Double Blind Phase: Ad26.COV2.S vs Double Blind Phase: Placebo: Double Blind Phase: Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 in Seronegative Participants With Onset at Least 14 Days After the Second Vaccination
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 | 0.00232 | 0.00138 | 0.0039 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.00926 | 0.00707 | 0.0121 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.00694 | -0.00995 | -0.00424 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.251 | 0.139 | 0.452 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.249 | 0.138 | 0.45 | 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 | 144 | 101 | 236 | 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. | 14 | 6,024 | 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. | 52 | 5,615 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | PRIMARY | ClinicalTrials.gov |
| Title | Double Blind Phase: Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 in Seronegative Participants With Onset at Least 14 Days After the Second Vaccination | ClinicalTrials.gov |
| Description | Molecularly confirmed moderate to severe/critical COVID-19 was defined as a severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) positive reverse transcription/polymerase chain reaction (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 (min) and symptoms such as shortness of breath or two signs or symptoms such as heart rate \>=90 beats/min 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/min, heart rate \>=125 beats/min, oxygen saturation (SpO2) \<=93 percent (%) on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to Intensive Care Unit (ICU), death defined as per FDA guidance. | ClinicalTrials.gov |
| Time frame | From at least 14 days after second vaccination on Day 57 (Day 71) up to end of double blind phase (7.2 months) | ClinicalTrials.gov |
| Population | Per-protocol efficacy (PP) set: participants in FAS who received 2 doses of DB study vaccine, were PCR negative at time of first vaccination, were seronegative at time of first vaccination and at 14 days after second vaccination and had no other major protocol deviations to possibly impact efficacy of vaccine before unblinding. Participants who had a positive PCR test between Day 1 and Day 70 and participants who discontinued prior to 14 days post-dose 2 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 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.