VAXZEVRIA Japan Post-Marketing Surveillance (PMS) for the Long-term Safety of VAXZEVRIA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

467 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-21

Study Completion Date

2023-08-31

Brief Summary

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This survey will be conducted for the subjects who participate in the priority survey (cohort survey) conducted by the Scientific Research Group of the Ministry of Health, Labour and Welfare at the initial stage of administration of the COVID-19 vaccination. The present study aims to collect information on serious adverse events or COVID-19 infection observed from 28 days after the last vaccination of VAXZEVRIA up to 12 months after the last vaccination and to evaluate the long-term safety of this vaccine.

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Detailed Description

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This survey will be conducted for the subjects who participate in the priority survey (cohort survey) conducted by the Scientific Research Group of the Ministry of Health, Labour and Welfare at the initial stage of administration of the COVID-19 vaccination.

The present study aims to collect information on serious adverse events (including Thrombosis in combination with thrombocytopenia, Immune-mediated neurological conditions, Vaccine-associated enhanced disease (VAED) including Vaccine-associated enhanced respiratory disease(VAERD), Thrombosis or other diseases) or COVID-19 infection observed from 28 days after the last vaccination of VAXZEVRIA up to 12 months after the last vaccination and to evaluate the long-term safety of this vaccine.

Conditions

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Prevention of Infectious Disease Caused by SARS-CoV-2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

The subjects who participated in the cohort study conducted by the Scientific Research Group of the MHLW and those who give written consents for this study.