Clinical trial NCT05212948: A Study of S-268019 for the Prevention of COVID-19
Official title: A Phase 3, Randomized, Observer-Blind, Placebo- Controlled Cross-over Study to Evaluate the Efficacy, Safety, and Immunogenicity of S-268019 for the Prevention of COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: SARS-CoV-2
Lead sponsor: Shionogi Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-28
Enrollment: 9902
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The main purpose of this study is to assess the efficacy of S-268019-b for the prevention of COVID-19 in the initial vaccination period prior to crossover in participants without evidence of infection before vaccination as compared to placebo.

Detailed description: Eligible participants will be randomized to receive either S-268019-b or placebo first and then will be crossed over to receive the opposite intervention. The study will consist of two treatment periods, an initial vaccination period (Day 1 to Day 224), and a crossover vaccination period (Day 225 to Day 435).

Eligibility criteria: Inclusion Criteria:

* Agree not to participate in any other SARS-CoV-2 prevention trial during the study follow-up.
* Capable of using Diary without difficulties (if applicable, with assistance by caregiver).

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).
* Previous vaccination against SARS-CoV-2.
* Any inactivated vaccine received within 14 days prior to the first dose of study intervention.
* Any live vaccine received within 28 days prior to the first dose of study intervention.
* Immunoglobulin preparations, blood products, or a blood transfusion within 3 months prior to the first dose of study intervention.

Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Number of Participants With First Occurrence of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Reverse Transcription Polymerase Chain Reaction (RT-PCR)-Positive Symptomatic COVID-19 in the Initial Vaccination Period
timeFrame: 14 days after the second dose administration
Secondary outcomes:
measure: Number of Participants With First Occurrence of SARS-CoV-2 RT-PCR-Positive Severe COVID-19 in the Initial Vaccination Period with Onset at Least 14 Days Following Second Vaccination
timeFrame: 14 days after the second dose administration
measure: Number of Participants With First Occurrence of SARS-CoV-2 RT-PCR-Positive Symptomatic COVID-19 in the Initial Vaccination Period
timeFrame: Up to Day 224
measure: Number of Participants With First Occurrence of SARS-CoV-2 RT-PCR-Positive Severe COVID-19 in the Initial Vaccination Period
timeFrame: Up to Day 224
Other outcomes:
Locations:
city: Buon Ma Thuot City
country: Vietnam
facility: Buon Ma Thuot City Medical Center
state: Dak Lak
Study officials:
References: