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Dec. 06, 2021

Aug. 07, 2022

jRCT2031210470

A Phase 2/3, Randomized, Observer-Blind, Active-Controlled Study to Evaluate the Immunogenicity of a Booster Dose of S-268019 or COMIRNATY (COVID-19)

A Booster Study of S-268019 in Japan (COVID-19)

Nagata Tsutae

Shionogi & Co., Ltd.

1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka

+81-6-6209-7885

shionogiclintrials-admin@shionogi.co.jp

- Corporate Communications Department

Shionogi & Co., Ltd.

1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka

+81-6-6209-7885

shionogiclintrials-admin@shionogi.co.jp

Not Recruiting

Dec. 06, 2021

Dec. 03, 2021
204

Interventional

randomized controlled trial

double blind

active control

parallel assignment

prevention purpose

Participant must be >= 20 years of age inclusive, at the time of signing the informed consent.
Participant who have received 2 doses of COMIRNATY and at least 6 months post second dose.

Positive SARS-CoV-2 antigen test result at Screening.
A known history of SARS-CoV-2 infection as determined by medical interview before study intervention.
Participant has a contraindication to IM injections or blood draws.

20age 0month 0week old over
No limit

Both

Prevention of COVID-19

S-268019 or COMIRNATY (intramuscular injection)

SARS-CoV-2 neutralizing antibody titer on Day 29

Shionogi & Co., Ltd.
Ministry of Health, Labour and Welfare
Not applicable
Institutional Review Board of Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai
3-22, Higashioi 6-chome, Shinagawa-ku, Tokyo

+81-3-3764-0511

ueda.satsuki@neues.co.jp
Approval

No

none

History of Changes

No Publication date
3 Aug. 07, 2022 (this page) Changes
2 Jan. 19, 2022 Detail Changes
1 Dec. 06, 2021 Detail