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A Phase 3 Study to Compare the Immunogenicity against COVID-19, of S-268019 to the ChAdOx1 nCoV-19 vaccine (COVID-19)

A Phase 3, Randomized, Observer-Blind, Active-Controlled Study to Compare the Immunogenicity against COVID-19, of S-268019 to the ChAdOx1 nCoV-19 vaccine (COVID-19)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2051210151
Enrollment
1000
Registered
2022-01-13
Start date
2022-01-17
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-b or ChAdOx1 nCoV-19 vaccine (intramuscular injection) Only the participants who agree to receive the third vaccination will be given a booster vaccination of S-268019-b.

Sponsors

Nagata Tsutae
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Participant must be >= 18 years of age, at the time of signing the informed consent form (ICF). Male and female Capable of giving signed ICF which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

Exclusion criteria

Exclusion criteria: Current or history of a laboratory-confirmed diagnosis of SARS-CoV-2 infection or COVID-19. Unstable current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disease that, in the opinion of the investigator or subinvestigator, would constitute a safety concern or confound data interpretation. Immunosuppression (immunodeficiency, acquired immunodeficiency syndrome [AIDS], use of systemic steroids, use of immunosuppressants within the past 6 months prior to the first dose of study intervention, treatment for malignant tumors, other immunosuppressive therapy). Individuals considered to have hypersensitivity to any of the study interventions,or components thereof, or drug or other allergy that, in the opinion of the investigator or subinvestigator, contraindicates participation in the study (except for pollinosis and atopic dermatitis). Participant has a contraindication to intramuscular(IM) injections or blood draws.

Design outcomes

Primary

MeasureTime frame
Primary Vaccination Part SARS-CoV-2 neutralizing antibody titer at 28 days following the second vaccination Booster Vaccination Part SARS-CoV-2 neutralizing antibody titer at 28 days following the booster vaccination

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