RSVPreF3 Group vs Placebo Group: Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Lower Respiratory Tract Disease (LRTD) During the First Season Following a Single Dose of the RSVPreF3 OA Vaccine
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 | 0.000562 | 0.000272 | 0.00116 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0032 | 0.00235 | 0.00436 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.00264 | -0.00383 | -0.0016 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.175 | 0.0786 | 0.391 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.175 | 0.0783 | 0.391 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on RSVPreF3 Group than on Placebo Group | 379 | 261 | 624 | 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 | RSVPreF3 Group | Participants received a single dose of the RSVPreF3 OA vaccine at Day 1. Before the second vaccination participants in this group were re-randomized into 2 as: a group that received placebo every subsequent year, and a group that received an additional dose of RSVPreF3 OA vaccine every subsequent year of the study. | 7 | 12,466 | OG000 | ClinicalTrials.gov |
| Group 2 | Placebo Group | Participants received 1 dose of placebo at Day 1 and an additional dose of placebo every subsequent year of the study. | 40 | 12,494 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | PRIMARY | ClinicalTrials.gov |
| Title | Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Lower Respiratory Tract Disease (LRTD) During the First Season Following a Single Dose of the RSVPreF3 OA Vaccine | ClinicalTrials.gov |
| Description | First episode of Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated LRTD during the first season was assessed. The case definition for RSV-confirmed LRTD is as follows: Presence of at least one RSV-positive swab detected by RT-PCR. | ClinicalTrials.gov |
| Time frame | From Day 15 post-vaccination up to end of season 1 in the Northern Hemisphere (NH) [a median of approximately 6.7 months (6.9 months in NH and 3.5 months in Southern Hemisphere [SH])] | ClinicalTrials.gov |
| Population | Analysis was performed on the modified Exposed Set (mES), which included all participants who received at least the first dose of the study intervention and who do not report an RSV-confirmed Acute Respiratory Illness (ARI) prior to 2 weeks (\<Day 15) after each vaccination (mES-RSV set). Only participants with data available at specified timepoints were included in analysis. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above | ClinicalTrials.gov |
| NCT number | NCT04886596 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Respiratory Syncytial Virus Infections | ClinicalTrials.gov |
| Interventions | Placebo, RSVPreF3 OA vaccine | ClinicalTrials.gov |
| Lead sponsor | GlaxoSmithKline | ClinicalTrials.gov |
| Results first posted | 2023-08-04 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT04886596?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.