A Booster Study of S-268019 in Japan-2 (COVID-19)

A Phase 3, Open-label Study to Evaluate Safety of a Booster Dose of S-268019 in Adults and Older Adults Who Have Completed COVID-19 Vaccine as a Primary Series (COVID-19)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031210613

Enrollment

150

Registered

2022-02-17

Start date

2022-02-28

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

One dose of S-268019 via intramuscular injection. Participants who provided informed consent for the second booster dose will receive one dose of S-268019 again via 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 SARS-CoV-2 vaccine (Adults:only SPIKEVAX, Older adults: COMIRNATY or SPIKEVAX) and 6 months or more and 8 months or less after 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
Safety	—

Contacts

Public Contact- -

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