Special Investigation of COMIRNATY in the Population With Underlying Diseases

May 5, 2022 updated by: Pfizer

Special Investigation of COMIRNATY Intramuscular Injection (Investigation of Patients With Underlying Disease Considered to be at High Risk of Aggravation of COVID-19)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1075

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan, 1518589
        • Pfizer Local County

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COMIRNATY
COVID-19 mRNA vaccine
Biological: BNT162b2
COMIRNATY is administered intramuscularly after dilution as a course of 2 doses (0.3 mL each). It is recommended to administer the second dose 3 weeks after the first dose.
Other Names:
  • COMIRNATY

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of subjects with Adverse reactions
Time Frame: From the date of the first vaccination with COMIRNATY (Day 1) to 28 days after the second vaccination.
From the date of the first vaccination with COMIRNATY (Day 1) to 28 days after the second vaccination.
Number of subjects with Serious adverse reactions
Time Frame: From the date of the first vaccination with COMIRNATY (Day 1) to 28 days after the second vaccination.
From the date of the first vaccination with COMIRNATY (Day 1) to 28 days after the second vaccination.
Proportion of subjects with Adverse reactions
Time Frame: From the date of the first vaccination with COMIRNATY (Day 1) to 28 days after the second vaccination.
From the date of the first vaccination with COMIRNATY (Day 1) to 28 days after the second vaccination.
Proportion of subjects with Serious adverse reactions
Time Frame: From the date of the first vaccination with COMIRNATY (Day 1) to 28 days after the second vaccination.
From the date of the first vaccination with COMIRNATY (Day 1) to 28 days after the second vaccination.
Proportion of subjects with local reaction and systemic events
Time Frame: From the date of the first vaccination with COMIRNATY (Day 1) to 28 days after the second vaccination.
From the date of the first vaccination with COMIRNATY (Day 1) to 28 days after the second vaccination.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2021

Primary Completion (Actual)

April 14, 2022

Study Completion (Actual)

April 14, 2022

Study Registration Dates

First Submitted

May 5, 2021

First Submitted That Met QC Criteria

May 5, 2021

First Posted (Actual)

May 10, 2021

Study Record Updates

Last Update Posted (Actual)

May 10, 2022

Last Update Submitted That Met QC Criteria

May 5, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C4591019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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