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The AZ:CONNECTEU study will be stopped. Ongoing participants will be informed and off-boarded. Vaxzevria's safety continues to be monitored through the implementation of other studies and through established safety reporting platforms across Europe.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 18 months |
| Number of participants with SAEs, AESIs and medically-attended AEFIs with AZD1222 categorised by age group |
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Inclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Essen | 45355 | Germany |
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| Label | URL |
|---|---|
| Related Info | View source |
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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
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.
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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|
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. |
| 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. | 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. | Up to 12 months |
| Prevalence of pregnancies resulting in stillbirths 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. | 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. | 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. | 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. | Up to 12 months |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |