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.
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.
Study Type
OBSERVATIONAL
Enrollment
27
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.
Research Site
Essen, Germany
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.
Time frame: Up to 3 months
Number of participants with SAEs, AESIs and medically-attended AEFIs with AZD1222 for up to 18 months after vaccination
The incidence of SAEs, AESIs, and medically-attended AEFIs after at least one IM dose of AZD1222 will be estimated for up to 18 months after vaccination.
Time frame: Up to 18 months
Number of participants with SAEs, AESIs and medically-attended AEFIs with AZD1222 categorised by age group
The incidence of SAEs, AESIs, and medically-attended AEFIs after at least one IM dose of AZD1222 will be estimated in participants by age group.
Time frame: Up to 18 months
Number of participants with select comorbidities with SAEs, AESIs and medically-attended AEFIs with AZD1222
The incidence of SAEs, AESIs, and medically-attended AEFIs after at least one IM dose of AZD1222 will be estimated in participants with select comorbidities.
Time frame: Up to 18 months
Prevalence of pregnancies resulting in spontaneous abortions within the AESI medical concept of Pregnancy Outcomes - Maternal
The frequency of select pregnancy outcomes will be estimated in women vaccinated with AZD1222 during pregnancy or within 45 days of the estimated conception date.
Time frame: Up to 12 months
Prevalence of pregnancies resulting in stillbirths within the AESI medical concept of Pregnancy Outcomes - Maternal
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The frequency of select pregnancy outcomes will be estimated in women vaccinated with AZD1222 during pregnancy or within 45 days of the estimated conception date.
Time frame: Up to 12 months
Prevalence of pregnancies resulting in preterm births within the AESI medical concept of Pregnancy Outcomes - Maternal
The frequency of select pregnancy outcomes will be estimated in women vaccinated with AZD1222 during pregnancy or within 45 days of the estimated conception date.
Time frame: Up to 12 months
Prevalence of major congenital malformations in the AESI medical concept of Pregnancy Outcomes - Neonates as a measure of infant outcome
The frequency of select outcomes will be estimated at birth and up to 12 months of age in neonates/infants born to mothers vaccinated with AZD1222 during pregnancy or within 45 days of the estimated conception date.
Time frame: Up to 12 months
Prevalence of small for gestational age in the AESI medical concept of Pregnancy Outcomes - Neonates as a measure of infant outcome
The frequency of select outcomes will be estimated at birth and up to 12 months of age in neonates/infants born to mothers vaccinated with AZD1222 during pregnancy or within 45 days of the estimated conception date.
Time frame: Up to 12 months