Coronavirus Disease 2019 (COVID-19)COVID-19NCT04877743
Non-Interventional Enhanced Active Surveillance Study of Adults Vaccinated With AZD1222
An observational study of Coronavirus Disease 2019 (COVID-19), run by AstraZeneca at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 130 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Disease 2019 (COVID-19)
- What is being tested?
- None (Observational study)
- Type of treatment
- Vaccines
- How many people
- 27 participants
- Where
- 1 siteGermany
- Study dates
- 31 May 2021to 24 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IV Non-Interventional Enhanced Active Surveillance Study of Adults Vaccinated With AZD1222
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.
Read the 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.
- Conditions
- Coronavirus Disease 2019 (COVID-19)
- Being tested
- None (Observational study)
- Keywords
- Active Surveillance Study, Non-interventional, Post-authorisation safety studies, Vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: None (Observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start31 May 2021
- Primary completion24 Nov 2021
- Study completion24 Nov 2021
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus Disease 2019 (COVID-19)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877743
- Sponsor's protocol ID
- D8111R00003
- Acronym
- COVID-19
- Status last verified
- Jun 2022
- First submitted
- 4 May 2021
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Non-Interventional Enhanced Active Surveillance Study of Adults Vaccinated With AZD1222
- ClinicalTrials.gov ID
- NCT04877743
- Acronym / sponsor ID
- COVID-19 / D8111R00003
- Conditions
- Coronavirus Disease 2019 (COVID-19)
- Keywords
- Active Surveillance Study, Non-interventional, Post-authorisation safety studies, Vaccine
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 27 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 31 May 2021 (actual)
- Primary completion
- 24 Nov 2021 (actual)
- Study completion
- 24 Nov 2021 (actual)
- First posted
- 7 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective Cohort | – | Other: None (Observational study)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. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None (Observational study)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. | Other | Prospective Cohort |
Primary outcome
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
Time frame: Up to 3 months
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.
8 secondary outcomes
Number of participants with SAEs, AESIs and medically-attended AEFIs with AZD1222 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
Time frame: Up to 18 months
Number of participants with select comorbidities with SAEs, AESIs and medically-attended AEFIs with AZD1222
Time frame: Up to 18 months
Prevalence of pregnancies resulting in spontaneous abortions within the AESI medical concept of Pregnancy Outcomes - Maternal
Time frame: Up to 12 months
Prevalence of pregnancies resulting in stillbirths within the AESI medical concept of Pregnancy Outcomes - Maternal
Time frame: Up to 12 months
Prevalence of pregnancies resulting in preterm births within the AESI medical concept of Pregnancy Outcomes - Maternal
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
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
Time frame: Up to 12 months
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Disease 2019 (COVID-19), run by AstraZeneca at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022; AzTrials last refreshed its copy on 7 Nov 2026.