Group 1: Ad26.RSV.preF and RSV preF Protein vs Group 2: Placebo: Number of Participants With First Occurrence of Predefined Clinically Relevant Disease Associated With RT-PCR-Confirmed RSV-Mediated ARI Over the Whole Study
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 | 0.000246 | 0.0000957 | 0.000632 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.00135 | 0.000754 | 0.00241 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.0011 | -0.00218 | -0.000393 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.182 | 0.0581 | 0.572 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.182 | 0.058 | 0.572 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on Group 1: Ad26.RSV.preF and RSV preF Protein than on Group 2: Placebo | 906 | 459 | 2,540 | 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 | 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. | 4 | 16,263 | OG000 | ClinicalTrials.gov |
| Group 2 | Group 2: Placebo | Participants received a single IM injection of matching placebo on Day 1. | 11 | 8,152 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Participants With First Occurrence of Predefined Clinically Relevant Disease Associated With RT-PCR-Confirmed RSV-Mediated ARI Over the Whole Study | ClinicalTrials.gov |
| Description | A participant was considered to have clinically relevant disease with specific parameters associated with an RT-PCR-confirmed RSV-mediated ARI if the following criteria were met: the participant had an RT-PCR-confirmed RSV-mediated ARI: ARI episode initiated by the participant and confirmed by the site with symptoms consistent with an ARI (new symptoms or worsening from baseline of at least one of the symptoms as captured on the RiiQ): sore throat, nasal congestion, cough, short of breath, coughing up phlegm (sputum), wheezing and confirmation of RSV by RT-PCR in one or more of the nasal swabs, or in the sputum sample; any of the following associated with ARI: hospitalization, emergency department visit, per clinical judgement of complications, decreased oxygen saturation, tachypnea, need of supplemental oxygen, hypotension, pulmonary function test and arterial blood gas result. | ClinicalTrials.gov |
| Time frame | Baseline (Day 1) up to 24 months | ClinicalTrials.gov |
| Population | PPE population is defined as population included all randomized and vaccinated participants, excluding those with MPDs expecting to impact the efficacy outcomes. Participants with an RSV onset within 14 days after vaccination and participants who discontinued within 14 days after vaccination were excluded from the PPE population. | 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.