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Special Investigation of COMIRNATY in the Population With Underlying Diseases

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT04880447
Collaborator
(none)
1,075
Enrollment
1
Location
10.6
Actual Duration (Months)
101.3
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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.

Study Design

Study Type:
Observational
Actual Enrollment :
1075 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Special Investigation of COMIRNATY Intramuscular Injection (Investigation of Patients With Underlying Disease Considered to be at High Risk of Aggravation of COVID-19)
Actual Study Start Date :
May 26, 2021
Actual Primary Completion Date :
Apr 14, 2022
Actual Study Completion Date :
Apr 14, 2022

Arms and Interventions

Arm 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 Names:
  • COMIRNATY

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of subjects with Adverse reactions [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 [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 [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 [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 [From the date of the first vaccination with COMIRNATY (Day 1) to 28 days after the second vaccination.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Local County Tokyo Japan 1518589

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT04880447
    Other Study ID Numbers:
    • C4591019
    First Posted:
    May 10, 2021
    Last Update Posted:
    May 10, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of May 10, 2022