Clinical trial NCT04880447: Special Investigation of COMIRNATY in the Population With Underlying Diseases
Official title: Special Investigation of COMIRNATY Intramuscular Injection (Investigation of Patients With Underlying Disease Considered to be at High Risk of Aggravation of COVID-19)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19,
Post-Marketing study
COMIRNATY
Underlying Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-05-10
Enrollment: 1075
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with underlying disease considered to be at high risk of aggravation of COVID-19 (Underlying diseases considered to be at high risk of aggravation of COVID-19 are based on the range of patients with underlying diseases indicated by the Ministry of Health, Labour and Welfare for priority vaccination.)

Brief summary: Post-marketing study, Cohort study of COMIRNATY vaccines. To collect information on adverse events and COVID-19 observed after vaccination with COMIRNATY and to assess safety in patients with underlying disease considered to be at high risk of aggravation of COVID-19 who have received vaccination with this product under actual use conditions.

Detailed description: This is a multicenter cohort study to be conducted in individuals with underlying diseases considered to be at high risk of aggravation of COVID-19 who are vaccinated with this product, and the investigator will enter the information required in this study in the case report forms (CRFs) based on the information obtained through preliminary examination sheet or medical interview, etc. and records such as medical records. A health observation diary will be distributed to the subjects participating in this study and they will be requested to record information on local reactions and systemic reactions after vaccination with this product.

Eligibility criteria: Inclusion Criteria:

-Subjects who are able to understand the content of this study and to record their symptoms in the health observation diary, and who have provided written consent to participate in this survey by themselves (or parents or legal guardians in the case of minors)

Exclusion Criteria:

* There are no exclusion criteria for this study.

Primary outcomes:
measure: Proportion of Participants With Adverse Reactions
timeFrame: From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
measure: Proportion of Participants With Serious Adverse Reactions
timeFrame: From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
measure: Proportion of Participants With Local Reactions and Systemic Reactions (The First Vaccination)
timeFrame: Within 8 days after the date of the first dose.
measure: Proportion of Participants With Local Reactions and Systemic Reactions (The Second Vaccination)
timeFrame: Within 8 days after the date of the second dose.
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Pfizer Local County
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: