Drug Use Investigation of COMIRNATY Intramuscular Injection
General Investigation of COMIRNATY Intramuscular Injection (Follow-up Study for Subjects [Healthcare Professionals] Who Are Vaccinated at an Early Post-Approval Stage)
1 other identifier
observational
14,570
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 20, 2021
CompletedFirst Submitted
Initial submission to the registry
March 22, 2021
CompletedFirst Posted
Study publicly available on registry
March 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 27, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 27, 2023
CompletedResults Posted
Study results publicly available
October 30, 2024
CompletedNovember 27, 2024
October 1, 2024
1.9 years
March 22, 2021
December 14, 2023
November 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Proportion of Participants With Serious Adverse Events
A serious adverse event was any untoward medical occurrence resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; or congenital anomaly.
From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination was 11 months, If booster vaccination was conducted, up to the day before booster vaccination.
Proportion of Participants With Severe COVID-19
By using the information on COVID-19 entered in the CRF submitted by the physician, participants who were considered to be in a severe condition were identified and the number and proportion of the participants were tabulated with reference to the severity classification in the Guidance for Treatment of Novel Coronavirus Infection (COVID-19). Participants with severe COVID-19 were defined as any of the following actions taken during the period from disease onset to the outcome date: admission to an ICU; use of mechanical ventilation; or use of ECMO.
From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination was 11 months, If booster vaccination was conducted, up to the day before booster vaccination.
Proportion of Participants With Serious Adverse Reactions
A serious adverse reaction was any untoward medical occurrence attributed to COMIRNATY resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; or congenital anomaly. Relatedness to COMIRNATY was assessed by the physician.
From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination was 11 months, If booster vaccination was conducted, up to the day before booster vaccination.
Number of Participants With Serious Adverse Events After Booster Vaccination
A serious adverse event was any untoward medical occurrence resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; or congenital anomaly.
From the day of booster vaccination up to 11 months from the day following 28 days after the final vaccination of COMIRNATY. (out of scope of the safety evaluation)
Number of Participants With Severe COVID-19 After Booster Vaccination
By using the information on COVID-19 entered in the CRF submitted by the physician, participants who were considered to be in a severe condition were identified and the number and proportion of the participants were tabulated with reference to the severity classification in the Guidance for Treatment of Novel Coronavirus Infection (COVID-19). Participants with severe COVID-19 were defined as any of the following actions taken during the period from disease onset to the outcome date: admission to an ICU; use of mechanical ventilation; or use of ECMO.
From the day of booster vaccination up to 11 months from the day following 28 days after the final vaccination of COMIRNATY. (out of scope of the safety evaluation)
Number of Participants With Serious Adverse Reactions After Booster Vaccination
A serious adverse reaction was any untoward medical occurrence attributed to the vaccines received as a booster vaccination resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; or congenital anomaly. Relatedness to COMIRNATY was assessed by the physician.
From the day of booster vaccination up to 11 months from the day following 28 days after the final vaccination of COMIRNATY. (out of scope of the safety evaluation)
Study Arms (1)
COMIRNATY
COVID-19 mRNA vaccine (nucleoside-modified)
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
PfizerLocal Country Office
Tokyo, 1518589, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2021
First Posted
March 24, 2021
Study Start
March 20, 2021
Primary Completion
January 27, 2023
Study Completion
January 27, 2023
Last Updated
November 27, 2024
Results First Posted
October 30, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share
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.