Clinical trial NCT04877743: Non-Interventional Enhanced Active Surveillance Study of Adults Vaccinated With AZD1222
Official title: A Phase IV Non-Interventional Enhanced Active Surveillance Study of Adults Vaccinated With AZD1222
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Coronavirus Disease 2019 (COVID-19)
Keywords: Active Surveillance Study
Non-interventional
Post-authorisation safety studies
Vaccine
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2021-05-07
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: The study will use an innovative digital platform (study app and web portal) as well as a traditional call centre to collect participant responses to a series of health and well-being questionnaires over an 18-month period.

Research coordinators at vaccination sites will invite vaccinated adults to join the study. Participants can enrol at the vaccination site with assistance from a research coordinator or can take home a study information brochure and enrol within 28 days after the first dose of AZD1222. Research coordinators and the study call centre will be available to assist with enrolment and informed consent, as needed. Electronic consent using the study app will be an option where permitted.

Participants using the digital platform will set up a secure account, complete the enrolment questionnaires, and provide details of their vaccination to confirm eligibility. Non-digital participants will complete the enrolment questionnaires and confirm eligibility at a vaccination site or by a telephone call to the call centre. After enrolment, participants will be contacted to complete follow-up questionnaires at timed intervals over an 18-month period after their first AZD1222 dose. Digital participants will receive push notifications or emails and non-digital participants will receive phone calls. Participants can also submit unscheduled adverse event (AE) reports through the digital platform and call centre.

Eligibility criteria: Inclusion Criteria:

* 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.

Primary outcomes:
measure: 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
timeFrame: Up to 3 months
Secondary outcomes:
measure: Number of participants with SAEs, AESIs and medically-attended AEFIs with AZD1222 for up to 18 months after vaccination
timeFrame: Up to 18 months
measure: Number of participants with SAEs, AESIs and medically-attended AEFIs with AZD1222 categorised by age group
timeFrame: Up to 18 months
measure: Number of participants with select comorbidities with SAEs, AESIs and medically-attended AEFIs with AZD1222
timeFrame: Up to 18 months
measure: Prevalence of pregnancies resulting in spontaneous abortions within the AESI medical concept of Pregnancy Outcomes - Maternal
timeFrame: Up to 12 months
measure: Prevalence of pregnancies resulting in stillbirths within the AESI medical concept of Pregnancy Outcomes - Maternal
timeFrame: Up to 12 months
measure: Prevalence of pregnancies resulting in preterm births within the AESI medical concept of Pregnancy Outcomes - Maternal
timeFrame: Up to 12 months
measure: Prevalence of major congenital malformations in the AESI medical concept of Pregnancy Outcomes - Neonates as a measure of infant outcome
timeFrame: Up to 12 months
measure: Prevalence of small for gestational age in the AESI medical concept of Pregnancy Outcomes - Neonates as a measure of infant outcome
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Research Site
Study officials:
References: