UMIN-CTR Clinical Trial

Public title

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

Acronym

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

Scientific Title

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

Scientific Title:Acronym

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

Region

Japan

Condition

COVID-19

Classification by specialty

Infectious disease

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We conduct a questionnaire survey for participants, who are employee and their family members, with or without vaccination in order to evaluate SARS-CoV-2 vaccine's long-term preventive effect in Japan.
In addition, we conduct a questionnaire survey after SARS-CoV-2 vaccination in order to evaluate participants' health status after SARS-CoV-2 vaccination.
Further, we evaluate the relation between serum neutralizing antibody titer and SARS-CoV-2 infection by analyzing with the result from "Prospective study on evaluation of immunological response after SARS-CoV-2 vaccination" which we conduct parallelly.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

SARS-CoV-2 positive rate at 6-months

Key secondary outcomes

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key 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.

Key exclusion criteria

Those who do not consent to this study

Target sample size

8200

Name of lead principal investigator

1st name	Hiroyuki
Middle name
Last name	Kunishima

Organization

St. Marianna University

Division name

Department of Infectious Diseases

Zip code

216-8511

Address

2-16-1 Sugao Miyamaeku Kawasaki city, Kanagawa, Japan

TEL

044-977-8111

Email

h2kuni@marianna-u.ac.jp

Name of contact person

1st name	Shintaro
Middle name
Last name	Tanaka

Organization

Shionogi & Co., Ltd.

Division name

Medical Affairs Department

Zip code

100-0005

Address

1-8-2, Marunouchi, Chiyoda-ku, Tokyo, Japan

TEL

03-5219-7306

Homepage URL

Email

shintarou.tanaka@shionogi.co.jp

Institute

Shionogi & Co., Ltd.

Institute

Department

Personal name

Organization

Shionogi & Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Non-Profit Organization MINS Research Ethics Committee

Address

5-20-9-401, Mita, Minato-ku, Tokyo, Japan

Tel

03-6416-1868

Email

npo-mins@j-irb.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2021

Year

08

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

829

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2021

Year

08

Month

03

Day

Date of IRB

2021

Year

08

Month

04

Day

Anticipated trial start date

2021

Year

08

Month

16

Day

Last follow-up date

2022

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

None

Registered date

2021

Year

08

Month

10

Day

Last modified on

2023

Year

08

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051520