Comparison · NCT04605159-c188af5e
RSV MAT Group - Infant vs Placebo Group - Infant: Number of Infant Participants With Medically Assessed, RSV-associated Severe LRTIs From Birth to Day 366 Post-birth
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. RSV MAT Group - Infant vs Placebo Group - Infant: Number of Infant Participants With Medically Assessed, RSV-associated Severe LRTIs From Birth to Day 366 Post-birth. Trial comparisons, record NCT04605159-c188af5e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04605159-c188af5e
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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 | 0.0111 | 0.00809 | 0.0152 | wilson | |
| Risk in group 2 | 0.0129 | 0.00851 | 0.0194 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00177 | -0.00896 | 0.00421 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.863 | 0.512 | 1.45 | log | |
| Odds ratio, group 1 over group 2 | 0.861 | 0.508 | 1.46 | log | |
| Number needed to treat, for one fewer participant with the outcome on RSV MAT Group - Infant than on Placebo Group - Infant | 566 | 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 - Infant | This group consisted of infants born to mothers (from RSV MAT Group - Mother) who received a single dose of RSV MAT vaccine during pregnancy. | 38 | 3,426 | OG000 |
| Group 2 | Placebo Group - Infant | This group consisted of infants born to mothers (from Placebo Group - Mother) who received a single dose of placebo during pregnancy. | 22 | 1,711 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Infant Participants With Medically Assessed, RSV-associated Severe LRTIs From Birth to Day 366 Post-birth
- Description
An RSV-associated LRTI of any severity was characterized by a history of cough OR difficulty in breathing, AND an SpO2 \<95%, OR respiratory rate increase AND a confirmed RSV infection. An RSV-associated severe LRTI met the case definition of RSV-LRTI AND was additionally characterized by an SpO2 \<93%, OR lower chest wall in-drawing, OR inability to feed, OR failure to respond/unconscious. Medically assessed = the infant was evaluated by a healthcare professional for the LRTI.
- Time frame
- From birth to Day 366 post-birth
- Population
The analysis was performed on the Modified Full Analysis - Efficacy set for infants, which included all infant participants in the Exposed Set who were born after at least 4 weeks of their maternal participants vaccination.
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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