Comparison · NCT03982199-fd0cd479
Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture) vs Arm 2: Main Cohort: Group 2: Placebo: Main Cohorts: Number of Participants With Solicited Systemic AEs up to 7 Days After First Vaccination
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture) vs Arm 2: Main Cohort: Group 2: Placebo: Main Cohorts: Number of Participants With Solicited Systemic AEs up to 7 Days After First Vaccination. Trial comparisons, record NCT03982199-fd0cd479. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03982199-fd0cd479
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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 | 0.419 | 0.368 | 0.472 | wilson | |
| Risk in group 2 | 0.174 | 0.137 | 0.218 | wilson | |
| Risk difference, group 1 minus group 2 | 0.246 | 0.178 | 0.31 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.41 | 1.85 | 3.15 | log | |
| Odds ratio, group 1 over group 2 | 3.44 | 2.41 | 4.9 | log | |
| Number needed to treat, for one more participant with the outcome on Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture) than on Arm 2: Main Cohort: Group 2: Placebo | 4.07 | 3.22 | 5.62 | 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 | Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture) | Adult participants aged greater than or equal to (\>=) 65 years received a single intramuscular (IM) injection of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F-protein (Ad26.RSV.preF) 1\*10\^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) (protein mixture) on Day 1. Participants were divided into revaccination subcohorts: 1A, 1B, and 1C. Participants further received revaccination with the Ad26.RSV.preF 1\*10\^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 1A), 2 (Subcohort 1B), and 3 (Subcohort 1C) years, respectively after the first vaccination on Day 1. Participants who were not re-vaccinated continued in the main cohort and were followed up for safety assessments until Day 1095. | 143 | 341 | OG000 |
| Group 2 | Arm 2: Main Cohort: Group 2: Placebo | Adult participants aged \>=65 years received a single IM injection of placebo on Day 1. Participants were divided into revaccination subcohorts: 2A, 2B, and 2C. Participants further received revaccination with Ad26.RSV.preF 1\*10\^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 2A), 2 (Subcohort 2B), and 3 (Subcohort 2C) years, respectively after the first vaccination on Day 1. Participants in subcohorts 2A and 2B were additionally re-randomised in three groups at Year 3 and Year 4, respectively, to receive either Ad26.RSV.preF 1\*10\^11 vp alone, RSV preF protein 150 mcg alone or the Ad26.RSV.preF 1\*10\^11 vp and RSV preF protein 150 mcg (protein mixture). Participants who were not re-vaccinated continued in the main cohort and were followed up for safety assessments until Day 1095. | 58 | 334 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Main Cohorts: Number of Participants With Solicited Systemic AEs up to 7 Days After First Vaccination
- Description
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, arthralgia, and fever (defined as an endogenous elevation of body temperature \>=38.0°C, as recorded in at least one measurement).
- Time frame
- Up to Day 8 (7 days after first vaccination on Day 1)
- Population
The safety subset included all participants that consented to the collection of AEs (solicited AEs for up to 7 days after vaccination and unsolicited AEs for 28 days after vaccination). Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Source ClinicalTrials.gov
Trial
- Title
A Study of an Ad26.RSV.preF-based Regimen in the Prevention of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV)-Mediated Lower Respiratory Tract Disease in Adults Aged 65 Years and Older
- NCT number
- NCT03982199
- Phases
- PHASE2
- Conditions
- Respiratory Syncytial Viruses, Respiratory Tract Diseases
- Interventions
- RSV Vaccine, Placebo
- Lead sponsor
- Janssen Vaccines & Prevention B.V.
- Results first posted
- 2023-07-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03982199?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.govNone 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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