Clinical trial NCT05135455: VAXZEVRIA Japan Post-Marketing Surveillance (PMS) for the Long-term Safety of VAXZEVRIA
Official title: VAXZEVRIA Intramuscular Injection General Use Result Study for the Long-term Safety of VAXZEVRIA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prevention of Infectious Disease Caused by SARS-CoV-2
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2021-11-26
Enrollment: 467
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The incidence of SAEs will be calculated by preferred term (PT) by overall and with/without causal relationships with VAXZEVRIA assessed by investigator(s).
timeFrame: From the next day of 28 days after the last vaccination of VAXZEVRIA up to 12 months after the last vaccination.
measure: 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.
timeFrame: From the next day of 28 days after the last vaccination of VAXZEVRIA up to 12 months after the last vaccination.
Secondary outcomes:
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: Research Site
city: Hyogo
country: Japan
facility: Research Site
city: Kumamoto
country: Japan
facility: Research Site
city: Mie
country: Japan
facility: Research Site
city: Shizuoka
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
Study officials:
References: