Double Blind Phase: Ad26.COV2.S vs Double Blind Phase: Placebo: Double Blind Phase: Number of Participants With Serious Adverse Events (SAEs)
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 | 0.00662 | 0.00547 | 0.00802 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.00872 | 0.00738 | 0.0103 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.0021 | -0.00406 | -0.000166 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.759 | 0.589 | 0.979 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.757 | 0.586 | 0.979 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on Double Blind Phase: Ad26.COV2.S than on Double Blind Phase: Placebo | 476 | 246 | 6,030 | 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 | Participants received a single dose of 0.5 milliliter (mL) adenovirus type 26 vector coronavirus-2 spike protein (Ad26.COV2.S) 5\*10\^10 viral particles (vp) vaccine intramuscularly on Day 1 and Day 57. | 104 | 15,705 | OG000 | ClinicalTrials.gov |
| Group 2 | Double Blind Phase: Placebo | Participants received a single dose of placebo matching to Ad26.COV2.S 5\*10\^10 vp vaccine intramuscularly on Day 1 and Day 57. | 136 | 15,588 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Double Blind Phase: Number of Participants With Serious Adverse Events (SAEs) | ClinicalTrials.gov |
| Description | An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product that does not necessarily have a causal relationship with the vaccine. SAE was any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. | ClinicalTrials.gov |
| Time frame | From Day 1 up to end of double blind phase (7.2 months) | ClinicalTrials.gov |
| Population | FAS post dose 1 population included FAS participants excluding the participants who received a COVID-19 vaccination outside of the study prior to first study vaccination. | 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 Adults | ClinicalTrials.gov |
| NCT number | NCT04614948 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19 | ClinicalTrials.gov |
| Interventions | Ad26.COV2.S, Placebo | ClinicalTrials.gov |
| Lead sponsor | Janssen Vaccines & Prevention B.V. | ClinicalTrials.gov |
| Results first posted | 2024-10-09 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT04614948?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.