Study Stopped
Business decision
Survey of the Moderna COVID-19 Vaccine in People at High-Risk of Developing Severe COVID-19 Symptoms
Special Use Results Survey: Spikevax Intramuscular Injection (Previously COVID-19 Vaccine Moderna Intramuscular Injection) for Subjects With Underlying Disease Considered to be at High Risk for Severe Illness, Acute Phase Safety Surveillance (COVID-19)
2 other identifiers
observational
N/A
1 country
1
Brief Summary
This study is a survey of the Moderna COVID-19 vaccine in Japanese people at high risk of developing severe COVID-19 symptoms. 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 side effects of the Moderna COVID-19 vaccine in this group. This will be from the first vaccination to 28 days after the second vaccination. The number of visits to the clinic will depend on the clinic's standard practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2021
CompletedFirst Posted
Study publicly available on registry
May 19, 2021
CompletedStudy Start
First participant enrolled
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2023
CompletedJuly 28, 2022
July 1, 2022
9 months
May 18, 2021
July 25, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Percentage of Participants with at least One Adverse Events (AEs)
An adverse event (Adverse Event: AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product. It does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (Including laboratory abnormalities), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
56 days
Percentage of Participants with Specified AEs (Local Reactions) at the Vaccination Site
Specified AEs (Local reactions) at the vaccination site are defined as injection site pain, redness and swelling. The participants will evaluate the symptoms at the vaccination site (local reactions) and systemic symptoms (systemic events) and will record with the health observation diary. Percentage of participants with specified AEs (local reactions) at the vaccination site will be reported.
56 days
Percentage of Participants with Specified AEs (Systemic Events)
Specified AEs (Systemic events) are defined as vomiting, diarrhoea, headache, malaise, chills, myalgia, and arthralgia. The participants will evaluate the symptoms at the vaccination site (local reactions) and systemic symptoms (systemic events) and will record with the health observation diary. Percentage of participants with specified AEs (systemic events) at the vaccination site will be reported.
56 days
Secondary Outcomes (3)
Number of Participants who Take COVID-19 Pathogen (SARS-COV-2) Test during the Study
56 days
Number of Participants who Developed COVID-19 during the Study
56 days
Number of Participants Who Have Sever COVID-19 Infection during the Study Evaluated by Investigator
56 days
Study Arms (1)
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.
Interventions
COVID-19 Vaccine Intramuscular Injection
Eligibility Criteria
The population of this survey are vaccinees who meet the inclusion/exclusion criteria.
You may qualify if:
- The participant is capable of understanding the contents of the investigation, recording his/her own symptoms in the health observation diary, and has obtained written consent to participate in the investigation from the vaccinee himself/herself (If minor, parent or legal guardian).
- The participant has an underlying disease at the time of this drug vaccination that is considered to pose a high risk of aggravation of COVID-19.
You may not qualify if:
- \. The subject has any contraindication to this drug.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (1)
Takeda Selected Site
Tokyo, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2021
First Posted
May 19, 2021
Study Start
August 1, 2022
Primary Completion
April 30, 2023
Study Completion
April 30, 2023
Last Updated
July 28, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.