
- Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days prior to Visit 1.
- Clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture.
- Receipt of immunoglobulin (non-COVID related) or blood products within 6 months prior to Visit 1.
- Previous receipt of a mAb against SARS-CoV-2.
- Receipt of a COVID-19 vaccine within 3 months prior to Visit 1.
- Receipt of a COVID-19 antiviral for prophylaxis within 3 months prior to Visit 1
- COVID-19 within 3 months prior to Visit 1 (confirmed either by laboratory testing or a rapid test \[including at home testing\]).
- Receipt of any IMP in the preceding 90 days or expected receipt of IMP during the period of study follow-up, or concurrent participation in another interventional study.
- Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy, including any course of glucocorticoid therapy exceeding 2 weeks of prednisone or equivalent at a dose of 20 mg daily or every other day within 6 months prior to screening.
- Active infection with hepatitis B or C.
- Serum creatinine, AST, or ALT above 1.5 × ULN at screening
- +58 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (215)
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Birmingham, Alabama, 35209, United States
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Birmingham, Alabama, 35215, United States
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Mobile, Alabama, 36608, United States
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Glendale, Arizona, 85306, United States
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Mesa, Arizona, 85206, United States
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Mesa, Arizona, 85210, United States
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Tucson, Arizona, 85712, United States
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Little Rock, Arkansas, 72205, United States
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Colton, California, 92324, United States
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La Mesa, California, 91942, United States
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Long Beach, California, 90815, United States
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Los Angeles, California, 90027, United States
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Modesto, California, 95350, United States
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Sacramento, California, 95817, United States
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Tustin, California, 92780, United States
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Westminster, California, 92683, United States
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Aurora, Colorado, 80014, United States
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Denver, Colorado, 80209, United States
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Denver, Colorado, 80246, United States
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Fort Collins, Colorado, 80525, United States
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New Haven, Connecticut, 06519, United States
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Washington D.C., District of Columbia, 20007, United States
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Coral Gables, Florida, 33134, United States
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Fleming Island, Florida, 32003, United States
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Fort Myers, Florida, 33912, United States
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Hollywood, Florida, 33024, United States
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Jacksonville, Florida, 32216, United States
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Jacksonville, Florida, 32256, United States
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Lake Worth, Florida, 33462, United States
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Largo, Florida, 33777, United States
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Lauderdale Lakes, Florida, 33313, United States
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Leesburg, Florida, 34748, United States
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Medley, Florida, 33166, United States
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Miami, Florida, 33125, United States
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Miami, Florida, 33126, United States
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Miami, Florida, 33135, United States
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Miami, Florida, 33186, United States
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Miami Lakes, Florida, 33014, United States
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Miami Springs, Florida, 33166, United States
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North Miami Beach, Florida, 33162, United States
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Orlando, Florida, 32806, United States
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Ormond Beach, Florida, 32174, United States
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Port Orange, Florida, 32127, United States
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St. Petersburg, Florida, 33713, United States
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Winter Park, Florida, 32789, United States
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Atlanta, Georgia, 30342, United States
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Columbus, Georgia, 31904, United States
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Boise, Idaho, 83712, United States
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Burr Ridge, Illinois, 60527, United States
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Chicago, Illinois, 60612, United States
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Chicago, Illinois, 60640, United States
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Gurnee, Illinois, 60031, United States
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Evansville, Indiana, 47712, United States
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Evansville, Indiana, 47715, United States
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South Bend, Indiana, 46617, United States
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West Des Moines, Iowa, 50266, United States
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Overland Park, Kansas, 66204, United States
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Wichita, Kansas, 67214, United States
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Bowling Green, Kentucky, 42101, United States
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Lexington, Kentucky, 40503, United States
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Lexington, Kentucky, 40509, United States
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Lake Charles, Louisiana, 70605, United States
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Metairie, Louisiana, 70006, United States
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New Orleans, Louisiana, 70119, United States
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Baltimore, Maryland, 21287, United States
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Boston, Massachusetts, 02115, United States
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Boston, Massachusetts, 02215, United States
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Methuen, Massachusetts, 01844, United States
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Springfield, Massachusetts, 01107, United States
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Worcester, Massachusetts, 01655, United States
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Detroit, Michigan, 48202, United States
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Farmington Hills, Michigan, 48334, United States
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Grand Rapids, Michigan, 49525, United States
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Novi, Michigan, 48377, United States
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Saint Clair Shores, Michigan, 48081, United States
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Minneapolis, Minnesota, 55446, United States
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Jefferson City, Missouri, 65109, United States
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Kansas City, Missouri, 64114, United States
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St Louis, Missouri, 63110, United States
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St Louis, Missouri, 63131, United States
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Missoula, Montana, 59808, United States
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Lincoln, Nebraska, 68516, United States
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Las Vegas, Nevada, 89119, United States
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Portsmouth, New Hampshire, 03801, United States
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Hackensack, New Jersey, 07601, United States
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Albuquerque, New Mexico, 87109, United States
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Buffalo, New York, 14202, United States
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Ridgewood, New York, 11385, United States
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Rochester, New York, 14607, United States
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Rochester, New York, 14642, United States
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Charlotte, North Carolina, 28208, United States
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Durham, North Carolina, 27710, United States
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Monroe, North Carolina, 28112, United States
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Morehead City, North Carolina, 28557, United States
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Wilmington, North Carolina, 28403, United States
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Cincinnati, Ohio, 45267, United States
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Westlake, Ohio, 44145, United States
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Allentown, Pennsylvania, 18103, United States
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Duncansville, Pennsylvania, 16635, United States
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Harrisburg, Pennsylvania, 17110, United States
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Philadelphia, Pennsylvania, 19104, United States
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Philadelphia, Pennsylvania, 19107, United States
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Pittsburgh, Pennsylvania, 15232, United States
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Providence, Rhode Island, 02903, United States
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Myrtle Beach, South Carolina, 29572, United States
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North Charleston, South Carolina, 29405, United States
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Rock Hill, South Carolina, 29732, United States
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Spartanburg, South Carolina, 29303, United States
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Knoxville, Tennessee, 37909, United States
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Austin, Texas, 78745, United States
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Dallas, Texas, 75246, United States
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El Paso, Texas, 79925, United States
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Houston, Texas, 77054, United States
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Houston, Texas, 77065, United States
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Houston, Texas, 77070, United States
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Houston, Texas, 77081, United States
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Houston, Texas, 77089, United States
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Kingwood, Texas, 77339, United States
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Mesquite, Texas, 75150, United States
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San Angelo, Texas, 76904, United States
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San Antonio, Texas, 78229, United States
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Shenandoah, Texas, 77384, United States
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Layton, Utah, 84041, United States
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Salt Lake City, Utah, 84115, United States
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Annandale, Virginia, 22003, United States
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Norfolk, Virginia, 23502, United States
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Norfolk, Virginia, 23507, United States
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Olympia, Washington, 98506, United States
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Seattle, Washington, 98109, United States
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Madison, Wisconsin, 53715, United States
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Melbourne, 3000, Australia
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Melbourne, 3004, Australia
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Murdoch, 6150, Australia
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Parkville, 3050, Australia
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Raymond Terrace, 4101, Australia
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Sippy Downs, 4556, Australia
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West Perth, 6005, Australia
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Alken, 3570, Belgium
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Liège, 4000, Belgium
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Montreal, Quebec, H2X 0A9, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Aalborg, 9100, Denmark
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Aarhus, 8200, Denmark
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Hvidovre, 2650, Denmark
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Roskilde, 4000, Denmark
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Svendborg, DK-5700, Denmark
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Dijon, 21079, France
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La Roche-sur-Yon, 85925, France
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Lille, 59037, France
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Nantes, 44093, France
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Nîmes, 30029, France
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Paris, 75014, France
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Paris, 75475, France
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Poitiers, 86000, France
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Saint-Etienne, 42055, France
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Strasbourg, 67091, France
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Toulouse, 31059, France
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Tours, 37000, France
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Cologne, 50924, Germany
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Essen, 45147, Germany
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Hamburg, 20095, Germany
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Hanover, 30625, Germany
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Mainz, 55131, Germany
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Petah Tikva, 49100, Israel
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Ramat Gan, 52621, Israel
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Kuala Lumpur, 56000, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Kuching, 93586, Malaysia
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Seberang Jaya, 13700, Malaysia
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Sunway City, 47500, Malaysia
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Krakow, 30-727, Poland
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Skórzewo, 60-185, Poland
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Singapore, 117599, Singapore
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Singapore, 169608, Singapore
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Singapore, 308442, Singapore
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Gyeonggi-do, 13620, South Korea
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Seoul, 03080, South Korea
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Seoul, 08308, South Korea
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Seoul, 5505, South Korea
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Badalona, 08916, Spain
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Barcelona, 08035, Spain
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Barcelona, 08036, Spain
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Barcelona, 08041, Spain
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Córdoba, 14004, Spain
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Madrid, 28007, Spain
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Madrid, 28031, Spain
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Madrid, 28040, Spain
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Marbella (Málaga), 29603, Spain
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Mérida, 06800, Spain
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Pozuelo de Alarcón, 28223, Spain
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Valladolid, 47003, Spain
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Vigo, 36312, Spain
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Taichung, 40447, Taiwan
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Taipei, 11490, Taiwan
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Bangkok, 10400, Thailand
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Bangkok, 10700, Thailand
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Khon Kaen, 40002, Thailand
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Muang, 11000, Thailand
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Muang, 50200, Thailand
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Abu Dhabi, 2951, United Arab Emirates
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Abu Dhabi, 34555, United Arab Emirates
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Bristol, BS2 8DX, United Kingdom
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Edinburgh, EH4 2XU, United Kingdom
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Harrow, HA1 3UJ, United Kingdom
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Leeds, LS9 7TF, United Kingdom
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Liverpool, L7 8XP, United Kingdom
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London, SE1 7EH, United Kingdom
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London, W1T 7HA, United Kingdom
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Manchester, M8 5RB, United Kingdom
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Oxford, OX3 7LA, United Kingdom
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Sheffield, S10 2JF, United Kingdom
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Torpoint, PL11 2TB, United Kingdom
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Truro, TR1 3LJ, United Kingdom
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Hanoi, 100000, Vietnam
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Hochiminh City, 700000, Vietnam
Related Publications (26)
Alhumaid S, Al Mutair A, Al Alawi Z, Rabaan AA, Tirupathi R, Alomari MA, Alshakhes AS, Alshawi AM, Ahmed GY, Almusabeh HM, Alghareeb TT, Alghuwainem AA, Alsulaiman ZA, Alabdulmuhsin MA, AlBuwaidi EA, Dukhi AKB, Mufti HN, Al-Qahtani M, Dhama K, Al-Tawfiq JA, Al-Omari A. Anaphylactic and nonanaphylactic reactions to SARS-CoV-2 vaccines: a systematic review and meta-analysis. Allergy Asthma Clin Immunol. 2021 Oct 16;17(1):109. doi: 10.1186/s13223-021-00613-7.
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PMID: 38924429DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- For the Sentinel Safety Cohort and Main Cohort, neither the participant nor any of the Investigators or Sponsor staff who are involved in the treatment or clinical evaluation and monitoring of the participants will be aware of the study intervention received. Since AZD5156, AZD3152, and placebo are visually distinct prior to dose preparation (due to differences in vial volumes and container closure), study intervention will be handled by an unblinded pharmacist and administered by an unblinded administrator (or designee, in accordance with local and institutional regulations) at the study site who will be independent of safety evaluations and other trial evaluations. Personnel preparing and administering study intervention may be the same individual. Syringe masking will be required in order to maintain the blind.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2022
First Posted
December 13, 2022
Study Start
December 16, 2022
Primary Completion
March 29, 2024
Study Completion
February 11, 2025
Last Updated
March 13, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- 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.
- Access Criteria
- 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.
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.