Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Special Investigation of COMIRNATY in the Population With Underlying Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04880447
Recruitment Status : Recruiting
First Posted : May 10, 2021
Last Update Posted : June 11, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment
COVID-19 Biological: BNT162b2

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Special Investigation in the Population With Underlying Diseases Considered to Increase the Risk of Severe Illness of COVID-19
Actual Study Start Date : May 26, 2021
Estimated Primary Completion Date : May 6, 2022
Estimated Study Completion Date : May 6, 2022

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 Name: COMIRNATY




Primary Outcome Measures :
  1. 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. ]
  2. 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. ]
  3. 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. ]
  4. 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. ]
  5. 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. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04880447


Contacts
Layout table for location contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
Layout table for location information
Japan
Pfizer Local County Recruiting
Tokyo, Japan, 1518589
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04880447    
Other Study ID Numbers: C4591019
First Posted: May 10, 2021    Key Record Dates
Last Update Posted: June 11, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
COVID-19,
Post-Marketing study
COMIRNATY
Underlying Disease