Group 1: Ad26.RSV.preF and RSV preF Protein vs Group 2: Placebo: deaths from any cause
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 | 0.00628 | 0.00519 | 0.0076 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.00729 | 0.00568 | 0.00935 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.00101 | -0.00334 | 0.00107 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.862 | 0.629 | 1.18 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.861 | 0.627 | 1.18 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer death from any cause on Group 1: Ad26.RSV.preF and RSV preF Protein than on Group 2: Placebo | 994 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | Group 1: Ad26.RSV.preF and RSV preF Protein | Participants received a single intramuscular (IM) injection containing a mixture of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) at a dose of 1\*10\^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) on Day 1. | 105 | 16,709 | EG000 | ClinicalTrials.gov |
| Group 2 | Group 2: Placebo | Participants received a single IM injection of matching placebo on Day 1. | 61 | 8,367 | EG001 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, all-cause mortality | ClinicalTrials.gov |
| Time frame | From Day 1 up to 24 months post-vaccination on Day 1 (Day 731). | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older | ClinicalTrials.gov |
| NCT number | NCT04908683 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Respiratory Syncytial Viruses, Lower Respiratory Tract Disease | ClinicalTrials.gov |
| Interventions | Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF, Placebo | ClinicalTrials.gov |
| Lead sponsor | Janssen Vaccines & Prevention B.V. | ClinicalTrials.gov |
| Results first posted | 2024-02-08 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT04908683?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.