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 at a glance
What medical condition is being studied? Prevention of Infectious Disease Caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2)
What is the trial testing? COVID-19 Vaccine
Are placebos part of the trial? No
How many participants are being enrolled? 20000
When is the trial being conducted? -
Accepts Healthy Volunteers?
Trial Details / Participation Requirements
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Trial Type: Observational
Trial Arms/Groups or Cohorts:
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.
Intervention: COVID-19 Vaccine
Primary Outcome Measure(s):
Percentage of Participants with Serious AEs (SAE) [Time Frame: 11 months (From 28 days to 12 months after the second vaccination)]
Secondary Outcome Measure(s):
Number of Participants who Take COVID-19 Pathogen (SARS-COV-2) Test during the Study [Time Frame: 11 months (From 28 days to 12 months after the second vaccination)]
Number of Participants who Developed COVID-19 during the Study [Time Frame: 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 [Time Frame: 11 months (From 28 days to 12 months after the second vaccination)]
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.
Takeda selected site
2,960 miles (4,763 km) awayfrom Новосибирск, Новосибирская область
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Trial Protocol ID: PNR-1474
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