S-268019-b vs Placebo: 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 Regardless of Serostatus or PCR Status at Baseline
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0 | 0 | 0.000635 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.00033 | 0.0000582 | 0.00186 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.00033 | -0.00186 | 0.000361 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | ClinicalTrials.gov | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | ClinicalTrials.gov | |||
| Number needed to treat, for one fewer participant with the outcome on S-268019-b than on Placebo | 3,030 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | S-268019-b | Participants received a dose of S-268019-b via intramuscular injection on Day 1 and Day 29 during the Initial Vaccination Period. | 0 | 6,049 | OG000 | ClinicalTrials.gov |
| Group 2 | Placebo | Participants received a dose of placebo via intramuscular injection (matching S-268019-b) on Day 1 and Day 29 during the Initial Vaccination Period. | 1 | 3,034 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | 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 Regardless of Serostatus or PCR Status at Baseline | ClinicalTrials.gov |
| Description | For participants confirmed to have symptomatic COVID-19 within at least 14 days following the second vaccination, the investigator evaluated if the maximum intensity during the course of the disease met the protocol-specified criteria for severe COVID-19. | ClinicalTrials.gov |
| Time frame | From Day 43 (14 days after the second dose administration) to Day 224 | ClinicalTrials.gov |
| Population | Full Analysis Set (FAS): all randomized participants who received at least 1 dose of the study intervention during the Initial Vaccination Period. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. Only data collected during the Initial Vaccination Period reported for this outcome measure. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | A Study of S-268019 for the Prevention of COVID-19 | ClinicalTrials.gov |
| NCT number | NCT05212948 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | SARS-CoV-2 | ClinicalTrials.gov |
| Interventions | S-268019-b, Placebo | ClinicalTrials.gov |
| Lead sponsor | Shionogi | ClinicalTrials.gov |
| Results first posted | 2025-11-28 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT05212948?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| Tables read | outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.