Comparison · NCT04605159-538e8f1b
RSV MAT Group - Infant vs Placebo Group - Infant: Number of Infant Participants With at Least One Serious Adverse Event (SAE) From Birth to Day 181 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 at Least One Serious Adverse Event (SAE) From Birth to Day 181 Post-birth. Trial comparisons, record NCT04605159-538e8f1b. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04605159-538e8f1b
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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 | 0.183 | 0.171 | 0.196 | wilson | |
| Risk in group 2 | 0.186 | 0.168 | 0.204 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00235 | -0.025 | 0.0196 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.987 | 0.875 | 1.11 | log | |
| Odds ratio, group 1 over group 2 | 0.984 | 0.849 | 1.14 | log | |
| Number needed to treat, for one fewer participant with the outcome on RSV MAT Group - Infant than on Placebo Group - Infant | 425 | 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. | 640 | 3,494 | 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. | 323 | 1,741 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Infant Participants With at Least One Serious Adverse Event (SAE) From Birth to Day 181 Post-birth
- Description
An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect or resulted in other situations that were considered serious per medical or scientific judgment. At least one SAE = occurrence of at least one SAE regardless of intensity grade or relation to vaccination.
- Time frame
- From birth to Day 181 post-birth
- Population
The analysis was performed on the Exposed Set for infants, which included the infants live-born to exposed maternal participants, whose parents/legally acceptable representative(s) (LARs) completed the informed consent process and signed the informed consent form.
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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