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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04880447
Recruitment Status : Active, not recruiting
First Posted : May 10, 2021
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date May 5, 2021
First Posted Date May 10, 2021
Last Update Posted Date September 28, 2021
Actual Study Start Date May 26, 2021
Estimated Primary Completion Date May 6, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 10, 2021)
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
Original Primary Outcome Measures
 (submitted: May 5, 2021)
  • 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. ]
  • 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. ]
  • Proportion of subjects with Adeverse reactions [ Time Frame: 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. ]
  • 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. ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Special Investigation of COMIRNATY in the Population With Underlying Diseases
Official Title Special Investigation in the Population With Underlying Diseases Considered to Increase the Risk of Severe Illness of COVID-19
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.)
Condition COVID-19
Intervention 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
Study Groups/Cohorts COMIRNATY
COVID-19 mRNA vaccine
Intervention: Biological: BNT162b2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: September 27, 2021)
1075
Original Estimated Enrollment
 (submitted: May 5, 2021)
1000
Estimated Study Completion Date May 6, 2022
Estimated Primary Completion Date May 6, 2022   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT04880447
Other Study ID Numbers C4591019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2021