Comparison · NCT04908683-52bc4bff
Group 1: Ad26.RSV.preF and RSV preF Protein vs Group 2: Placebo: Number of Participants With Solicited Systemic AEs up to 7 Days After Vaccination
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Group 1: Ad26.RSV.preF and RSV preF Protein vs Group 2: Placebo: Number of Participants With Solicited Systemic AEs up to 7 Days After Vaccination. Trial comparisons, record NCT04908683-52bc4bff. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04908683-52bc4bff
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.442 | 0.421 | 0.462 | wilson | |
| Risk in group 2 | 0.204 | 0.182 | 0.229 | wilson | |
| Risk difference, group 1 minus group 2 | 0.237 | 0.206 | 0.267 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.16 | 1.91 | 2.44 | log | |
| Odds ratio, group 1 over group 2 | 3.08 | 2.61 | 3.63 | log | |
| Number needed to treat, for one more participant with the outcome on Group 1: Ad26.RSV.preF and RSV preF Protein than on Group 2: Placebo | 4.21 | 3.74 | 4.86 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| 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. | 1,018 | 2,305 | OG000 |
| Group 2 | Group 2: Placebo | Participants received a single IM injection of matching placebo on Day 1. | 236 | 1,155 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Solicited Systemic AEs up to 7 Days After Vaccination
- Description
Number of participants with solicited systemic AEs 7 days post vaccination were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited systemic AEs included fatigue, headache, myalgia, nausea, pyrexia, for which participants were specifically questioned and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
- Time frame
- Up to Day 7 post vaccination on Day 1 (up to Day 8)
- Population
The safety subset (a subset of FAS) included all participants that consented to the collection of AEs (solicited AEs for up to 7 days after vaccination). Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Source ClinicalTrials.gov
Trial
- 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
- NCT number
- NCT04908683
- Phases
- PHASE3
- Conditions
- Respiratory Syncytial Viruses, Lower Respiratory Tract Disease
- Interventions
- Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF, Placebo
- Lead sponsor
- Janssen Vaccines & Prevention B.V.
- Results first posted
- 2024-02-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04908683?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- 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
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone 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.
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