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

AstraZeneca logo

AstraZeneca

Status

Completed

Conditions

Prevention of Infectious Disease Caused by SARS-CoV-2

Study type

Observational

Funder types

Industry

Identifiers

NCT05135455
D8111C00005

Details and patient eligibility

About

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.

Full description

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.

Enrollment

467 patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Exclusion criteria

None

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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