Double-blind Phase: Ad26.COV2.S 5*10^10 vp vs Double-blind Phase: Placebo: Number of Participants With First Occurrence of COVID-19 Requiring Medical Intervention (Double Blind Phase)
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 | 0.000837 | 0.000515 | 0.00136 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.00338 | 0.00265 | 0.00432 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.00254 | -0.00353 | -0.00165 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.248 | 0.143 | 0.428 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.247 | 0.143 | 0.427 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on Double-blind Phase: Ad26.COV2.S 5*10^10 vp than on Double-blind Phase: Placebo | 393 | 283 | 608 | from the risk difference interval | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | Double-blind Phase: Ad26.COV2.S 5*10^10 vp | Participants received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\*10\^10 virus particles (vp) as single dose vaccine on Day 1. | 16 | 19,113 | OG000 | ClinicalTrials.gov |
| Group 2 | Double-blind Phase: Placebo | Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1. | 64 | 18,924 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Participants With First Occurrence of COVID-19 Requiring Medical Intervention (Double Blind Phase) | ClinicalTrials.gov |
| Description | Number of participants with first occurrence of COVID-19 requiring medical intervention (such as a composite endpoint of hospitalization, ICU admission, mechanical ventilation, and ECMO, linked to objective measures such as decreased oxygenation, X-ray or CT findings) or linked to any molecularly confirmed, COVID-19 at least 28 days post vaccination were reported. | ClinicalTrials.gov |
| Time frame | 28 Days after double-blind vaccination on Day 1 (Day 29) | ClinicalTrials.gov |
| Population | PP set included participants of the FAS who received double-blind study vaccine and who were seronegative at the time of double-blind vaccination and who had no other major protocol deviations that were judged to possibly impact the efficacy of the vaccine. Participants who had a positive PCR test between Day 1 and Day 28 in PP set were excluded. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants | ClinicalTrials.gov |
| NCT number | NCT04505722 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19 at Different Stages of the Protocol | ClinicalTrials.gov |
| Interventions | Ad26.COV2.S, Placebo | ClinicalTrials.gov |
| Lead sponsor | Janssen Vaccines & Prevention B.V. | ClinicalTrials.gov |
| Results first posted | 2022-04-15 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT04505722?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.