Study identifier:D8111C00005
ClinicalTrials.gov identifier:NCT05135455
EudraCT identifier:N/A
CTIS identifier:N/A
VAXZEVRIA Intramuscular injection General use result study for the long-term safety of VAXZEVRIA
Prevention of infectious disease caused by SARS-CoV-2
N/A
No
-
All
467
Observational
n/a - n/a
Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 Aug 2024 by AstraZeneca
AstraZeneca
-
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.
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.
Location
Location
Chiba, Japan
Location
Tokyo, Japan
Location
Shizuoka, Japan
Location
Mie, Japan
Location
Hyogo, Japan
Location
Kumamoto, Japan
Arms | Assigned Interventions |
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