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

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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Key information

Conditions

Prevention of Infectious Disease Caused by SARS-CoV-2

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Chiba, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

The incidence of SAEs will be calculated by preferred term (PT) by overall and with/without causal relationships with VAXZEVRIA assessed by investigator(s).

Time frame: From the next day of 28 days after the last vaccination of VAXZEVRIA up to 12 months after the last vaccination.

The incidence of SAEs (including thrombosis in combination with thrombocytopenia, immune-mediated neurological conditions and VAED including VAERD, thrombosis or other diseases) will be calculated by preferred term (PT) by overall and with/without causal relationships with VAXZEVRIA assessed by investigator(s).
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.

Time frame: From the next day of 28 days after the last vaccination of VAXZEVRIA up to 12 months after the last vaccination.

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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

VAXZEVRIA Intramuscular Injection General Use Result Study for the Long-term Safety of VAXZEVRIA

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Nov 26, 2021
Registry last updated: Sep 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.