Long-Term Follow-up Survey of COVID-19 Vaccine After Vaccination
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
2 other identifiers
observational
8,538
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2021
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
June 25, 2021
CompletedFirst Posted
Study publicly available on registry
June 28, 2021
CompletedStudy Start
First participant enrolled
December 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2023
CompletedMay 19, 2023
May 1, 2023
1.3 years
June 25, 2021
May 17, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants with Serious Adverse Events (SAE)
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.
11 months (From 28 days to 12 months after the second vaccination)
Secondary Outcomes (3)
Number of Participants who Take COVID-19 Pathogen (Severe Acute Respiratory Syndrome coronavirus [SARS-CoV-2]) Test during the Study
11 months (From 28 days to 12 months after the second vaccination)
Number of Participants who Developed COVID-19 during the Study
11 months (From 28 days to 12 months after the second vaccination)
Number of Participants Who Have Severe COVID-19 Infection during the Study Evaluated by Investigator
11 months (From 28 days to 12 months after the second vaccination)
Study Arms (1)
COVID-19 Vaccine Intramuscular Injection 0.5 milliliters (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 vaccinated participants who meet the inclusion/exclusion criteria.
You may qualify if:
- Participants who have participated in the preceding cohort study and has subsequently provided written consent to participate in this study.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ModernaTX, Inc.lead
Study Sites (1)
Moderna selected site
Tokyo, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2021
First Posted
June 28, 2021
Study Start
December 22, 2021
Primary Completion
April 28, 2023
Study Completion
April 28, 2023
Last Updated
May 19, 2023
Record last verified: 2023-05