Comparison · NCT04605159-7eaf17c8
RSV MAT Group - Mother vs Placebo Group - Mother: Number of Maternal Participants With Any Unsolicited AEs From Day 1 to Day 30 Included
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. RSV MAT Group - Mother vs Placebo Group - Mother: Number of Maternal Participants With Any Unsolicited AEs From Day 1 to Day 30 Included. Trial comparisons, record NCT04605159-7eaf17c8. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04605159-7eaf17c8
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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 | 0.177 | 0.165 | 0.19 | wilson | |
| Risk in group 2 | 0.168 | 0.151 | 0.186 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00913 | -0.0127 | 0.0302 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.05 | 0.93 | 1.2 | log | |
| Odds ratio, group 1 over group 2 | 1.07 | 0.916 | 1.24 | log | |
| Number needed to treat, for one more participant with the outcome on RSV MAT Group - Mother than on Placebo Group - Mother | 109 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | RSV MAT Group - Mother | Maternal participants received a single dose of the RSV MAT vaccine administered at Day 1 in this study. | 629 | 3,557 | OG000 |
| Group 2 | Placebo Group - Mother | Maternal participants received a single dose of placebo administered at Day 1 in this study. | 297 | 1,771 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Maternal Participants With Any Unsolicited AEs From Day 1 to Day 30 Included
- Description
An unsolicited AE is defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Any = occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
- Time frame
- From Day 1 to Day 30 included
- Population
- The analysis was performed on the Exposed Set for maternal participants, which included all maternal participants who received the study intervention.
Source ClinicalTrials.gov
Trial
- Title
- A Phase III, Double-blind Study to Assess Safety and Efficacy of an RSV Maternal Unadjuvanted Vaccine, in Pregnant Women and Infants Born to Vaccinated Mothers
- NCT number
- NCT04605159
- Phases
- PHASE3
- Conditions
- Respiratory Syncytial Virus Infections
- Interventions
- RSV MAT, Placebo
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2024-09-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04605159?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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