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Drug Use Investigation of COMIRNATY Intramuscular Injection

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ClinicalTrials.gov Identifier: NCT04815031
Recruitment Status : Recruiting
First Posted : March 24, 2021
Last Update Posted : October 19, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

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

Detailed Description:
The 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).

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Study Type : Observational
Estimated Enrollment : 20000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: General Investigation of COMIRNATY Intramuscular Injection (Follow-up Study for Subjects [Healthcare Professionals] Who Are Vaccinated at an Early Post-Approval Stage)
Actual Study Start Date : April 20, 2021
Estimated Primary Completion Date : October 22, 2022
Estimated Study Completion Date : December 3, 2022

Group/Cohort Intervention/treatment
COMIRNATY
COVID-19 mRNA vaccine (nucleoside-modified)
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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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
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.
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.

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): NCT04815031


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Japan
PfizerLocal Country Office Recruiting
Tokyo, Japan, 1518589
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04815031    
Other Study ID Numbers: C4591006
First Posted: March 24, 2021    Key Record Dates
Last Update Posted: October 19, 2021
Last Verified: October 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.

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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,Vaccine
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases