Comparison · NCT04605159-65d291ae
RSV MAT Group - Infant vs Placebo Group - Infant: Number of Infant Participants With at Least One Adverse Event (AE) Leading to Study Withdrawal 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
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ConductScience Library. RSV MAT Group - Infant vs Placebo Group - Infant: Number of Infant Participants With at Least One Adverse Event (AE) Leading to Study Withdrawal From Birth to Day 181 Post-birth. Trial comparisons, record NCT04605159-65d291ae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04605159-65d291ae
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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 | 0.00544 | 0.00348 | 0.00848 | wilson | |
| Risk in group 2 | 0.0023 | 0.000894 | 0.00589 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00314 | -0.000951 | 0.00649 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.37 | 0.806 | 6.95 | log | |
| Odds ratio, group 1 over group 2 | 2.37 | 0.807 | 6.99 | log | |
| Number needed to treat, for one more participant with the outcome on RSV MAT Group - Infant than on Placebo Group - Infant | 318 | 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. | 19 | 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. | 4 | 1,741 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Infant Participants With at Least One Adverse Event (AE) Leading to Study Withdrawal From Birth to Day 181 Post-birth
- Description
A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact. Participants who were withdrawn from the study because of AEs were clearly distinguished from participants who were withdrawn for other reasons. Investigators followed participants who were withdrawn from the study as a result of an AE until the event was resolved. At least one AE leading to study withdrawal = occurrence of at least one AE leading to study withdrawal 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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