Phase III Double-blind, Placebo-controlled Study of AZD1222 for the Prevention of COVID-19 in Adults

Recruitment Status:
Active, not recruiting

Sponsor:
AstraZeneca

Collaborator:
IQVIA

Information Provided by (Responsible Party):
AstraZeneca

ClinicalTrials.gov Identifier:
NCT04516746

Verification:
Verified 01 April 2021   by AstraZeneca

History of Changes:
ClinicalTrials.gov

Purpose

The aim of the study is to assess the safety, efficacy, and immunogenicity of AZD1222 for the prevention of COVID-19.

Official Title:A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study in Adults, to Determine the Safety, Efficacy, and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19
Study Type:Interventional
Overall Recruitment Status:Active, not recruiting
Study Start Date:28 August 2020
Study Start Date Type:Actual
Primary Completion Date:05 March 2021
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking Description: Double Blind: two or more parties are unaware of the intervention assignment.
Model Description: Participants are assigned to one of two or more groups in parallel for the duration of the study.
ConditionInterventionPhase
COVID-19
SARS-CoV-2
Biological/Vaccine: AZD1222
Biological/Vaccine: Placebo
Phase 3
Ages Eligible for Study: 18 Years  to 130 Years
Genders Eligible for Study: Both
Gender Based: No
Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:
• Increased risk of SARS-CoV-2 infection
• Medically stable

Exclusion Criteria:
• confirmed or suspected immunosuppressive or immunodeficient state
• significant disease, disorder, or finding
• Prior or concomitant vaccine therapy for COVID-19


Contacts

Contact: AstraZeneca Clinical  Study Information Center   1-877-240-9479    information.center@astrazeneca.com  

Sponsors and Collaborators

AstraZeneca
IQVIA

Investigators

Principal Investigator: Ann  Falsey , MD   University of Rochester School of Medicine
Principal Investigator: Magda  Sobieszczyk , MD   Columbia University

Locations

CountryLocationFacilityContactStatus
United States of America , TXResearch Site Austin, TX, United States of America, 78745Recruiting
United States of America , TXResearch Site Dallas, TX, United States of America, 75208Recruiting
United States of America , TXResearch Site Houston, TX, United States of America, 77030Recruiting
United States of America , TXResearch Site McAllen, TX, United States of America, 78504Recruiting
United States of America , TXResearch Site San Antonio, TX, United States of America, 78229Withdrawn
United States of America , TXResearch Site San Antonio, TX, United States of America, 78236Active, not recruiting
United States of America , TXResearch Site The Woodlands, TX, United States of America, 77381Recruiting
United States of America , NYResearch Site Bronx, NY, United States of America, 10467Active, not recruiting
United States of America , NYResearch Site Bronx, NY, United States of America, 10457Active, not recruiting
United States of America , NYResearch Site Brooklyn, NY, United States of America, 11220Active, not recruiting
United States of America , NYResearch Site Mineola, NY, United States of America, 11501Active, not recruiting
United States of America , NYResearch Site New York, NY, United States of America, 10032Recruiting
United States of America , NYResearch Site New York, NY, United States of America, 10016Recruiting
United States of America , NYResearch Site New York, NY, United States of America, 10032Recruiting
United States of America , NYResearch Site New York, NY, United States of America, 10016Active, not recruiting
United States of America , NYResearch Site New York, NY, United States of America, 10010Active, not recruiting
United States of America , NYResearch Site Rochester, NY, United States of America, 14621Active, not recruiting
United States of America , NYResearch Site Rochester, NY, United States of America, 14642Recruiting
United States of America , NYResearch Site Rochester, NY, United States of America, 14621Active, not recruiting
United States of America , NYResearch Site Valhalla, NY, United States of America, 10595Recruiting
United States of America , SCResearch Site Charleston, SC, United States of America, 29406Recruiting
United States of America , SCResearch Site Charleston, SC, United States of America, 29425Recruiting
United States of America , SCResearch Site Spartanburg, SC, United States of America, 29303Recruiting
United States of America , INResearch Site Indianapolis, IN, United States of America, 46202Recruiting
United States of America , CAResearch Site Berkeley, CA, United States of America, 94705Recruiting
United States of America , CAResearch Site El Centro, CA, United States of America, 92243Active, not recruiting
United States of America , CAResearch Site Los Angeles, CA, United States of America, 90095Recruiting
United States of America , CAResearch Site Los Angeles, CA, United States of America, 90033Recruiting
United States of America , CAResearch Site San Diego, CA, United States of America, 92134Active, not recruiting
United States of America , CAResearch Site San Diego, CA, United States of America, 92103Recruiting
United States of America , CAResearch Site San Francisco, CA, United States of America, 94102Recruiting
United States of America , CAResearch Site San Francisco, CA, United States of America, 94158Recruiting
United States of America , CAResearch Site Torrance, CA, United States of America, 90502Recruiting
United States of America , FLResearch Site Atlantis, FL, United States of America, 33462Recruiting
United States of America , FLResearch Site Coral Gables, FL, United States of America, 33134Recruiting
United States of America , FLResearch Site Miami Lakes, FL, United States of America, 33016Recruiting
United States of America , FLResearch Site Orlando, FL, United States of America, 32803Recruiting
United States of America , HIResearch Site Honolulu, HI, United States of America, 96814Recruiting
United States of America , OHResearch Site Cincinnati, OH, United States of America, 45229Recruiting
United States of America , OHResearch Site Columbus, OH, United States of America, 43205Recruiting
United States of America , OHResearch Site Columbus, OH, United States of America, 43210Recruiting
United States of America , RIResearch Site Warwick, RI, United States of America, 02886Recruiting
United States of America , ALResearch Site Birmingham, AL, United States of America, 35294Active, not recruiting
United States of America , LAResearch Site Lake Charles, LA, United States of America, 70601Recruiting
United States of America , LAResearch Site Monroe, LA, United States of America, 71201Recruiting
United States of America , NJResearch Site Berlin, NJ, United States of America, 08009Recruiting
United States of America , WIResearch Site Madison, WI, United States of America, 53792-5666Recruiting
United States of America , VTResearch Site Burlington, VT, United States of America, 05401Recruiting
United States of America , NVResearch Site Henderson, NV, United States of America, 89014Recruiting
United States of America , MAResearch Site Boston, MA, United States of America, 02215Recruiting
United States of America , MAResearch Site Boston, MA, United States of America, 02111Recruiting
United States of America , NHResearch Site Portsmouth, NH, United States of America, 03801Recruiting
United States of America , MNResearch Site Bloomington, MN, United States of America, 55425Recruiting
United States of America , WAResearch Site Seattle, WA, United States of America, 98109Recruiting
United States of America , WAResearch Site Seattle, WA, United States of America, 98104Recruiting
United States of America , KSResearch Site Fairway, KS, United States of America, 66205Active, not recruiting
United States of America , KSResearch Site Kansas City, KS, United States of America, 66160Recruiting
United States of America , KSResearch Site Wichita, KS, United States of America, 67207Recruiting
United States of America , KSResearch Site Wichita, KS, United States of America, 67214Active, not recruiting
United States of America , ILResearch Site Chicago, IL, United States of America, 60612Recruiting
United States of America , ILResearch Site Chicago, IL, United States of America, 60612Recruiting
United States of America , ILResearch Site Chicago, IL, United States of America, 60611Withdrawn
United States of America , UTResearch Site West Jordan, UT, United States of America, 84088Recruiting
United States of America , MTResearch Site Butte, MT, United States of America, 59701Recruiting
United States of America , MDResearch Site Baltimore, MD, United States of America, 21205Recruiting
United States of America , MDResearch Site Baltimore, MD, United States of America, 21201Active, not recruiting
United States of America , MDResearch Site Bethesda, MD, United States of America, 20889Active, not recruiting
United States of America , TexasResearch Site San Antonio, Texas, United States of America, 78234Active, not recruiting
United States of America , AZResearch Site Phoenix, AZ, United States of America, 85018Recruiting
United States of America , AZResearch Site Scottsdale, AZ, United States of America, 85258Recruiting
United States of America , ORResearch Site Portland, OR, United States of America, 97239Active, not recruiting
United States of America , MIResearch Site Ann Arbor, MI, United States of America, 48109Recruiting
United States of America , MIResearch Site Royal Oak, MI, United States of America, 48073Recruiting
United States of America , IAResearch Site Ankeny, IA, United States of America, 50023Recruiting
United States of America , NDResearch Site Fargo, ND, United States of America, 58103Not Yet Recruiting
United States of America , OKResearch Site Yukon, OK, United States of America, 73099Recruiting
United States of America , PAResearch Site Pittsburgh, PA, United States of America, 15232Recruiting
United States of America , GAResearch Site Stockbridge, GA, United States of America, 30281Suspended
United States of America , NCResearch Site Durham, NC, United States of America, 27710Active, not recruiting
United States of America , ARResearch Site Little Rock, AR, United States of America, 72212Active, not recruiting
United States of America , KYResearch Site Lexington, KY, United States of America, 40509Active, not recruiting
United States of America , WVResearch Site South Charleston, WV, United States of America, 25309Recruiting
United States of America , MEResearch Site Portland, ME, United States of America, 04102Active, not recruiting
United States of America , MSResearch Site Gulfport, MS, United States of America, 39503Recruiting
United States of America , MOResearch Site St. Louis, MO, United States of America, 63110Active, not recruiting
United States of America , TNResearch Site Knoxville, TN, United States of America, 37920Recruiting
United States of America , TNResearch Site Nashville, TN, United States of America, 37203Recruiting
United States of America , VAResearch Site Fort Belvoir, VA, United States of America, 22060Active, not recruiting
United States of America , VAResearch Site Richmond, VA, United States of America, 23226Recruiting
United States of America , NMResearch Site Albuquerque, NM, United States of America, 87102Recruiting
United States of America , COResearch Site Denver, CO, United States of America, 80204Recruiting
United States of America , CTResearch Site Danbury, CT, United States of America, 06810Not Yet Recruiting
United States of America , IDResearch Site Meridian, ID, United States of America, 83642Active, not recruiting
ChileResearch Site Quillota, Chile, 2260000Recruiting
ChileResearch Site Region Metropolitana, Chile, 7550000Not Yet Recruiting
ChileResearch Site Santiago, Chile, 7500539Not Yet Recruiting
ChileResearch Site Santiago, Chile, 8380453Recruiting
PeruResearch Site Callao, Peru, 0Recruiting
PeruResearch Site Cercado de Lima, Peru, LIMA 1Recruiting
PeruResearch Site Cercardo de Lima, Peru, LIMA 1Not Yet Recruiting
PeruResearch Site Lima, Peru, Lima32Not Yet Recruiting
PeruResearch Site Lima, Peru, Lima04Not Yet Recruiting
PeruResearch Site Lima, Peru, Lima12Not Yet Recruiting
PeruResearch Site Lima, Peru, 7006Recruiting
PeruResearch Site Lima, Peru, Lami 01Not Yet Recruiting
PeruResearch Site Lima, Peru, 33Active, not recruiting
PeruResearch Site Lima, Peru, 15001Not Yet Recruiting
PeruResearch Site Lima, Peru, Lima 27Recruiting
ColombiaResearch Site Barranquilla, Colombia, 080020Not Yet Recruiting
ColombiaResearch Site Bogota, Colombia, 110221Not Yet Recruiting
ColombiaResearch Site Floridablanca, Colombia, 681004Not Yet Recruiting
ColombiaResearch Site Manizales, Colombia, 17001Not Yet Recruiting
ColombiaResearch Site Medellin, Colombia, 50034Not Yet Recruiting
ArgentinaResearch Site Caba, Argentina, C1128AAFNot Yet Recruiting
ArgentinaResearch Site Ciudad Autónoma de Bs. As., Argentina, C1199ABBNot Yet Recruiting
ArgentinaResearch Site Ciudad Autónoma de Buenos Aire, Argentina, C1426 BORNot Yet Recruiting
FranceResearch Site Angers, France, 49033Not Yet Recruiting
FranceResearch Site Bron, France, 69677Not Yet Recruiting
FranceResearch Site Creteil, France, 94010Not Yet Recruiting
FranceResearch Site Dijon Cedex, France, 21079Not Yet Recruiting
FranceResearch Site Lille, France, 59000Not Yet Recruiting
FranceResearch Site Limoges cedex, France, 87000Not Yet Recruiting
FranceResearch Site Marseille, France, 13005Not Yet Recruiting
FranceResearch Site Paris, France, 75018Not Yet Recruiting
FranceResearch Site Paris, France, 75015Not Yet Recruiting
FranceResearch Site St Etienne, France, 42270Not Yet Recruiting

 File nameDescription
D8110C00001-csp-amendment-6_Redacted.pdfD8110C00001-csp-amendment-6_Redacted.pdf
.

Purpose

The aim of the study is to assess the safety, efficacy, and immunogenicity of AZD1222 for the prevention of COVID-19.

Official Title:A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study in Adults, to Determine the Safety, Efficacy, and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19
Study Type:Interventional
Overall Recruitment Status:Active, not recruiting
Study Start Date:28 August 2020
Study Start Date Type:Actual
Primary Completion Date:05 March 2021
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking Description: Double Blind: two or more parties are unaware of the intervention assignment.
Model Description: Participants are assigned to one of two or more groups in parallel for the duration of the study.
ConditionInterventionPhase
COVID-19
SARS-CoV-2
Biological/Vaccine: AZD1222
Biological/Vaccine: Placebo
Phase 3
Ages Eligible for Study: 18 Years  to 130 Years
Genders Eligible for Study: Both
Gender Based: No
Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:
• Increased risk of SARS-CoV-2 infection
• Medically stable

Exclusion Criteria:
• confirmed or suspected immunosuppressive or immunodeficient state
• significant disease, disorder, or finding
• Prior or concomitant vaccine therapy for COVID-19


Contacts

Contact: AstraZeneca Clinical  Study Information Center   1-877-240-9479    information.center@astrazeneca.com  

Sponsors and Collaborators

AstraZeneca
IQVIA

Investigators

Principal Investigator: Ann  Falsey , MD   University of Rochester School of Medicine
Principal Investigator: Magda  Sobieszczyk , MD   Columbia University

Locations

CountryLocationFacilityContactStatus
United States of America , TXResearch Site Austin, TX, United States of America, 78745Recruiting
United States of America , TXResearch Site Dallas, TX, United States of America, 75208Recruiting
United States of America , TXResearch Site Houston, TX, United States of America, 77030Recruiting
United States of America , TXResearch Site McAllen, TX, United States of America, 78504Recruiting
United States of America , TXResearch Site San Antonio, TX, United States of America, 78229Withdrawn
United States of America , TXResearch Site San Antonio, TX, United States of America, 78236Active, not recruiting
United States of America , TXResearch Site The Woodlands, TX, United States of America, 77381Recruiting
United States of America , NYResearch Site Bronx, NY, United States of America, 10467Active, not recruiting
United States of America , NYResearch Site Bronx, NY, United States of America, 10457Active, not recruiting
United States of America , NYResearch Site Brooklyn, NY, United States of America, 11220Active, not recruiting
United States of America , NYResearch Site Mineola, NY, United States of America, 11501Active, not recruiting
United States of America , NYResearch Site New York, NY, United States of America, 10032Recruiting
United States of America , NYResearch Site New York, NY, United States of America, 10016Recruiting
United States of America , NYResearch Site New York, NY, United States of America, 10032Recruiting
United States of America , NYResearch Site New York, NY, United States of America, 10016Active, not recruiting
United States of America , NYResearch Site New York, NY, United States of America, 10010Active, not recruiting
United States of America , NYResearch Site Rochester, NY, United States of America, 14621Active, not recruiting
United States of America , NYResearch Site Rochester, NY, United States of America, 14642Recruiting
United States of America , NYResearch Site Rochester, NY, United States of America, 14621Active, not recruiting
United States of America , NYResearch Site Valhalla, NY, United States of America, 10595Recruiting
United States of America , SCResearch Site Charleston, SC, United States of America, 29406Recruiting
United States of America , SCResearch Site Charleston, SC, United States of America, 29425Recruiting
United States of America , SCResearch Site Spartanburg, SC, United States of America, 29303Recruiting
United States of America , INResearch Site Indianapolis, IN, United States of America, 46202Recruiting
United States of America , CAResearch Site Berkeley, CA, United States of America, 94705Recruiting
United States of America , CAResearch Site El Centro, CA, United States of America, 92243Active, not recruiting
United States of America , CAResearch Site Los Angeles, CA, United States of America, 90095Recruiting
United States of America , CAResearch Site Los Angeles, CA, United States of America, 90033Recruiting
United States of America , CAResearch Site San Diego, CA, United States of America, 92134Active, not recruiting
United States of America , CAResearch Site San Diego, CA, United States of America, 92103Recruiting
United States of America , CAResearch Site San Francisco, CA, United States of America, 94102Recruiting
United States of America , CAResearch Site San Francisco, CA, United States of America, 94158Recruiting
United States of America , CAResearch Site Torrance, CA, United States of America, 90502Recruiting
United States of America , FLResearch Site Atlantis, FL, United States of America, 33462Recruiting
United States of America , FLResearch Site Coral Gables, FL, United States of America, 33134Recruiting
United States of America , FLResearch Site Miami Lakes, FL, United States of America, 33016Recruiting
United States of America , FLResearch Site Orlando, FL, United States of America, 32803Recruiting
United States of America , HIResearch Site Honolulu, HI, United States of America, 96814Recruiting
United States of America , OHResearch Site Cincinnati, OH, United States of America, 45229Recruiting
United States of America , OHResearch Site Columbus, OH, United States of America, 43205Recruiting
United States of America , OHResearch Site Columbus, OH, United States of America, 43210Recruiting
United States of America , RIResearch Site Warwick, RI, United States of America, 02886Recruiting
United States of America , ALResearch Site Birmingham, AL, United States of America, 35294Active, not recruiting
United States of America , LAResearch Site Lake Charles, LA, United States of America, 70601Recruiting
United States of America , LAResearch Site Monroe, LA, United States of America, 71201Recruiting
United States of America , NJResearch Site Berlin, NJ, United States of America, 08009Recruiting
United States of America , WIResearch Site Madison, WI, United States of America, 53792-5666Recruiting
United States of America , VTResearch Site Burlington, VT, United States of America, 05401Recruiting
United States of America , NVResearch Site Henderson, NV, United States of America, 89014Recruiting
United States of America , MAResearch Site Boston, MA, United States of America, 02215Recruiting
United States of America , MAResearch Site Boston, MA, United States of America, 02111Recruiting
United States of America , NHResearch Site Portsmouth, NH, United States of America, 03801Recruiting
United States of America , MNResearch Site Bloomington, MN, United States of America, 55425Recruiting
United States of America , WAResearch Site Seattle, WA, United States of America, 98109Recruiting
United States of America , WAResearch Site Seattle, WA, United States of America, 98104Recruiting
United States of America , KSResearch Site Fairway, KS, United States of America, 66205Active, not recruiting
United States of America , KSResearch Site Kansas City, KS, United States of America, 66160Recruiting
United States of America , KSResearch Site Wichita, KS, United States of America, 67207Recruiting
United States of America , KSResearch Site Wichita, KS, United States of America, 67214Active, not recruiting
United States of America , ILResearch Site Chicago, IL, United States of America, 60612Recruiting
United States of America , ILResearch Site Chicago, IL, United States of America, 60612Recruiting
United States of America , ILResearch Site Chicago, IL, United States of America, 60611Withdrawn
United States of America , UTResearch Site West Jordan, UT, United States of America, 84088Recruiting
United States of America , MTResearch Site Butte, MT, United States of America, 59701Recruiting
United States of America , MDResearch Site Baltimore, MD, United States of America, 21205Recruiting
United States of America , MDResearch Site Baltimore, MD, United States of America, 21201Active, not recruiting
United States of America , MDResearch Site Bethesda, MD, United States of America, 20889Active, not recruiting
United States of America , TexasResearch Site San Antonio, Texas, United States of America, 78234Active, not recruiting
United States of America , AZResearch Site Phoenix, AZ, United States of America, 85018Recruiting
United States of America , AZResearch Site Scottsdale, AZ, United States of America, 85258Recruiting
United States of America , ORResearch Site Portland, OR, United States of America, 97239Active, not recruiting
United States of America , MIResearch Site Ann Arbor, MI, United States of America, 48109Recruiting
United States of America , MIResearch Site Royal Oak, MI, United States of America, 48073Recruiting
United States of America , IAResearch Site Ankeny, IA, United States of America, 50023Recruiting
United States of America , NDResearch Site Fargo, ND, United States of America, 58103Not Yet Recruiting
United States of America , OKResearch Site Yukon, OK, United States of America, 73099Recruiting
United States of America , PAResearch Site Pittsburgh, PA, United States of America, 15232Recruiting
United States of America , GAResearch Site Stockbridge, GA, United States of America, 30281Suspended
United States of America , NCResearch Site Durham, NC, United States of America, 27710Active, not recruiting
United States of America , ARResearch Site Little Rock, AR, United States of America, 72212Active, not recruiting
United States of America , KYResearch Site Lexington, KY, United States of America, 40509Active, not recruiting
United States of America , WVResearch Site South Charleston, WV, United States of America, 25309Recruiting
United States of America , MEResearch Site Portland, ME, United States of America, 04102Active, not recruiting
United States of America , MSResearch Site Gulfport, MS, United States of America, 39503Recruiting
United States of America , MOResearch Site St. Louis, MO, United States of America, 63110Active, not recruiting
United States of America , TNResearch Site Knoxville, TN, United States of America, 37920Recruiting
United States of America , TNResearch Site Nashville, TN, United States of America, 37203Recruiting
United States of America , VAResearch Site Fort Belvoir, VA, United States of America, 22060Active, not recruiting
United States of America , VAResearch Site Richmond, VA, United States of America, 23226Recruiting
United States of America , NMResearch Site Albuquerque, NM, United States of America, 87102Recruiting
United States of America , COResearch Site Denver, CO, United States of America, 80204Recruiting
United States of America , CTResearch Site Danbury, CT, United States of America, 06810Not Yet Recruiting
United States of America , IDResearch Site Meridian, ID, United States of America, 83642Active, not recruiting
ChileResearch Site Quillota, Chile, 2260000Recruiting
ChileResearch Site Region Metropolitana, Chile, 7550000Not Yet Recruiting
ChileResearch Site Santiago, Chile, 7500539Not Yet Recruiting
ChileResearch Site Santiago, Chile, 8380453Recruiting
PeruResearch Site Callao, Peru, 0Recruiting
PeruResearch Site Cercado de Lima, Peru, LIMA 1Recruiting
PeruResearch Site Cercardo de Lima, Peru, LIMA 1Not Yet Recruiting
PeruResearch Site Lima, Peru, Lima32Not Yet Recruiting
PeruResearch Site Lima, Peru, Lima04Not Yet Recruiting
PeruResearch Site Lima, Peru, Lima12Not Yet Recruiting
PeruResearch Site Lima, Peru, 7006Recruiting
PeruResearch Site Lima, Peru, Lami 01Not Yet Recruiting
PeruResearch Site Lima, Peru, 33Active, not recruiting
PeruResearch Site Lima, Peru, 15001Not Yet Recruiting
PeruResearch Site Lima, Peru, Lima 27Recruiting
ColombiaResearch Site Barranquilla, Colombia, 080020Not Yet Recruiting
ColombiaResearch Site Bogota, Colombia, 110221Not Yet Recruiting
ColombiaResearch Site Floridablanca, Colombia, 681004Not Yet Recruiting
ColombiaResearch Site Manizales, Colombia, 17001Not Yet Recruiting
ColombiaResearch Site Medellin, Colombia, 50034Not Yet Recruiting
ArgentinaResearch Site Caba, Argentina, C1128AAFNot Yet Recruiting
ArgentinaResearch Site Ciudad Autónoma de Bs. As., Argentina, C1199ABBNot Yet Recruiting
ArgentinaResearch Site Ciudad Autónoma de Buenos Aire, Argentina, C1426 BORNot Yet Recruiting
FranceResearch Site Angers, France, 49033Not Yet Recruiting
FranceResearch Site Bron, France, 69677Not Yet Recruiting
FranceResearch Site Creteil, France, 94010Not Yet Recruiting
FranceResearch Site Dijon Cedex, France, 21079Not Yet Recruiting
FranceResearch Site Lille, France, 59000Not Yet Recruiting
FranceResearch Site Limoges cedex, France, 87000Not Yet Recruiting
FranceResearch Site Marseille, France, 13005Not Yet Recruiting
FranceResearch Site Paris, France, 75018Not Yet Recruiting
FranceResearch Site Paris, France, 75015Not Yet Recruiting
FranceResearch Site St Etienne, France, 42270Not Yet Recruiting

Oversight


Is FDA regulated intervention: No 
Is IND/IDE protocol: Yes 
IND/IDE Grantor: CBER 
IND/IDE Number: 23522 
Has Expanded Access: No 
U.S. FDA-regulated Drug: Yes 
U.S. FDA-regulated Device: No 

More Information


D8110C00001-csp-amendment-6_Redacted.pdf

Publications:


Responsible Party:AstraZeneca
ClinicalTrials.gov Identifier:NCT04516746
Other Study ID Numbers:D8110C00001

Keywords provided by AstraZeneca
COVID-19 Vaccine

Additional Relevant MeSH terms:
COVID-19SARS-CoV-2

Primary Outcome Measures:

  • The efficacy of 2 IM doses of AZD1222 compared to saline placebo for the prevention of COVID-19 [ Time Frame: 1 year ] [ Designated as safety issue:  ]
    A binary response, whereby a participant is
    defined as a COVID-19 case if their first case of
    SARS-CoV-2 RT-PCR-positive symptomatic illness occurs
    ≥ 15 days post second dose of study intervention. Otherwise, a participant is not defined as a COVID-19 case.

  • The safety and tolerability of 2 IM doses of AZD1222 compared to saline placebo [ Time Frame: a: 28 days post each dose of study Intervention. / b: from Day 1 post-treatment through Day 730. ] [ Designated as safety issue:  ]
    a. Incidence of adverse events.
    b. Incidence of serious adverse events, medically attended adverse events, and adverse events of special interest.

  • The reactogenicity of 2 IM doses of AZD1222 compared to saline placebo (Substudy only) [ Time Frame: 7 days post each dose of study intervention. ] [ Designated as safety issue:  ]
    Incidence of local and systemic solicited adverse events.

Secondary Outcome Measures:

  • The efficacy of 2 IM doses of AZD1222 compared tosaline placebo for the prevention of SARS-CoV-2 infection [ Time Frame: 1 year ] [ Designated as safety issue:  ]
    The incidence of the first post-treatment response (negative at baseline to positive post treatment with study intervention) for SARS-CoV-2 Nucleocapsid antibodies occurring greater than or equal to 15 days post second dose of study intervention.

  • The efficacy of 2 IM doses of AZD1222 compared to saline placebo for the prevention of symptomatic COVID-19 using CDC criteria [ Time Frame: 1 year ] [ Designated as safety issue:  ]
    The incidence of the first case of SARS-CoV-2 RT-PCR-positive symptomatic illness for a participant occurring at or after 15 days post second dose of study intervention using criteria from the CDC.

  • The efficacy of 2 IM doses of AZD1222 compared to saline placebo for the prevention of University of Oxford defined symptomatic COVID-19 [ Time Frame: 1 year ] [ Designated as safety issue:  ]
    The incidence of the first case of SARS-CoV-2 RT-PCR positive symptomatic illness occurring ≥ 15 days post second
    dose of study intervention using University of Oxford defined symptom criteria.

  • The efficacy of 2 IM doses of AZD12222 compared to saline placebo for the prevention of severe or critical symptomatic COVID-19. [ Time Frame: 1 year ] [ Designated as safety issue:  ]
    The incidence of SARS-CoV-RT-PCR-positive severe or critical symptomatic illness occurring 15 days or more post second dose of study intervention. The incidence of SARS-CoV-2 RT-PCR positive severe or critical symptomatic illness occurring post first dose of study intervention

  • The efficacy of 2 IM doses of AZD1222 compared to saline placebo for the prevention of COVID-19-related Emergency Department visits [ Time Frame: 1 year ] [ Designated as safety issue:  ]
    The incidence of COVID-19-related Emergency Department visits occurring ≥ 15 days post second dose of study intervention

  • Antibody responses to AZD1222 S antigen following 2 IM doses of AZD1222 or saline placebo (Substudy and Illness Visits only) [ Time Frame: 28 days post each dose ] [ Designated as safety issue:  ]
    Post-treatment GMTs and GMFRs in SARS-CoV-2 S, RBD antibodies (MSD serology assay); The proportion of participants who have a post-treatment seroresponse (≥ 4-fold rise in titers) to the S, RBD antigens of AZD1222 (MSD serology assay)

  • Anti-SARS-CoV-2 neutralizing antibody levels in serum following 2 IM doses of AZD1222 or saline placebo (Substudy and Illness Visits only) [ Time Frame: 28 days post each dose ] [ Designated as safety issue:  ]
    Post-treatment GMTs and GMFRs in SARS-CoV-2 neutralizing antibodies (wild-type assay or pseudo-neutralization assay); Proportion of participants who have a post-treatment seroresponse (≥ 4-fold rise in titers) to AZD1222 as measured by SARS-CoV-2 neutralizing antibodies (wild-type assay or pseudo-neutralization assay)

  • The efficacy of 2 IM doses of AZD1222 compared to saline placebo in the prevention of COVID-19 in all study participants, regardless of evidence of prior SARS-CoV-2 infection [ Time Frame: 1 year ] [ Designated as safety issue:  ]
    The incidence of the first case of SARS-CoV-2 RT-PCR-positive symptomatic illness occurring ≥ 15 days post second dose of study intervention regardless of evidence of prior SARS-CoV-2 infection

  • The efficacy of AZD1222 compared to saline placebo for the prevention of COVID-19 following the first dose [ Time Frame: 1 year ] [ Designated as safety issue:  ]
    The incidence of SARS-CoV-2 RT-PCR-positive symptomatic illness occurring post first dose of study intervention

Other Pre-specified Outcome Measures:

  • [ Time Frame:  ] [ Designated as safety issue:  ]

ArmsAssigned Interventions
Experimental: AZD1222
Approximately 20,000 participants randomized to the AZD1222 arm
Biological/Vaccine: AZD1222
AZD12222 is a recombinant replication-defective chimpanzee adenovirus expressing the SARS-CoV-2-5 surface glycoprotein.
 
Placebo Comparator: Placebo
Approximately 10,000 participants randomized to the saline placebo arm
Biological/Vaccine: Placebo
Commercially available 0.9% (n/V) saline for injection.