Trial · NCT05437510
Study of a Single Intramuscular Dose of Nirsevimab in the Prevention of Hospitalizations Due to Respiratory Syncytial Virus (RSV) Infection in Healthy Term and Preterm Infants During the First Year of Life
NCT05437510, Phase 3, Completed, Sanofi Pasteur, a Sanofi Company; results first posted 2025-04-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of a Single Intramuscular Dose of Nirsevimab in the Prevention of Hospitalizations Due to Respiratory Syncytial Virus (RSV) Infection in Healthy Term and Preterm Infants During the First Year of Life. Trials, record NCT05437510. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05437510
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study of a Single Intramuscular Dose of Nirsevimab in the Prevention of Hospitalizations Due to Respiratory Syncytial Virus (RSV) Infection in Healthy Term and Preterm Infants During the First Year of Life
- NCT number
- NCT05437510
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 8,057 participants, actual
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Conditions
- RSV Immunization, Healthy Volunteer
- Interventions
- Nirsevimab
- First posted
- 2022-06-29
- Last updated
- 2025-10-09
- Other registries' IDs
- eudract:2022-000099-20
- Results first posted
- 2025-04-11
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | LRTI included the following common symptoms: clinical finding of rhonchi, rales, crackles, or wheeze; increased respiratory rate at rest (age: \<2 months, ≥60 breaths per minute (/min); 2 to 6 months, ≥50 breaths/min; \>6 months, ≥40 breaths/min), and hypoxemia (in room air: oxygen saturation \<95%). Hospitalization was defined as the decision to admit to in-patient care by the treating physician. RSV season was the period of increased RSV infection. |
| 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 | LRTI included the following common symptoms: clinical finding of rhonchi, rales, crackles, or wheeze; increased respiratory rate at rest (age: \<2 months, ≥60 breaths/min; 2 to 6 months, ≥50 breaths/min; \>6 months, ≥40 breaths/min), and hypoxemia (in room air: oxygen saturation \<95%). Very severe RSV LRTI was defined as RSV LRTI hospitalization with oxygen saturation \<90% (at any time during hospitalization) and oxygen supplementation. Hospitalization was defined as the decision to admit to in-patient care by the treating physician. RSV season was the period of increased RSV infection. |
| 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 | LRTI included the following common symptoms: clinical finding of rhonchi, rales, crackles, or wheeze; increased respiratory rate at rest (age: \<2 months, ≥60 breaths/min; 2 to 6 months, ≥50 breaths/min; \>6 months, ≥40 breaths/min), and hypoxemia (in room air: oxygen saturation \<95%). Hospitalization was defined as the decision to admit to in-patient care by the treating physician. RSV season was the period of increased RSV infection. Number of participants with RSV LRTI hospitalization through the RSV season in France, UK, and Germany is presented. |
| 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 | LRTI included the following common symptoms: clinical finding of rhonchi, rales, crackles, or wheeze; increased respiratory rate at rest (age: \<2 months, ≥60 breaths/min; 2 to 6 months, ≥50 breaths/min; \>6 months, ≥40 breaths/min), and hypoxemia (in room air: oxygen saturation \<95%). Hospitalization was defined as the decision to admit to in-patient care by the treating physician. RSV season was the period of increased RSV infection. Number of participants with hospitalization for all-cause LRTI through the RSV season in France, UK, Germany, and overall is presented. |
| 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 | LRTI included the following common symptoms: clinical finding of rhonchi, rales, crackles, or wheeze; increased respiratory rate at rest (age: \<2 months, ≥60 breaths/min; 2 to 6 months, ≥50 breaths/min; \>6 months, ≥40 breaths/min), and hypoxemia (in room air: oxygen saturation \<95%). Hospitalization was defined as the decision to admit to in-patient care by the treating physician. Number of participants with RSV LRTI hospitalization through 151 days post-dosing/randomization in France, UK, Germany, and overall is presented. |
| 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 | LRTI included the following common symptoms: clinical finding of rhonchi, rales, crackles, or wheeze; increased respiratory rate at rest (age: \<2 months, ≥60 breaths/min; 2 to 6 months, ≥50 breaths/min; \>6 months, ≥40 breaths/min), and hypoxemia (in room air: oxygen saturation \<95%). Very severe RSV LRTI was defined as RSV LRTI hospitalization with oxygen saturation \<90% (at any time during hospitalization) and oxygen supplementation. Hospitalization was defined as the decision to admit to in-patient care by the treating physician. Number of participants with very severe RSV LRTI through 151 days post-dosing/randomization in France, UK, Germany, and overall is presented. |
| 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 | LRTI included the following common symptoms: clinical finding of rhonchi, rales, crackles, or wheeze; increased respiratory rate at rest (age: \<2 months, ≥60 breaths/min; 2 to 6 months, ≥50 breaths/min; \>6 months, ≥40 breaths/min), and hypoxemia (in room air: oxygen saturation \<95%). Hospitalization was defined as the decision to admit to in-patient care by the treating physician. Number of participants with hospitalization for all-cause LRTI through 151 days post-dosing/randomization in France, UK, Germany, and overall is presented. |
| Secondary | Number of Participants With Immediate Treatment-Emergent Adverse Events (TEAEs) | Up to 30 minutes post-dosing/randomization on Day 1 | An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were either events with the start date and time posterior to the start of the treatment period and up to the end of the treatment period or events with the start date and time prior to the start of the treatment period, whose severity was greater than 1 or missing and stop date is missing or not before the treatment period. Immediate events were recorded to capture medically relevant AEs which occurred within the first 30 minutes after immunization. |
| Secondary | Number of Participants With Non-Serious Treatment-Emergent Adverse Events | From dosing/randomization (Day 1) to Day 31 | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were either events with the start date and time posterior to the start of the treatment period and up to the end of the treatment period or events with the start date and time prior to the start of the treatment period, whose severity was greater than 1 or missing and stop date was missing or not before the treatment period. |
| 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 | AE: untoward medical occurrence in clinical study participant, temporally associated with use of study intervention, whether or not related to it. TEAEs: events with start date/time posterior to start of treatment period(TP) and up to end of TP, or events with start date/time prior to start of TP, whose severity was\>1/missing; stop date was missing/not before TP. SAE: AE at any dose resulting in death, persistent or significant disability/incapacity, required inpatient hospitalization/prolongation of existing hospitalization, was life-threatening or congenital anomaly/birth defect or medically important event. MAAE: new onset/worsening of condition that prompted participant or participant's parent/legally acceptable representative to seek unplanned medical advice at physician's office/Emergency Department. AESI: scientific, medical concern specific to Sponsor's study intervention/program for which ongoing monitoring and rapid communication by investigator to Sponsor was appropriate. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group86
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI) Hospitalization Through the Respiratory Syncytial Virus Season | Nirsevimab | 11 | Participants | ||
| Number of Participants With Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI) Hospitalization Through the Respiratory Syncytial Virus Season | No Intervention | 64 | Participants | ||
| Number of Participants With Very Severe Respiratory Syncytial Virus Lower Respiratory Tract Infection Through the Respiratory Syncytial Virus Season | Nirsevimab | 5 | Participants | ||
| Number of Participants With Very Severe Respiratory Syncytial Virus Lower Respiratory Tract Infection Through the Respiratory Syncytial Virus Season | No Intervention | 21 | Participants | ||
| Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization Through the Respiratory Syncytial Virus Season in Each Country | Nirsevimab | France | 3 | Participants | |
| Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization Through the Respiratory Syncytial Virus Season in Each Country | No Intervention | France | 28 | Participants | |
| Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization Through the Respiratory Syncytial Virus Season in Each Country | Nirsevimab | United Kingdom | 3 | Participants | |
| Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization Through the Respiratory Syncytial Virus Season in Each Country | No Intervention | United Kingdom | 17 | Participants | |
| Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization Through the Respiratory Syncytial Virus Season in Each Country | Nirsevimab | Germany | 5 | Participants | |
| Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization Through the Respiratory Syncytial Virus Season in Each Country | No Intervention | Germany | 19 | Participants |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nirsevimab | 4,038 | |
| Overall Study | STARTED | No Intervention | 4,019 | |
| Overall Study | Randomized and Treated | Nirsevimab | 4,015 | |
| Overall Study | Randomized and Treated | No Intervention | 1 | |
| Overall Study | Participants Entered Study Extension | Nirsevimab | 1,142 | |
| Overall Study | Participants Entered Study Extension | No Intervention | 1,084 | |
| Overall Study | COMPLETED | Nirsevimab | 3,747 | |
| Overall Study | COMPLETED | No Intervention | 3,631 | |
| Overall Study | NOT COMPLETED | Nirsevimab | 291 | |
| Overall Study | NOT COMPLETED | No Intervention | 388 |
Source ClinicalTrials.gov
Adverse events472
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Nirsevimab | 324 | 4,016 | 345 |
| other | Nasopharyngitis | Infections and infestations | No Intervention | 279 | 4,018 | 298 |
| serious | Accidental Exposure To Product | Injury, poisoning and procedural complications | Nirsevimab | 1 | 4,016 | 1 |
| serious | Accidental Exposure To Product | Injury, poisoning and procedural complications | No Intervention | 0 | 4,018 | 0 |
| serious | Clavicle Fracture | Injury, poisoning and procedural complications | Nirsevimab | 1 | 4,016 | 1 |
| serious | Clavicle Fracture | Injury, poisoning and procedural complications | No Intervention | 0 | 4,018 | 0 |
| serious | Concussion | Injury, poisoning and procedural complications | Nirsevimab | 3 | 4,016 | 4 |
| serious | Concussion | Injury, poisoning and procedural complications | No Intervention | 5 | 4,018 | 5 |
| serious | Contusion | Injury, poisoning and procedural complications | Nirsevimab | 2 | 4,016 | 2 |
| serious | Contusion | Injury, poisoning and procedural complications | No Intervention | 1 | 4,018 | 1 |
1 to 10 of 472Source ClinicalTrials.gov
See all 472 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nirsevimab | 1 | 4,016 |
| Total, all-cause mortality | No Intervention | 0 | 4,018 |
| Total, other adverse events | Nirsevimab | 324 | 4,016 |
| Total, other adverse events | No Intervention | 279 | 4,018 |
| Total, serious adverse events | Nirsevimab | 262 | 4,016 |
| Total, serious adverse events | No Intervention | 222 | 4,018 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons11
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Nirsevimab vs No Intervention: Number of Participants With Very Severe Respiratory Syncytial Virus Lower Respiratory Tract Infection Through the Respiratory Syncytial Virus Season | Trial comparisons |
| Nirsevimab vs No Intervention: Number of Participants With Immediate Treatment-Emergent Adverse Events (TEAEs) | Trial comparisons |
| Nirsevimab vs No Intervention: Number of Participants With Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI) Hospitalization Through the Respiratory Syncytial Virus Season | Trial comparisons |
Nirsevimab vs No Intervention: 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) | Trial comparisons |
Nirsevimab vs No Intervention: 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) | Trial comparisons |
| Nirsevimab vs No Intervention: Number of Participants With Recurrent Wheeze (for United Kingdom Reconsented Participants) | Trial comparisons |
| Nirsevimab vs No Intervention: Number of Participants With Non-Serious Treatment-Emergent Adverse Events | Trial comparisons |
| Nirsevimab vs No Intervention: Number of Participants With Hospitalization for All-Cause Lower Respiratory Tract Infection From Days 181 to 366 Post-dosing/Randomization | Trial comparisons |
| Nirsevimab vs No Intervention: deaths from any cause | Trial comparisons |
| Nirsevimab vs No Intervention: Number of Participants With Treatment-Related Serious Adverse Event (for United Kingdom Reconsented Participants) | Trial comparisons |
1 to 10 of 11
See all 11 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05437510
GET https://conductscience.org/api/trials/v1/NCT05437510/results?page=2