Coronavirus Disease 2019 (COVID-19) Clinical Trial
— COVID-19Official title:
A Phase IV Non-Interventional Enhanced Active Surveillance Study of Adults Vaccinated With AZD1222
NCT number | NCT04877743 |
Other study ID # | D8111R00003 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | May 31, 2021 |
Est. completion date | November 24, 2021 |
Verified date | June 2022 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 27 |
Est. completion date | November 24, 2021 |
Est. primary completion date | November 24, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 130 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Germany | Research Site | Essen |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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. | Up to 18 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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