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Observational study on the evaluation of COVID-19 prevention and subjects' health status after SARS-CoV-2 vaccination

Observational study on the evaluation of COVID-19 prevention and subjects' health status after SARS-CoV-2 vaccination - Observational study on the evaluation of COVID-19 prevention and subjects' health status after SARS-CoV-2 vaccination

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000045107
Enrollment
8200
Registered
2021-08-10
Start date
2021-08-16
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Interventions

None listed

Sponsors

Shionogi & Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Employee and their family members in Shionogi & Co. Ltd. (including its group companies) and other companies who can perform evaluation by application by themselves. 2) Employee and their family members in Shionogi & Co. Ltd. (including its group companies) and other companies who consented to this study by their own will with substantial understanding of this research by reading through ICF. 3) Employee and their family members in Shionogi & Co. Ltd. (including its group companies) and other companies with either of the following condition: (A) Those who are vaccinated for SARS-CoV-2. The 1st vaccination was performed less than 6 months before of obtaining their consent. (B) Those who have not been vaccinated for SARS-CoV-2. They are not applied for or will not be vaccinated by November 2021. 4) Those who can download the application for this study and enter the data through the application.

Exclusion criteria

Exclusion criteria: Those who do not consent to this study

Design outcomes

Primary

MeasureTime frame
SARS-CoV-2 positive rate at 6-months

Secondary

MeasureTime frame
The following endpoints at 3, 6, 9, and 12 months: - SARS-CoV-2 positive rate (except for 6 month as this is defined as the primary endpoint) - COVID-19 incidence rate - Incidence rate of COVID-19-related symptoms - Rate of subjects in each COVID-19 infection severity - Household transmission rate - Incidence rate of symptoms which were observed after SARS-CoV-2 vaccination

Countries

Japan

Contacts

Public ContactShintaro Tanaka

Shionogi & Co., Ltd. Medical Affairs Department

shintarou.tanaka@shionogi.co.jp03-5219-7306

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026