Double-blind Phase: Ad26.COV2.S 5*10^10 vp vs Double-blind Phase: Placebo: Number of Participants With First Occurrence of Molecularly Confirmed, Moderate to Severe/Critical COVID-19 for Seronegative Participants (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 | 0.0263 | 0.0242 | 0.0285 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0543 | 0.0514 | 0.0574 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.0281 | -0.0318 | -0.0244 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.483 | 0.438 | 0.533 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.469 | 0.424 | 0.52 | 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 | 35.6 | 31.5 | 41 | 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. | 575 | 21,898 | OG000 | ClinicalTrials.gov |
| Group 2 | Double-blind Phase: Placebo | Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1. | 1,189 | 21,890 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Participants With First Occurrence of Molecularly Confirmed, Moderate to Severe/Critical COVID-19 for Seronegative Participants (Double Blind Phase) | ClinicalTrials.gov |
| Description | Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate \>= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate \>= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate \>=30 breaths/minute, heart rate \>=125 beats/minute,SpO2 \<=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance. Seronegative is defined as N-serology seronegative at the time of boosting or at the Year 1 visit if not boosted. | ClinicalTrials.gov |
| Time frame | 1 day after double-blind vaccination on Day 1 (Day 2) | ClinicalTrials.gov |
| Population | FAS included all randomized participants with a documented double-blind study vaccine administration, regardless of the occurrence of protocol deviations and serostatus at enrollment. | 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.