Long-Term Follow-up Survey of COVID-19 Vaccine after vaccination

JRCT ID: jRCT2031210168

Registered date:29/06/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Prevention of infectious disease caused by SARS-CoV-2
• Date of first enrollment: 22/12/2021
• Target sample size: 8538
• Study type: Observational

Outcome(s)

Primary Outcome

1.Percentage of Participants with Serious AEs (SAE)
Time Frame: 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 inpatient 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

1.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)

2.Number of Participants who Developed COVID-19 during the Study
Time Frame: 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
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 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)".

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include criteria: 1. 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.
• Exclude criteria: none

Related Information

• Primary Sponsor: Contact for Clinical Trial Information
• Secondary ID(s): NCT04941144