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Trial record 1 of 33 for:    AZD1222
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EU Secondary Data Post-Authorisation Safety Study of AZD1222 (D8111R00006)

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ClinicalTrials.gov Identifier: NCT05126992
Recruitment Status : Not yet recruiting
First Posted : November 19, 2021
Last Update Posted : December 16, 2021
Sponsor:
Collaborator:
RTI Health Solutions
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:

A study based on electronic heath records will evaluate the incidence and relative risk of safety concerns and adverse events of special interest (AESIs) following immunisation by AZD1222 in the real-world setting.

A cohort and a self-controlled case series desings will be used.


Condition or disease Intervention/treatment
COVID-19, Vaccine Adverse Events of Special Interest Biological: AZD1222

Detailed Description:
This retrospective study based on electronic heath records will evaluate the incidence and relative risk of safety concerns and adverse events of special interest (AESIs) following immunisation by AZD1222 in the real-world setting. The primary study objectives are to (1) describe baseline characteristics of all individuals who receive at least one dose of AZD1222 over the study period; (2) describe, among subjects who receive a first dose of AZD1222, the timing and type of second dose of any COVID-19 vaccine over the study period; (3) describe the incidence of prespecified AESIs in subjects who have received at least one dose of AZD1222 and in matched unvaccinated subjects; and (4) estimate any increased risk of prespecified AESIs following vaccination with AZD1222 using study retrospective cohort and self-controlled risk interval designs. Secondary objectives are identical to the primary, although focused on specific populations considered to have missing information, specifically (a) women who are pregnant or breastfeeding, (b) immunocompromised patients, (b) frail patients with certain comorbidities, (c) patients with autoimmune or inflammatory disorders, and (d) patients who, at cohort entry, had recently received a number of selected vaccines to prevent diseases other than COVID-19. A cohort and a self-controlled case series desings will be used.

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Study Type : Observational
Estimated Enrollment : 5200000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Post-authorisation/Post-marketing Observational Study to Evaluate the Association Between Exposure to AZD1222 and Safety Concerns Using Existing Secondary Health Data Sources
Estimated Study Start Date : January 12, 2022
Estimated Primary Completion Date : April 15, 2023
Estimated Study Completion Date : April 15, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: AZD-1222

Group/Cohort Intervention/treatment
AZD1222
at least one dose of AZD1222
Biological: AZD1222
Covid-19 AstraZeneca Vaccine

comparator
non vaccinated



Primary Outcome Measures :
  1. Adverse events of special interest [ Time Frame: up to 365 days ]
    several AESIs



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
The study population will include subjects who are exposed to the AZD1222 vaccine and concurrent subjects who have not received any SARS-CoV-2 vaccine, who will serve as comparators.
Criteria

Inclusion Criteria:

  • Have at least 12 months of data available before cohort entry
  • Have no record of vaccination with any SARS-CoV-2 vaccine on or before the date of cohort entry

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05126992


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

Locations
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Italy
Research Site
Firenze, Italy, 50141
Netherlands
Research Site
Utrecht, Netherlands, 3528 AE
Spain
Research Site
Barcelona, Spain, 08007
Research Site
Valencia, Spain, 46020
Sponsors and Collaborators
AstraZeneca
RTI Health Solutions
Study Data/Documents: URL  This link exits the ClinicalTrials.gov site
Identifier: EUPAS Register
EUPAS Register

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT05126992    
Other Study ID Numbers: D8111R00006
First Posted: November 19, 2021    Key Record Dates
Last Update Posted: December 16, 2021
Last Verified: December 2021
Keywords provided by AstraZeneca:
AZD1222
ChAdOx1nCoV-19
Vaccine Adverse Events of Special Interest
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases