NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2031210470

Registered date:06/12/2021

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

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedPrevention of COVID-19
Date of first enrollment03/12/2021
Target sample size204
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)S-268019 or COMIRNATY (intramuscular injection)

Outcome(s)

Primary OutcomeSARS-CoV-2 neutralizing antibody titer on Day 29
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteriaParticipant 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.
Exclude criteriaPositive 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.

Related Information

Contact

Public contact
Name Corporate Communications Department -
Address 1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka Osaka Japan 541-0045
Telephone +81-6-6209-7885
E-mail shionogiclintrials-admin@shionogi.co.jp
Affiliation Shionogi & Co., Ltd.
Scientific contact
Name Tsutae Nagata
Address 1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka Osaka Japan 541-0045
Telephone +81-6-6209-7885
E-mail shionogiclintrials-admin@shionogi.co.jp
Affiliation Shionogi & Co., Ltd.