Trial · NCT05437510
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI) Hospitalization Through the Respiratory Syncytial Virus Season | From dosing/randomization (Day 1) up to approximately 7 months | The All Randomized Set consisted of all participants randomly assigned to either the nirsevimab group or the no intervention group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Very Severe Respiratory Syncytial Virus Lower Respiratory Tract Infection Through the Respiratory Syncytial Virus Season | From dosing/randomization (Day 1) up to approximately 7 months | The All Randomized Set consisted of all participants randomly assigned to either the nirsevimab group or the no intervention group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization Through the Respiratory Syncytial Virus Season in Each Country | From dosing/randomization (Day 1) up to approximately 7 months | The All Randomized Set consisted of all participants randomly assigned to either the nirsevimab group or the no intervention group. 'Number Analyzed' indicates the number of participants with data collected for each specified category. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Hospitalization for All-Cause Lower Respiratory Tract Infection Through the Respiratory Syncytial Virus Season | From dosing/randomization (Day 1) up to approximately 7 months | The All Randomized Set consisted of all participants randomly assigned to either the nirsevimab group or the no intervention group. 'Number Analyzed' indicates the number of participants with data collected for each specified category. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization Through 151 Days Post-dosing/Randomization | From dosing/randomization (Day 1) to Day 151 | The All Randomized Set consisted of all participants randomly assigned to either the nirsevimab group or the no intervention group. 'Number Analyzed' indicates the number of participants with data collected for each specified category. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Very Severe Respiratory Syncytial Virus Lower Respiratory Tract Infection Through 151 Days Post-dosing/Randomization | From dosing/randomization (Day 1) to Day 151 | The All Randomized Set consisted of all participants randomly assigned to either the nirsevimab group or the no intervention group. 'Number Analyzed' indicates the number of participants with data collected for each specified category. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Hospitalization for All-Cause Lower Respiratory Tract Infection Through 151 Days Post-dosing/Randomization | From dosing/randomization (Day 1) to Day 151 | The All Randomized Set consisted of all participants randomly assigned to either the nirsevimab group or the no intervention group. 'Number Analyzed' indicates the number of participants with data collected for each specified category. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Immediate Treatment-Emergent Adverse Events (TEAEs) | Up to 30 minutes post-dosing/randomization on Day 1 | The Safety Analysis Set (SafAS) consisted of all participants who received nirsevimab in the study and all randomized participants who were randomized to the no intervention group and did not receive nirsevimab inadvertently. As pre-specified in the protocol and SAP, results are presented by treatment group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Non-Serious Treatment-Emergent Adverse Events | From dosing/randomization (Day 1) to Day 31 | The SafAS consisted of all participants who received nirsevimab in the study and all randomized participants who were randomized to the no intervention group and did not receive nirsevimab inadvertently. As pre-specified in the protocol and SAP, results are presented by treatment group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events of Special Interest (AESIs) and Treatment-Emergent Medically Attended Adverse Events (MAAEs) | From dosing/randomization (Day 1) to Day 366 | The SafAS consisted of all participants who received nirsevimab in the study and all randomized participants who were randomized to the no intervention group and did not receive nirsevimab inadvertently. As pre-specified in the protocol and SAP, results are presented by treatment group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-Related Serious Adverse Event (for United Kingdom Reconsented Participants) | From Day 366 to Day 731 | The SafAS consisted of all participants who received nirsevimab in the study and all randomized participants who were randomized to the no intervention group and did not receive nirsevimab inadvertently. As pre-specified in the protocol and SAP, results are presented by treatment group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization Through 181 Days Post-dosing/Randomization | From dosing/randomization (Day 1) to Day 181 | The All Randomized Set consisted of all participants randomly assigned to either the nirsevimab group or the no intervention group. 'Number Analyzed' indicates the number of participants with data collected for each specified category. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Hospitalization for All-Cause Lower Respiratory Tract Infection Through 181 Days Post-dosing/Randomization | From dosing/randomization (Day 1) to Day 181 | The All Randomized Set consisted of all participants randomly assigned to either the nirsevimab group or the no intervention group. 'Number Analyzed' indicates the number of participants with data collected for each specified category. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization From Days 181 to 366 Post-dosing/Randomization | From Day 181 to Day 366 | The All Randomized Set consisted of all participants randomly assigned to either the nirsevimab group or the no intervention group. Only participants with data collected are reported. 'Number Analyzed' indicates the number of participants with data collected for each specified category. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Hospitalization for All-Cause Lower Respiratory Tract Infection From Days 181 to 366 Post-dosing/Randomization | From Day 181 to Day 366 | The All Randomized Set consisted of all participants randomly assigned to either the nirsevimab group or the no intervention group. Only participants with data collected are reported. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization From Days 366 to 731 Post-dosing/Randomization (for United Kingdom Reconsented Participants) | From Day 366 to Day 731 | The All Randomized Set consisted of all participants randomly assigned to either the nirsevimab group or the no intervention group. Only participants with data collected are reported. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Hospitalization for All-Cause Lower Respiratory Tract Infection From Days 366 to 731 Post-dosing/Randomization (for United Kingdom Reconsented Participants) | From Day 366 to Day 731 | The All Randomized Set consisted of all participants randomly assigned to either the nirsevimab group or the no intervention group. Only participants with data collected are reported. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Recurrent Wheeze (for United Kingdom Reconsented Participants) | From dosing/randomization (Day 1) to Day 731 | The All Randomized Set consisted of all participants randomly assigned to either the nirsevimab group or the no intervention group. Only participants with data collected are reported. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT05437510/outcomes