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

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)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031210470

Enrollment

204

Registered

2021-12-06

Start date

2021-12-03

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

Prevention of COVID-19

Interventions

S-268019 or COMIRNATY (intramuscular injection)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
SARS-CoV-2 neutralizing antibody titer on Day 29	—

Contacts

Public ContactCorporate Communications Department -

Shionogi & Co., Ltd.

shionogiclintrials-admin@shionogi.co.jp+81-6-6209-7885

Outcome results

None listed

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