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Long-Term Follow-up Survey of COVID-19 Vaccine After Vaccination

Sponsor
Takeda (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04941144
Collaborator
(none)
8,538
Enrollment
1
Location
12.3
Anticipated Duration (Months)
694.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a long-term follow-up survey of Japanese people after their second vaccination with the Moderna COVID-19 vaccine.

The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

The main aim of the study is to check for long-term side effects of the COVID-19 vaccine. This will be from 28 days to 12 months after the second vaccination of the COVID-19 vaccine.

The number of visits to the clinic will depend on the clinic's standard practice.

Condition or Disease Intervention/Treatment Phase
  • Biological: COVID-19 Vaccine

Study Design

Study Type:
Observational
Actual Enrollment :
8538 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
General Use Results Survey: Spikevax Intramuscular Injection (Previously COVID-19 Vaccine Moderna Intramuscular Injection) During the Early Phase of Treatment With Novel Corona Vaccine, Follow-up of Key Survey Participants
Actual Study Start Date :
Dec 22, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
COVID-19 Vaccine Intramuscular Injection 0.5 mL

COVID-19 vaccine intramuscular injection, 2 doses of 0.5 mL per dose administered intramuscularly at an interval of 4 weeks.

Biological: COVID-19 Vaccine
COVID-19 Vaccine Intramuscular Injection
Other Names:
  • COVID-19 Vaccine Moderna Intramuscular Injection
  • Spikevax Intramuscular Injection

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants with Serious AEs (SAE) [11 months (From 28 days to 12 months after the second vaccination)]

      An SAE is defined as any untoward medical occurrence that: Results in death, Is life-threatening, Requires in patient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Leads to a congenital anomaly/birth defect in the offspring of a participant, or Is an important medical event.

    Secondary Outcome Measures

    1. Number of Participants who Take COVID-19 Pathogen (SARS-COV-2) Test during the Study [11 months (From 28 days to 12 months after the second vaccination)]

    2. Number of Participants who Developed COVID-19 during the Study [11 months (From 28 days to 12 months after the second vaccination)]

    3. Number of Participants Who Have Sever COVID-19 Infection during the Study Evaluated by Investigator [11 months (From 28 days to 12 months after the second vaccination)]

      Number of participants who have sever COVID-19 infection during the study evaluated by investigator will be reported. Investigator will evaluate the severity of COVID-19 infection with COVID-19 information entered in the case report form in reference to "Guidance for Clinical Practice of Novel Coronavirus Infection (COVID-19)".

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    The participant who has participated in the preceding cohort study and has subsequently obtained written consent from the vaccinee himself/herself to participate in this study.

    Exclusion Criteria:

    None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Takeda selected site Tokyo Japan

    Sponsors and Collaborators

    • Takeda

    Investigators

    • Study Director: Study Director, Takeda

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Takeda
    ClinicalTrials.gov Identifier:
    NCT04941144
    Other Study ID Numbers:
    • PNR-1474
    • jRCT2031210168
    First Posted:
    Jun 28, 2021
    Last Update Posted:
    Jul 14, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    COVID-19
    Vaccines

    Study Results

    No Results Posted as of Jul 14, 2022