Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Drug Use Investigation of COMIRNATY Intramuscular Injection

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: NCT04815031
Recruitment Status : Recruiting
First Posted : March 24, 2021
Last Update Posted : November 8, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date March 22, 2021
First Posted Date March 24, 2021
Last Update Posted Date November 8, 2021
Actual Study Start Date April 20, 2021
Estimated Primary Completion Date October 22, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 22, 2021)
  • The number of subjects with serious Adverse Events [ Time Frame: 11 months from the day following 28 days after the final vaccination of COMIRNATY ]
    The long-term safety of this product will be assessed.
  • Proportion of subjects withe serious Adverse Events [ Time Frame: 11months from the day following 28days after the final vaccination of COMIRNATY ]
    The long-term safety of this product will be assessed.
  • Number of subjects with severe COVID-19 [ Time Frame: 11 months from the day following 28 days after the final vaccination of COMIRNATY ]
    The long-term safety of this procuct will be assessed.
  • Proportion of subjects with severe COVID-19 [ Time Frame: 11 months from the day following 28 days after final vaccination of COMIRNATY ]
    The long-term safety of this produt will be assessed.
Original Primary Outcome Measures Same as current
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 Drug Use Investigation of COMIRNATY Intramuscular Injection
Official Title General Investigation of COMIRNATY Intramuscular Injection (Follow-up Study for Subjects [Healthcare Professionals] Who Are Vaccinated at an Early Post-Approval Stage)
Brief Summary Post-marketing study, Chotor study of COMIRNATY vaccenees followed for 11months. Serious adverse events and COVID-19 observed during the follow-up period will be collected, and the long-term safety of this product will be assessed.
Detailed Description Healthcare professionals who are vaccinated with this product early after the marketing approval of COMIRNATY(participants in the Investigation of Health Status of Recipients Vaccinated First conducted by the Science Research Group of the Ministry of Health, Labour and Welfare) will be followed for 11 months from the day following 28 days after the final vaccination of this product (end date of observation period in Investigation of Health Status of Recipients Vaccinated First) to 12 months after the final vaccination of this product, information on serious adverse events and COVID-19 observed during the follow-up period will be collected, and the long-term safety of this product will be assessed (to be conducted as 11-month follow-up investigation after completion of Investigation of Health Status of Recipients Vaccinated First).
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 All subjects who have been vaccinated with this product and have consented to participate in this study during participation in the Investigation of Health Status of Recipients Vaccinated First at contract sites.
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. Individuals 16 years of age and older.
Other Name: COMIRNATY
Study Groups/Cohorts COMIRNATY
COVID-19 mRNA vaccine (nucleoside-modified)
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 Recruiting
Estimated Enrollment
 (submitted: March 22, 2021)
20000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 3, 2022
Estimated Primary Completion Date October 22, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Subjects who have participated in the Investigation of Health Status of Recipients Vaccinated First and have provided written consent to continue participation in this study.

Exclusion Criteria:

  • No exclusion criteria.
Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT04815031
Other Study ID Numbers C4591006
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 October 2021