Clinical trial NCT05084755: VAXZEVRIA Japan Post-Marketing Surveillance (PMS) for the Subjects With Underlying Disease at High-risk for Worsening COVID-19
Official title: VAXZEVRIA Intramuscular Injection Specific Use Result Study for the Subjects With Underlying Disease at High-risk for Worsening COVID-19
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prevention of Infectious Disease Caused by SARS-CoV-2
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2021-10-20
Enrollment: 4
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 with underlying disease at high-risk for worsening COVID-19

Brief summary: To provide more information on safety profile of VAXZEVRIA in Japanese subjects, specific drug use result study in subjects with underling disease at higher risk of worsening COVID-19 is planned as an additional pharmacovigilance plan.

The present study aims to collect information on adverse drug reactions or COVID-19 infection after VAXZEVRIA vaccination and to evaluate the safety of this vaccine.

Detailed description: To provide more information on safety profile of VAXZEVRIA in Japanese subjects, specific drug use result study in subjects with underling disease at higher risk of worsening COVID-19 is planned as an additional pharmacovigilance plan.

The present study aims to collect information on adverse drug reactions (local/systemic reactions), adverse events (including Shock/ Anaphylaxis, Thrombosis in combination with thrombocytopenia, Immune-mediated neurological conditions ,Vaccine-associated enhanced disease(VAED) including Vaccine-associated enhanced respiratory disease(VAERD) and Thrombosis) or COVID-19 infection after VAXZEVRIA vaccination and to evaluate the safety of this vaccine

Eligibility criteria: Inclusion Criteria:

1. The subjects with underlying disease at high-risk for worsening COVID-19.
2. The adults (in the case of a minor aged less than 20 years, the parent or the legal guardian) who are able to enter their symptoms in the health observation diary and who have been fully informed and have given written consent to the use of the needed information to be part of the observational study.

Exclusion Criteria:

None

Primary outcomes:
measure: Number of adverse drug reactions, its incidence (%) (number of adverse drug reaction/number of eligible safety analysis population) will be calculated by preferred term (PT).
timeFrame: from the first vaccination date to 28 days after the second vaccination date
measure: Number of local/systemic reactions and its incidence (%) will be calculated for each reaction and also by grade. Ad hoc analysis might be performed as necessary.
timeFrame: each vaccination day (Day 1) to Day 8
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 first vaccination date to 28 days after the second vaccination date
Secondary outcomes:
Other outcomes:
Locations:
city: Akita
country: Japan
facility: Research Site
city: Ibaraki
country: Japan
facility: Research Site
city: Shizuoka
country: Japan
facility: Research Site
Study officials:
References: