Trial · NCT04605159
Outcomes37
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 37
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Infant Participants With Medically Assessed, RSV-associated Lower Respiratory Tract Illnesses (LRTIs) of Any Severity and RSV-associated Severe LRTIs From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Infant Participants With at Least One Serious Adverse Event (SAE) From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Infant Participants With at Least One Adverse Event (AE) Leading to Study Withdrawal From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Infant Participants With at Least One Medically Attended AE (MAE) From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Infant Participants With at Least One SAE From Birth to Day 366 Post-birth | From birth to Day 366 post-birth | The analysis was performed on the Exposed Set for infants, which included the infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Infant Participants With at Least One AE Leading to Study Withdrawal From Birth to Day 366 Post-birth | From birth to Day 366 post-birth | The analysis was performed on the Exposed Set for infants, which included the infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Infant Participants With at Least One MAE From Birth to Day 366 Post-birth | From birth to Day 366 post-birth | The analysis was performed on the Exposed Set for infants, which included the infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Infant Participants With RSV-associated Hospitalizations From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Infant Participants With All-cause LRTIs From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | The analysis was performed on the Modified Full Analysis - Efficacy set for infants, which included all the infant participants in the Exposed Set who were born after at least 4 weeks of their maternal participants vaccination. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Infant Participants With All-cause LRTIs With Hospitalization From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Infant Participants With Medically Assessed, RSV-associated Severe LRTIs From Birth to Day 366 Post-birth | From birth to Day 366 post-birth | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Infant Participants With Medically Assessed, RSV-associated LRTIs of Any Severity From Birth to Day 366 Post-birth | From birth to Day 366 post-birth | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Infant Participants With Medically Assessed, RSV-associated Severe LRTIs for RSV Subtype A and RSV Subtype B Separately From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | The analysis was performed on the Modified Full Analysis - Efficacy set for infants which included all the infant participants in the Exposed Set who were born after at least 4 weeks of their maternal participants vaccination. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Infant Participants With Medically Assessed, RSV-associated LRTIs of Any Severity for RSV Subtype A and RSV Subtype B Separately From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Infant Participants With Medically Assessed, RSV-associated Severe LRTIs From Birth to Day 121 Post-birth | From birth to Day 121 post-birth | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Infant Participants With Medically Assessed, RSV-associated LRTIs of Any Severity From Birth to Day 121 Post-birth | From birth to Day 121 post-birth | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Infant Participants With All-cause Pneumonia From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Infant Participants With RSV-associated Hospitalizations From Birth to Day 366 Post-birth | From birth to Day 366 post-birth | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Maternal Participants With RSV-associated Medically Attended RTIs (RSV-MA-RTIs) From Study Intervention Administration (Day 1) to Day 181 Post-delivery | From study intervention administration (Day 1) to Day 181 post-delivery | The analysis was performed on the Exposed Set for maternal participants, which included all maternal participants who received the study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | RSV-A Neutralizing Antibody Titers for Maternal Participants at Day 1, at Day 31 and at Delivery | At Day 1 (before study intervention administration), at Day 31 and at delivery | The analysis was performed on the Per Protocol - Immunogenicity set for maternal participants, which included all maternal participants who received the study intervention to which they were randomized and had post-vaccination immunogenicity data available for the specified analysis at each of the specified time points (i.e. Day 1, Day 31, delivery) minus those participants with protocol deviations that led to exclusion. | Titers | GEOMETRIC_MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT04605159/outcomes