Double-blind Phase: Ad26.COV2.S 5*10^10 vp vs Double-blind Phase: Placebo: Number of Participants With Medically-Attended Adverse Events (MAAEs) (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 | 0.0764 | 0.0729 | 0.08 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0861 | 0.0825 | 0.0899 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.00978 | -0.0149 | -0.00466 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.887 | 0.832 | 0.944 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.877 | 0.819 | 0.939 | 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 | 102 | 67.1 | 215 | 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. | 1,672 | 21,894 | OG000 | ClinicalTrials.gov |
| Group 2 | Double-blind Phase: Placebo | Participants received IM injection of placebo matching to Ad26.COV2.S on Day 1. | 1,885 | 21,882 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Participants With Medically-Attended Adverse Events (MAAEs) (Double Blind Phase) | ClinicalTrials.gov |
| Description | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. | ClinicalTrials.gov |
| Time frame | Up to 6 months after double-blind vaccination on Day 1 (up to 6 months) | 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. Here N (Overall number of participants analyzed) signifies participants evaluated for this outcome measure. | 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.