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

Completed

• Conditions: Prevention of Infectious Disease Caused by SARS-CoV-2

• Registration Number: NCT05135455
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-11-16
• Study First Submitted QC: 2021-11-16
• Study First Posted: 2021-11-26
• Study Start: 2022-04-21
• Primary Completion: 2023-10-10
• Study Completion: 2023-10-10
• Status Verified: 2023-11
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 467

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Research Site; 🇯🇵 Tokyo, Japan