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In Japan, the government purchases VAXZEVRIA and distributes it to medical institutions. Based on Japan VAXZEVRIA vaccination plan, the last vaccination day was Sep. 30, 2022. So it was difficult to continue this study.
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To provide more information on safety profile of VAXZEVRIA in Japanese subjects, specific drug use result study in subjects with underling disease at higher risk of worsening COVID-19 is planned as an additional pharmacovigilance plan.
The present study aims to collect information on adverse drug reactions or COVID-19 infection after VAXZEVRIA vaccination and to evaluate the safety of this vaccine.
To provide more information on safety profile of VAXZEVRIA in Japanese subjects, specific drug use result study in subjects with underling disease at higher risk of worsening COVID-19 is planned as an additional pharmacovigilance plan.
The present study aims to collect information on adverse drug reactions (local/systemic reactions), adverse events (including Shock/ Anaphylaxis, Thrombosis in combination with thrombocytopenia, Immune-mediated neurological conditions ,Vaccine-associated enhanced disease(VAED) including Vaccine-associated enhanced respiratory disease(VAERD) and Thrombosis) or COVID-19 infection after VAXZEVRIA vaccination and to evaluate the safety of this vaccine
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| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse drug reactions, its incidence (%) (number of adverse drug reaction/number of eligible safety analysis population) will be calculated by preferred term (PT). | Adverse events that the investigator could not deny the causal relationship with VAXZEVRIA will be treated as adverse drug reactions. Number of adverse drug reactions, its incidence (%) (number of adverse drug reaction/number of eligible safety analysis population) will be calculated by preferred term (PT). | from the first vaccination date to 28 days after the second vaccination date |
| Number of local/systemic reactions and its incidence (%) will be calculated for each reaction and also by grade. Ad hoc analysis might be performed as necessary. | Local/systemic reactions recorded in health observation diary by subjects and entered by the investigator in eCRF will be treated as specific adverse events and number of local/systemic reactions and its incidence (%) will be calculated for each reaction and also by grade. Ad hoc analysis might be performed as necessary. | each vaccination day (Day 1) to Day 8 |
| Number of the subjects considered to be severe case of COVID-19 and its incidence (%) will be calculated. The subject who required a hospitalization in intensive care unit or use of respirator will be defined as a severe case. | Number of the subjects considered to be severe case of COVID-19 and its incidence (%) will be calculated. The subject who required a hospitalization in intensive care unit or use of respirator will be defined as a severe case based on the severity classification reference of "A guide for front-line healthcare workers (MHLW, 2020)". Ad hoc analysis might be performed as necessary. | from the first vaccination date to 28 days after the second vaccination date |
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Inclusion Criteria:
Exclusion Criteria:
None
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The subjects with underlying disease at high-risk for worsening COVID-19
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Akita | Japan | ||||
| Research Site |
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 deidentified 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.
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| Ibaraki |
| Japan |
| Research Site | Shizuoka | Japan |