Non-Interventional Enhanced Active Surveillance Study of Adults Vaccinated With AZD1222

NCT04877743 | Terminated

• 1 other identifier: D8111R00003
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase IV real-world, observational, non-interventional, prospective cohort study of adults vaccinated with AZD1222. The purpose of this study is to assess the safety and tolerability of AZD1222 in adults vaccinated in real-world settings.

Conditions

Coronavirus Disease 2019 (COVID-19)

Keywords

Active Surveillance Study; Non-interventional; Post-authorisation safety studies; Vaccine

Outcome Measures

Primary Outcomes (1)

• Number of participants with serious adverse events (SAEs), adverse events of special interest (AESIs) and medically-attended adverse events following immunisation (AEFIs) with AZD1222 for 3 months after vaccination

  The incidence of SAEs, AESIs, and medically-attended AEFIs after at least one intramuscular (IM) dose of AZD1222 will be estimated for 3 months after vaccination.

  Up to 3 months

Secondary Outcomes (8)

• Number of participants with SAEs, AESIs and medically-attended AEFIs with AZD1222 for up to 18 months after vaccination

  Up to 18 months

• Number of participants with SAEs, AESIs and medically-attended AEFIs with AZD1222 categorised by age group

  Up to 18 months

• Number of participants with select comorbidities with SAEs, AESIs and medically-attended AEFIs with AZD1222

  Up to 18 months

• Prevalence of pregnancies resulting in spontaneous abortions within the AESI medical concept of Pregnancy Outcomes - Maternal

  Up to 12 months

• Prevalence of pregnancies resulting in stillbirths within the AESI medical concept of Pregnancy Outcomes - Maternal

  Up to 12 months

Study Arms (1)

Prospective Cohort

This prospective cohort study will include participants who receive the AZD1222 vaccine. Enrolment is permitted within 28 days of the first dose of AZD1222 and can be completed at the vaccination site or remotely.

Other: None (Observational study)

Interventions

None (Observational study) OTHER

The main data sources for the study will be participants and their medical records. Vaccination details will be verified by a vaccination card, batch/lot number, and/or using a regional vaccination register. Participants will report all study outcomes using the study app, web portal, or call centre. Participants can also select a proxy to communicate on their behalf: a caregiver, family member, or other trusted individual. Participants will be asked for an emergency contact in case of death or incapacity.

Prospective Cohort

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be adults ≥ 18 years of age who receive the AZD1222 vaccine in Germany, France, Spain, or Sweden and are able and willing to consent to participate in the study. This study will enrol all eligible participants but, in particular, will seek to enrol older adults, with a target of 50% of participants being aged ≥ 65 years. Other subpopulations of interest include pregnant women, women who are breastfeeding, immunocompromised persons, persons with an autoimmune or inflammatory disorder, and frail persons with comorbidities. The study will also aim for an approximately equal enrolment of male and female participants.

You may qualify if:

• Aged 18 or older at the time of vaccination.
• Received AZD1222 as the first dose of COVID-19 vaccination in the prior 28 days.
• The participant has provided sufficient details to validate the vaccination (vaccination card, batch/lot number, and/or regional vaccination register details).
• Provided informed consent to participate in the study, either personally or through a legal representative.
• Able and willing to provide responses to study notifications using the mobile device app, web portal, or call centre or have a proxy (a caregiver, family member, or other trusted individual) who can do so on their behalf.
• Able and willing to grant, personally or through a legal representative, permission to contact the participant's healthcare providers and to access the participant's medical records at the time of vaccination and during the post-vaccination follow-up period.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Essen, 45355, Germany

Location

Related Links

• Related Info

MeSH Terms

Conditions

COVID-19

Interventions

Observation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 7, 2021
• Study Start: May 31, 2021
• Primary Completion: November 24, 2021
• Study Completion: November 24, 2021
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• 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 de-identified 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.

Locations

DE (1)