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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1272-2514 | Registry Identifier | ICTRP | |
| 2022-000099-20 | EudraCT Number |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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The purpose of this study was to determine the efficacy and safety of a single intramuscular (IM) dose of nirsevimab, compared to no intervention, for the prevention of hospitalizations due to lower respiratory tract infection (LRTI) caused by confirmed RSV infection (henceforth referred to as RSV LRTI hospitalizations) in all infants under 12 months of age who were not eligible to receive palivizumab.
The visit frequency was 1 in-person dosing/randomization visit, with monthly safety follow-up electronic contacts through the first 6 months post dosing/randomization for all participants. The study also included a 12-month (Day 366) follow-up telephone call. The D366 follow-up telephone call was the final follow-up telephone call for France, Germany and UK non-reconsented participants. The study included an 18-month (D546) and a 24-month (D731, final telephone call) follow-up telephone call for UK reconsented participants.
12 months post-dosing/randomization for France, Germany and UK non-reconsented participants, 24 months post-dosing/randomization for UK reconsented participants. D01 was the day of randomization (both study groups) and immunization (nirsevimab group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nirsevimab | Experimental | 1 intramuscular injection at Day 01 |
|
| No preventive intervention for RSV | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nirsevimab | Biological | Pharmaceutical Form: Solution for Injection Route of Administration: Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI) Hospitalization Through the Respiratory Syncytial Virus Season | 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. | From dosing/randomization (Day 1) up to approximately 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Very Severe Respiratory Syncytial Virus Lower Respiratory Tract Infection Through the Respiratory Syncytial Virus Season | 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. |
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Inclusion Criteria:
Exclusion Criteria:
The above information were not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site 2500041 | Aix-en-Provence | 13100 | France | |||
| Investigational Site 2500002 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40379431 | Derived | Munro APS, Drysdale SB, Cathie K, Flamein F, Knuf M, Collins AM, Hill HC, Kaiser F, Cohen R, Pinquier D, Vassilouthis NC, Carreno M, Moreau C, Bourron P, Marcelon L, Mari K, Roberts M, Tissieres P, Royal S, Faust SN; HARMONIE Study Group. 180-day efficacy of nirsevimab against hospitalisation for respiratory syncytial virus lower respiratory tract infections in infants (HARMONIE): a randomised, controlled, phase 3b trial. Lancet Child Adolesc Health. 2025 Jun;9(6):404-412. doi: 10.1016/S2352-4642(25)00102-6. | |
| 38157500 |
| Label | URL |
|---|---|
| VAS00006 Plain Language Results Summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Total 8057 participants were enrolled and randomized in 1:1 ratio to nirsevimab or no intervention group between 08 August 2022 to 28 February 2023. Participants were followed up for safety for 12-months (366 days) (for France, Germany, and UK non-reconsented participants) and for 24 months (731 days) (for UK participants who consented to take part into study extension [UK reconsented participants]). As pre-specified in protocol and SAP, results are presented by treatment group.
The study was conducted at 235 investigational sites in France, Germany and the United Kingdom (UK).
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| ID | Title | Description |
|---|---|---|
| FG000 | Nirsevimab | Participants received nirsevimab 50 milligrams (mg) (if weight <5 kilograms [kg]) or 100 mg (if weight ≥5 kg) as a single intramuscular (IM) injection on Day 1. |
| FG001 | No Intervention |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 5, 2024 | Mar 25, 2025 |
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1 in-person randomization visit, with monthly safety and efficacy follow-up conducted through electronic contact through the first 6 months post-dosing/randomization.
The study also included a 12-month (D366) follow-up telephone call. The D366 follow-up telephone call was the final follow-up telephone call for France, Germany and UK non-reconsented participants. The study included an 18-month (D546) and a 24-month (D731, final telephone call) follow-up telephone call for UK reconsented participants.
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| From dosing/randomization (Day 1) up to approximately 7 months |
| Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization Through the Respiratory Syncytial Virus Season in Each Country | 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. | From dosing/randomization (Day 1) up to approximately 7 months |
| Number of Participants With Hospitalization for All-Cause Lower Respiratory Tract Infection Through the Respiratory Syncytial Virus Season | 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. | From dosing/randomization (Day 1) up to approximately 7 months |
| Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization Through 151 Days Post-dosing/Randomization | 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. | From dosing/randomization (Day 1) to Day 151 |
| Number of Participants With Very Severe Respiratory Syncytial Virus Lower Respiratory Tract Infection Through 151 Days Post-dosing/Randomization | 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. | From dosing/randomization (Day 1) to Day 151 |
| Number of Participants With Hospitalization for All-Cause Lower Respiratory Tract Infection Through 151 Days Post-dosing/Randomization | 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. | From dosing/randomization (Day 1) to Day 151 |
| Number of Participants With Immediate Treatment-Emergent Adverse Events (TEAEs) | 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. | Up to 30 minutes post-dosing/randomization on Day 1 |
| Number of Participants With Non-Serious Treatment-Emergent Adverse Events | 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. | From dosing/randomization (Day 1) to Day 31 |
| 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) | 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. | From dosing/randomization (Day 1) to Day 366 |
| Number of Participants With Treatment-Related Serious Adverse Event (for United Kingdom Reconsented Participants) | 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 is missing or not before the treatment period. 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. A treatment-related TEAE was a TEAE considered by the investigator as related or with unknown/missing relationship to treatment for participants who received nirsevimab on Day 1. | From Day 366 to Day 731 |
| Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization Through 181 Days Post-dosing/Randomization | 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 181 days post-dosing/randomization in France, UK, Germany, and overall is presented. | From dosing/randomization (Day 1) to Day 181 |
| Number of Participants With Hospitalization for All-Cause Lower Respiratory Tract Infection Through 181 Days Post-dosing/Randomization | 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 181 days post-dosing/randomization in France, UK, Germany, and overall is presented. | From dosing/randomization (Day 1) to Day 181 |
| Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization From Days 181 to 366 Post-dosing/Randomization | 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 from Days 181 to 366 post-dosing/randomization (with no RSV LRTI hospitalizations before Day 181) in France, UK, Germany, and overall is presented. | From Day 181 to Day 366 |
| Number of Participants With Hospitalization for All-Cause Lower Respiratory Tract Infection From Days 181 to 366 Post-dosing/Randomization | 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 from Days 181 to 366 post-dosing/randomization (with no hospitalizations for all-cause LRTI before Day 181) is presented. | From Day 181 to Day 366 |
| 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) | 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 from Days 366 to 731 post-dosing/randomization (with no RSV LRTI hospitalizations before Day 366) in UK reconsented participants is presented. | From Day 366 to Day 731 |
| 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) | 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 from Days 366 to 731 post-dosing/randomization (with no hospitalizations for all-cause LRTI before Day 366) in UK reconsented participants is presented. | From Day 366 to Day 731 |
| Number of Participants With Recurrent Wheeze (for United Kingdom Reconsented Participants) | Wheeze was defined as a physician-diagnosed wheeze or asthma or related ear, nose and throat (ENT)/respiratory symptoms at an office visit or an illness for which the child was prescribed medication to treat an ENT/respiratory condition. Recurrent wheeze event was defined as 2 or more protocol-defined wheeze episodes throughout follow-up period. | From dosing/randomization (Day 1) to Day 731 |
| Amiens |
| 80054 |
| France |
| Investigational Site Number: 2500014 | Bordeaux | 33076 | France |
| Investigational Site 2500007 | Brest | 29200 | France |
| Investigational Site Number: 2500038 | Brest | 29200 | France |
| Investigational Site Number: 2500045 | Brest | 29200 | France |
| Investigational Site Number: 2500019 | Bron | 69677 | France |
| Investigational Site Number: 2500043 | Brumath | 67170 | France |
| Investigational Site Number: 2500001 | Caen | 14033 | France |
| Investigational Site Number: 2500032 | Chambéry | 73000 | France |
| Investigational Site Number: 2500057 | Clamart | 92140 | France |
| Investigational Site Number: 2500065 | Clamart | 92140 | France |
| Investigational Site Number: 2500029 | Combs-la-Ville | 77380 | France |
| Investigational Site Number: 2500013 | Corbeil-Essonnes | 91100 | France |
| Investigational Site Number: 2500054 | Creil | 60100 | France |
| Investigational Site Number: 2500006 | Créteil | 94010 | France |
| Investigational Site Number: 2500039 | Créteil | 94010 | France |
| Investigational Site Number: 2500023 | Dijon | 21000 | France |
| Investigational Site Number: 2500069 | Draguignan | 83300 | France |
| Investigational Site 2500008 | Essey-lès-Nancy | 54270 | France |
| Investigational Site 2500030 | Étampes | 91150 | France |
| Investigational Site Number: 2500058 | Frouard | 54390 | France |
| Investigational Site Number: 2500064 | Grasse | 06135 | France |
| Investigational Site Number: 2500004 | Grenoble | 38043 | France |
| Investigational Site Number: 2500027 | Héry-sur-Alby | 74540 | France |
| Investigational Site Number: 2500060 | Huningue | 68330 | France |
| Investigational Site 2500059 | La Garenne-Colombes | 92250 | France |
| Investigational Site Number: 2500071 | La Teste-de-Buch | 33260 | France |
| Investigational Site Number: 2500034 | Le Kremlin-Bicêtre | 94270 | France |
| Investigational Site Number: 2500072 | Libourne | 33500 | France |
| Investigational Site 2500046 | Lille | 59000 | France |
| Investigational Site 2500005 | Lille | 59037 | France |
| Investigational Site Number: 2500012 | Limoges | 87042 | France |
| Investigational Site Number: 2500037 | Longjumeau | 91160 | France |
| Investigational Site 2500021 | Maromme | 76150 | France |
| Investigational Site Number: 2500003 | Marseille | 13015 | France |
| Investigational Site Number: 2500073 | Marseille | 13385 | France |
| Investigational Site Number: 2500068 | Mont-de-Marsan | 40000 | France |
| Investigational Site Number: 2500066 | Mont-Saint-Aignan | 76130 | France |
| Investigational Site Number: 2500067 | Montpellier | 34295 | France |
| Investigational Site Number: 2500077 | Morlaix | 29600 | France |
| Investigational Site Number: 2500047 | Nantes | 44093 | France |
| Investigational Site Number: 2500055 | Nice | 06200 | France |
| Investigational Site Number: 2500009 | Nice | 06300 | France |
| Investigational Site Number: 2500040 | Nogent-sur-Marne | 94130 | France |
| Investigational Site Number: 2500022 | Orléans | 45000 | France |
| Investigational Site Number: 2500050 | Orléans | 45067 | France |
| Investigational Site Number: 2500024 | Paris | 75011 | France |
| Investigational Site Number: 2500010 | Paris | 75012 | France |
| Investigational Site Number: 2500075 | Paris | 75012 | France |
| Investigational Site Number: 2500051 | Paris | 75016 | France |
| Investigational Site Number: | Pau | 64000 | France |
| Investigational Site Number: 2500018 | Poissy | 78300 | France |
| Investigational Site Number: 2500026 | Puteaux | 92800 | France |
| Investigational Site Number: 2500042 | Rouen | 76000 | France |
| Investigational Site Number: 2500078 | Saint-Doulchard | 18230 | France |
| Investigational Site Number: 2500074 | Saint-Julien-en-Genevois | 74160 | France |
| Investigational Site Number: 2500044 | Saint-Maur-des-Fossés | 94100 | France |
| Investigational Site 2500020 | Saint-Sébastien-sur-Loire | 44230 | France |
| Investigational Site Number: 2500052 | Saverne | 67700 | France |
| Investigational Site Number: 2500015 | Toulouse | 31059 | France |
| Investigational Site Number: 2500035 | Tours | 37000 | France |
| Investigational Site Number: 2500049 | Vendenheim | 67550 | France |
| Investigational Site Number: 2500011 | Villeneuve-lès-Avignon | 30400 | France |
| Investigational Site Number: 2500063 | Villeneuve-Saint-Georges | 94195 | France |
| Investigational Site 2500028 | Vincennes | 94300 | France |
| Investigational Site Number: 2760036 | Augsburg | 86154 | Germany |
| Investigational Site Number: 2760017 | Bad Wildungen | 34537 | Germany |
| Investigational Site Number: 2760099 | Berlin | 10551 | Germany |
| Investigational Site Number: 2760076 | Berlin | 13353 | Germany |
| Investigational Site Number: 2760056 | Berlin | 13589 | Germany |
| Investigational Site Number: 2760050 | Bielefeld | 33617 | Germany |
| Investigational Site Number: 2760064 | Bocholt | 46397 | Germany |
| Investigational Site Number: 2760098 | Bochum | 44791 | Germany |
| Investigational Site Number: 2760040 | Bonn | 53127 | Germany |
| Investigational Site Number: 2760025 | Bramsche | 49565 | Germany |
| Investigational Site Number: 2760018 | Braunschweig | 38118 | Germany |
| Investigational Site Number: 2760051 | Detmold | 32756 | Germany |
| Investigational Site Number: 2760085 | Dortmund | 44137 | Germany |
| Investigational Site Number: 2760059 | Düsseldorf | 40217 | Germany |
| Investigational Site Number: 2760101 | Düsseldorf | 40589 | Germany |
| Investigational Site Number: 2760081 | Eckental | 90542 | Germany |
| Investigational Site Number: 2760045 | Erfurt | 99086 | Germany |
| Investigational Site Number: 2760047 | Forchheim | 91301 | Germany |
| Investigational Site Number: 2760030 | Frankfurt (Oder) | 15236 | Germany |
| Investigational Site Number: 2760015 | Freiburg I. Breisgau | 79106 | Germany |
| Investigational Site Number: 2760079 | Gera | 07548 | Germany |
| Investigational Site Number: 2760005 | Gilching | 82205 | Germany |
| Investigational Site Number: 2760016 | Göttingen | 37075 | Germany |
| Investigational Site Number: 2760060 | Göttingen | 37075 | Germany |
| Investigational Site Number: 2760033 | Hamburg | 20251 | Germany |
| Investigational Site Number: 2760057 | Hamburg | 20357 | Germany |
| Investigational Site Number: 2760096 | Hamburg | 22415 | Germany |
| Investigational Site Number: 2760032 | Hamm | 59063 | Germany |
| Investigational Site Number: 2760007 | Hanover | 30625 | Germany |
| Investigational Site Number: 2760049 | Heidelberg | 69120 | Germany |
| Investigational Site Number: 2760008 | Herford | 32049 | Germany |
| Investigational Site 2760010 | Hürth | 50354 | Germany |
| Investigational Site Number: 2760091 | Hürth | 50354 | Germany |
| Investigational Site Number: 2760035 | Itzehoe | 25524 | Germany |
| Investigational Site Number: 2760095 | Kassel | 34119 | Germany |
| Investigational Site Number: 2760084 | Kirchen | 57548 | Germany |
| Investigational Site Number: 2760065 | Krefeld | 47799 | Germany |
| Investigational Site Number: 2760020 | Leipzig | 04179 | Germany |
| Investigational Site Number: 2760013 | Leipzig | 4103 | Germany |
| Investigational Site 2760006 | Mainz | 55116 | Germany |
| Investigational Site Number: 2760086 | Mainz | 55131 | Germany |
| Investigational Site Number: 2760014 | Mannheim | 68161 | Germany |
| Investigational Site Number: 2760023 | Mönchengladbach | 41236 | Germany |
| Investigational Site Number: 2760054 | Mönchengladbach | 41236 | Germany |
| Investigational Site Number: 2760094 | München | 80638 | Germany |
| Investigational Site Number: 2760034 | München | 81369 | Germany |
| Investigational Site Number: 2760038 | München | 81369 | Germany |
| Investigational Site Number: 2760019 | München | 81375 | Germany |
| Investigational Site Number: 2760046 | München | 81377 | Germany |
| Investigational Site Number: 2760061 | München | 81925 | Germany |
| Investigational Site Number: 2760083 | Münster | 48149 | Germany |
| Investigational Site Number: 2760027 | Neuss | 41469 | Germany |
| Investigational Site Number: 2760004 | Niedernhausen | 65527 | Germany |
| Investigational Site Number: 2760071 | Passau | 94032 | Germany |
| Investigational Site Number: 2760001 | Regensburg | 93053 | Germany |
| Investigational Site Number: 2760003 | Rosenheim | 83026 | Germany |
| Investigational Site Number: 2760062 | Rüsselsheim A. Main | 65428 | Germany |
| Investigational Site Number: 2760092 | Saarbrücken | 66119 | Germany |
| Investigational Site 2760029 | Schönau | 83471 | Germany |
| Investigational Site Number: 2760044 | Schweigen | 76889 | Germany |
| Investigational Site Number: 2760069 | Suhl | 98527 | Germany |
| Investigational Site Number: 2760067 | Tuttlingen | 78532 | Germany |
| Investigational Site Number: 2760043 | Weiden | 92637 | Germany |
| Investigational Site Number: 2760002 | Wesel | 46483 | Germany |
| Investigational Site Number: 2760093 | Wolfsburg | 38440 | Germany |
| Investigational Site Number: 2760028 | Wolfsburg | 38448 | Germany |
| Investigational Site Number: 8260007 | Amersham | HP7 0JD | United Kingdom |
| Investigational Site Number: 8260096 | Ashford | N24 0LZ | United Kingdom |
| Investigational Site Number: 8260053 | Banbury | OX16 9AD | United Kingdom |
| Investigational Site Number: 8260057 | Barnet | EN5 3DJ | United Kingdom |
| Investigational Site Number: 8260004 | Barnsley | S75 2EP | United Kingdom |
| Investigational Site Number: 8260107 | Basildon | SS16 5NL | United Kingdom |
| Investigational Site Number: 8260110 | Basingstoke | RG24 9NA | United Kingdom |
| Investigational Site Number: 8260067 | Bath | BA1 3NG | United Kingdom |
| Investigational Site 8260009 | Bath | BA2 3HT | United Kingdom |
| Investigational Site Number: 8260100 | Bebington | CH63 9JP | United Kingdom |
| Investigational Site Number: 8260073 | Belfast | BT7 2EB | United Kingdom |
| Investigational Site Number: 8260095 | Bicester | OX26 6HR | United Kingdom |
| Investigational Site Number: 8260029 | Blackburn | BB2 3HH | United Kingdom |
| Investigational Site Number: 8260108 | Bollington | SK10 5JH | United Kingdom |
| Investigational Site Number: 8260085 | Bolton | BL2 6NT | United Kingdom |
| Investigational Site Number: 8260013 | Bradford | BD9 6RJ | United Kingdom |
| Investigational Site Number: 8260112 | Brierley Hill | DY5 1RU | United Kingdom |
| Investigational Site Number: 8260058 | Brighton | BN2 5BE | United Kingdom |
| Investigational Site Number: 8260008 | Bristol | BS2 8EX | United Kingdom |
| Investigational Site Number: 8260019 | Bristol | BS34 6BQ | United Kingdom |
| Investigational Site 8260046 | Bristol | BS37 4AX | United Kingdom |
| Investigational Site Number: 8260063 | Bury St Edmunds | IP33 2QZ | United Kingdom |
| Investigational Site Number: 8260040 | Cardiff | CF14 4XN | United Kingdom |
| Investigational Site Number: 8260062 | Cheltenham | GL53 7AN | United Kingdom |
| Investigational Site Number: 8260066 | Chertsey | KT16 0PZ | United Kingdom |
| Investigational Site Number: 8260061 | Chippenham | SN16 1GG | United Kingdom |
| Investigational Site Number: 8260036 | Corby | NN17 2UR | United Kingdom |
| Investigational Site Number: 8260054 | Cottingham | HU16 5JQ | United Kingdom |
| Investigational Site Number: 8260035 | Darlington | DL3 6HX | United Kingdom |
| Investigational Site Number: 8260037 | Darlington | DL3 6HX | United Kingdom |
| Investigational Site Number: 8260041 | Darlington | DL3 8SQ | United Kingdom |
| Investigational Site 8260064 | Dorchester | DT1 2JY | United Kingdom |
| Investigational Site Number: 8260087 | Dundee | DD1 9SY | United Kingdom |
| Investigational Site 8260018 | Exeter | EX2 5DW | United Kingdom |
| Investigational Site Number: 8260020 | Gillingham | ME7 5NY | United Kingdom |
| Investigational Site Number: 8260056 | Great Yarmouth | NR31 6LA | United Kingdom |
| Investigational Site Number: 8260069 | Harrow | HA1 3UJ | United Kingdom |
| Investigational Site Number: 8260109 | Highcliffe | BH23 5ET | United Kingdom |
| Investigational Site Number: 8260101 | Ipswich | IP4 5PD | United Kingdom |
| Investigational Site Number: 8260027 | Leicester | E1 5WW | United Kingdom |
| Investigational Site Number: 8260091 | Leicester | LE1 6NB | United Kingdom |
| Investigational Site Number: 8260074 | Leicester | LE9 7RT | United Kingdom |
| Investigational Site Number: 8260088 | Liskeard | PL14 3XA | United Kingdom |
| Investigational Site Number: 8260030 | Liverpool | L12 2AP | United Kingdom |
| Investigational Site Number: 8260092 | Liverpool | L5 8XR | United Kingdom |
| Investigational Site Number: 8260010 | London | E1 1BB | United Kingdom |
| Investigational Site Number: 8260039 | London | E9 6SR | United Kingdom |
| Investigational Site Number: 8260075 | London | NW1 2PG | United Kingdom |
| Investigational Site Number: 8260011 | London | NW3 2QG | United Kingdom |
| Investigational Site Number: 8260076 | London | NW3 2QU | United Kingdom |
| Investigational Site Number: 8260077 | London | NW5 1TR | United Kingdom |
| Investigational Site Number: 8260084 | London | SE1 7EH | United Kingdom |
| Investigational Site Number: 8260079 | London | SE5 9RS | United Kingdom |
| Investigational Site Number: 8260078 | London | SW10 9NH | United Kingdom |
| Investigational Site Number: 8260001 | London | SW17 0RE | United Kingdom |
| Investigational Site Number: 8260002 | London | W2 1NY | United Kingdom |
| Investigational Site Number: 8260071 | Macclesfield | SK10 3BL | United Kingdom |
| Investigational Site Number: 8260015 | Manchester | M13 9WL | United Kingdom |
| Investigational Site Number: 8260097 | Margate | CT9 4AN | United Kingdom |
| Investigational Site Number: 8260012 | Middlesbrough | TS4 3BW | United Kingdom |
| Investigational Site Number: 8260042 | Milton Keynes | MK6 5LD | United Kingdom |
| Investigational Site Number: 8260072 | Nantwich | CW5 5NX | United Kingdom |
| Investigational Site Number: 8260044 | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| Investigational Site Number: 8260119 | Newport | PO30 5TG | United Kingdom |
| Investigational Site Number: 8260045 | Newquay | TR7 1RU | United Kingdom |
| Investigational Site Number: 8260024 | Norwich | NR4 7UY | United Kingdom |
| Investigational Site 8260028 | Nottingham | NG7 2QW | United Kingdom |
| Investigational Site 8260043 | Nottingham | NG9 6DX | United Kingdom |
| Investigational Site Number: 8260022 | Oxford | OX3 9DU | United Kingdom |
| Investigational Site Number: 8260003 | Oxford | OX4 1XB | United Kingdom |
| Investigational Site Number: 8260080 | Penzance | TR18 3DX | United Kingdom |
| Investigational Site Number: 8260093 | Peterborough | PE3 9GZ | United Kingdom |
| Investigational Site Number: 8260081 | Plymouth | PL6 8DH | United Kingdom |
| Investigational Site Number: 8260094 | Poole | BH15 2JB | United Kingdom |
| Investigational Site 8260005 | Poole | BH16 5PW | United Kingdom |
| Investigational Site Number: 8260065 | Portsmouth | PO6 3LY | United Kingdom |
| Investigational Site Number: 8260106 | Prescot | L35 5DR | United Kingdom |
| Investigational Site Number: 8260117 | Preston | PR2 9HT | United Kingdom |
| Investigational Site Number: 8260016 | Reading | RG1 5AN | United Kingdom |
| Investigational Site Number: 8260086 | Reading | RG8 7DP | United Kingdom |
| Investigational Site Number: 8260103 | Redhill | RH1 5RH | United Kingdom |
| Investigational Site Number: 8260105 | Redruth | TR15 3DU | United Kingdom |
| Investigational Site 8260026 | Romsey | SO51 8EN | United Kingdom |
| Investigational Site Number: 8260068 | Runcorn | WA7 2DA | United Kingdom |
| Investigational Site Number: 8260059 | Salford | M6 8HD | United Kingdom |
| Investigational Site Number: 8260111 | Salisbury | SP2 8BJ | United Kingdom |
| Investigational Site Number: 8260014 | Sheffield | S10 2TH | United Kingdom |
| Investigational Site 8260051 | Southampton | SO16 6YD | United Kingdom |
| Investigational Site Number: 8260038 | Stevenage | SG1 4AB | United Kingdom |
| Investigational Site Number: 8260034 | Stockport | SK2 7JE | United Kingdom |
| Investigational Site Number: 8260025 | Stockton-on-Tees | TS19 8PE | United Kingdom |
| Investigational Site Number: 8260052 | Sunderland | SR4 7TP | United Kingdom |
| Investigational Site Number: 8260098 | Sutton in Ashfield | NG17 4JL | United Kingdom |
| Investigational Site Number: 8260083 | Swanage | BH19 1HB | United Kingdom |
| Investigational Site Number: 8260047 | Swindon | SN3 6BB | United Kingdom |
| Investigational Site Number: 8260115 | Swinton | M27 0FX | United Kingdom |
| Investigational Site Number: 8260102 | Tameside | OL6 9RW | United Kingdom |
| Investigational Site Number: 8260032 | Taunton | TA1 5DA | United Kingdom |
| Investigational Site Number: 8260031 | Torpoint | PL11 2TB | United Kingdom |
| Investigational Site 8260082 | Wantage | OX12 9BN | United Kingdom |
| Investigational Site Number: 8260017 | Waterlooville | PO8 8DL | United Kingdom |
| Investigational Site Number: 8260104 | Winchester | SO22 5DG | United Kingdom |
| Investigational Site Number: 8260021 | Winscombe | BS25 1AF | United Kingdom |
| Investigational Site Number: 8260006 | Witney | OX28 6JS | United Kingdom |
| Investigational Site Number: 8260060 | Witney | OX29 4QB | United Kingdom |
| Investigational Site Number: 8260050 | Yeovil | BA21 4AT | United Kingdom |
| Investigational Site Number: 8260116 | York | YO24 1LW | United Kingdom |
| Investigational Site 8260023 | York | YO31 8HE | United Kingdom |
| Derived |
| Drysdale SB, Cathie K, Flamein F, Knuf M, Collins AM, Hill HC, Kaiser F, Cohen R, Pinquier D, Felter CT, Vassilouthis NC, Jin J, Bangert M, Mari K, Nteene R, Wague S, Roberts M, Tissieres P, Royal S, Faust SN; HARMONIE Study Group. Nirsevimab for Prevention of Hospitalizations Due to RSV in Infants. N Engl J Med. 2023 Dec 28;389(26):2425-2435. doi: 10.1056/NEJMoa2309189. |
Participants received no respiratory syncytial virus (RSV) preventive intervention on Day 1.
| Randomized and Treated | 1 participant of the no intervention group wrongly received the study intervention. |
|
| Participants Entered Study Extension | UK participants who consented to take part into 12-month study extension. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The All Randomized Set consisted of all participants randomly assigned to either the nirsevimab group or the no intervention group.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Nirsevimab | Participants received nirsevimab 50 mg (if weight <5 kg) or 100 mg (if weight ≥5 kg) as a single IM injection on Day 1. |
| BG001 | No Intervention | Participants received no RSV preventive intervention on Day 1. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | months |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI) Hospitalization Through the Respiratory Syncytial Virus Season | 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. | The All Randomized Set consisted of all participants randomly assigned to either the nirsevimab group or the no intervention group. | Posted | Count of Participants | Participants | From dosing/randomization (Day 1) up to approximately 7 months |
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| Secondary | Number of Participants With Very Severe Respiratory Syncytial Virus Lower Respiratory Tract Infection Through the Respiratory Syncytial Virus Season | 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. | The All Randomized Set consisted of all participants randomly assigned to either the nirsevimab group or the no intervention group. | Posted | Count of Participants | Participants | From dosing/randomization (Day 1) up to approximately 7 months |
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| Secondary | Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization Through the Respiratory Syncytial Virus Season in Each Country | 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. | 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. | Posted | Count of Participants | Participants | From dosing/randomization (Day 1) up to approximately 7 months |
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| Secondary | Number of Participants With Hospitalization for All-Cause Lower Respiratory Tract Infection Through the Respiratory Syncytial Virus Season | 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. | 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. | Posted | Count of Participants | Participants | From dosing/randomization (Day 1) up to approximately 7 months |
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| Secondary | Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization Through 151 Days Post-dosing/Randomization | 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. | 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. | Posted | Count of Participants | Participants | From dosing/randomization (Day 1) to Day 151 |
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| Secondary | Number of Participants With Very Severe Respiratory Syncytial Virus Lower Respiratory Tract Infection Through 151 Days Post-dosing/Randomization | 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. | 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. | Posted | Count of Participants | Participants | From dosing/randomization (Day 1) to Day 151 |
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| Secondary | Number of Participants With Hospitalization for All-Cause Lower Respiratory Tract Infection Through 151 Days Post-dosing/Randomization | 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. | 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. | Posted | Count of Participants | Participants | From dosing/randomization (Day 1) to Day 151 |
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| Secondary | Number of Participants With Immediate Treatment-Emergent Adverse Events (TEAEs) | 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. | 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. | Posted | Count of Participants | Participants | Up to 30 minutes post-dosing/randomization on Day 1 |
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| Secondary | Number of Participants With Non-Serious Treatment-Emergent Adverse Events | 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. | 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. | Posted | Count of Participants | Participants | From dosing/randomization (Day 1) to Day 31 |
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| 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) | 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. | 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. | Posted | Count of Participants | Participants | From dosing/randomization (Day 1) to Day 366 |
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| Secondary | Number of Participants With Treatment-Related Serious Adverse Event (for United Kingdom Reconsented Participants) | 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 is missing or not before the treatment period. 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. A treatment-related TEAE was a TEAE considered by the investigator as related or with unknown/missing relationship to treatment for participants who received nirsevimab on Day 1. | 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. | Posted | Count of Participants | Participants | From Day 366 to Day 731 |
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| Secondary | Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization Through 181 Days Post-dosing/Randomization | 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 181 days post-dosing/randomization in France, UK, Germany, and overall is presented. | 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. | Posted | Count of Participants | Participants | From dosing/randomization (Day 1) to Day 181 |
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| Secondary | Number of Participants With Hospitalization for All-Cause Lower Respiratory Tract Infection Through 181 Days Post-dosing/Randomization | 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 181 days post-dosing/randomization in France, UK, Germany, and overall is presented. | 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. | Posted | Count of Participants | Participants | From dosing/randomization (Day 1) to Day 181 |
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| Secondary | Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization From Days 181 to 366 Post-dosing/Randomization | 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 from Days 181 to 366 post-dosing/randomization (with no RSV LRTI hospitalizations before Day 181) in France, UK, Germany, and overall is presented. | 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. | Posted | Count of Participants | Participants | From Day 181 to Day 366 |
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| Secondary | Number of Participants With Hospitalization for All-Cause Lower Respiratory Tract Infection From Days 181 to 366 Post-dosing/Randomization | 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 from Days 181 to 366 post-dosing/randomization (with no hospitalizations for all-cause LRTI before Day 181) is presented. | 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. | Posted | Count of Participants | Participants | From Day 181 to Day 366 |
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| 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) | 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 from Days 366 to 731 post-dosing/randomization (with no RSV LRTI hospitalizations before Day 366) in UK reconsented participants is presented. | 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. | Posted | Count of Participants | Participants | From Day 366 to Day 731 |
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| 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) | 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 from Days 366 to 731 post-dosing/randomization (with no hospitalizations for all-cause LRTI before Day 366) in UK reconsented participants is presented. | 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. | Posted | Count of Participants | Participants | From Day 366 to Day 731 |
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| Secondary | Number of Participants With Recurrent Wheeze (for United Kingdom Reconsented Participants) | Wheeze was defined as a physician-diagnosed wheeze or asthma or related ear, nose and throat (ENT)/respiratory symptoms at an office visit or an illness for which the child was prescribed medication to treat an ENT/respiratory condition. Recurrent wheeze event was defined as 2 or more protocol-defined wheeze episodes throughout follow-up period. | 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. | Posted | Count of Participants | Participants | From dosing/randomization (Day 1) to Day 731 |
|
|
SAEs and all-cause mortality were collected from dosing/randomization (Day 1) up to end of follow-up (Day 366 for France, Germany, UK non-reconsented participants and Day 731 for UK reconsented participants). Non-serious AEs were collected from dosing/randomization (Day 1) up to Day 31 as pre-specified in protocol.
Analysis was performed on the SafAS. As pre-specified in the protocol and SAP, results are presented by treatment group. Safety analysis was not planned exclusively for UK reconsented participants, and no separate safety data was collected for this subgroup.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nirsevimab | Participants received nirsevimab 50 mg (if weight <5 kg) or 100 mg (if weight ≥5 kg) as a single IM injection on Day 1. | 1 | 4,016 | 262 | 4,016 | 324 | 4,016 |
| EG001 | No Intervention | Participants received no RSV preventive intervention on Day 1. | 0 | 4,018 | 222 | 4,018 | 279 | 4,018 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Accidental Exposure To Product | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
| |
| Clavicle Fracture | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
| |
| Forearm Fracture | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
| |
| Foreign Body In Gastrointestinal Tract | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
| |
| Foreign Body Ingestion | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
| |
| Hand Fracture | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
| |
| Head Injury | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
| |
| Hip Fracture | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
| |
| Lower Limb Fracture | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
| |
| Poisoning | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
| |
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
| |
| Skull Fracture | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
| |
| Stoma Prolapse | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
| |
| Thermal Burn | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
| |
| Toxicity To Various Agents | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
| |
| Traumatic Haematoma | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
| |
| Upper Limb Fracture | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
| |
| Coronavirus Test Positive | Investigations | MedDra 25.0 | Systematic Assessment |
| |
| Human Rhinovirus Test Positive | Investigations | MedDra 25.0 | Systematic Assessment |
| |
| Oxygen Saturation Decreased | Investigations | MedDra 25.0 | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDra 25.0 | Systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDra 25.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDra 25.0 | Systematic Assessment |
| |
| Arteriovenous Malformation | Congenital, familial and genetic disorders | MedDra 25.0 | Systematic Assessment |
| |
| Atrial Septal Defect | Congenital, familial and genetic disorders | MedDra 25.0 | Systematic Assessment |
| |
| Bicuspid Aortic Valve | Congenital, familial and genetic disorders | MedDra 25.0 | Systematic Assessment |
| |
| Birth Mark | Congenital, familial and genetic disorders | MedDra 25.0 | Systematic Assessment |
| |
| Cataract Congenital | Congenital, familial and genetic disorders | MedDra 25.0 | Systematic Assessment |
| |
| Choanal Stenosis | Congenital, familial and genetic disorders | MedDra 25.0 | Systematic Assessment |
| |
| Cleft Palate | Congenital, familial and genetic disorders | MedDra 25.0 | Systematic Assessment |
| |
| Coarctation Of The Aorta | Congenital, familial and genetic disorders | MedDra 25.0 | Systematic Assessment |
| |
| Congenital Megacolon | Congenital, familial and genetic disorders | MedDra 25.0 | Systematic Assessment |
| |
| Craniofacial Deformity | Congenital, familial and genetic disorders | MedDra 25.0 | Systematic Assessment |
| |
| Factor Viii Deficiency | Congenital, familial and genetic disorders | MedDra 25.0 | Systematic Assessment |
| |
| Hydrocele | Congenital, familial and genetic disorders | MedDra 25.0 | Systematic Assessment |
| |
| Hypospadias | Congenital, familial and genetic disorders | MedDra 25.0 | Systematic Assessment |
| |
| Kabuki Make-Up Syndrome | Congenital, familial and genetic disorders | MedDra 25.0 | Systematic Assessment |
| |
| Laryngomalacia | Congenital, familial and genetic disorders | MedDra 25.0 | Systematic Assessment |
| |
| Pulmonary Sequestration | Congenital, familial and genetic disorders | MedDra 25.0 | Systematic Assessment |
| |
| Pyloric Stenosis | Congenital, familial and genetic disorders | MedDra 25.0 | Systematic Assessment |
| |
| Urethral Valves | Congenital, familial and genetic disorders | MedDra 25.0 | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Hypersplenism | Blood and lymphatic system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Immune Thrombocytopenia | Blood and lymphatic system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Altered State Of Consciousness | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Febrile Convulsion | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Fontanelle Bulging | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Hypertonia | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Infantile Spasms | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Loss Of Consciousness | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Partial Seizures | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Petit Mal Epilepsy | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Seizure Like Phenomena | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Status Epilepticus | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Tonic Convulsion | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Unresponsive To Stimuli | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Eye Disorder | Eye disorders | MedDra 25.0 | Systematic Assessment |
| |
| Eye Movement Disorder | Eye disorders | MedDra 25.0 | Systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDra 25.0 | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDra 25.0 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Cyclic Vomiting Syndrome | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Diaphragmatic Hernia | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Diarrhoea Haemorrhagic | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Gastrointestinal Disorder | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Incarcerated Inguinal Hernia | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Inguinal Hernia | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Inguinal Hernia, Obstructive | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Intestinal Perforation | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Intussusception | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Protein-Losing Gastroenteropathy | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Renal Impairment | Renal and urinary disorders | MedDra 25.0 | Systematic Assessment |
| |
| Acne Infantile | Skin and subcutaneous tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Dermatitis Allergic | Skin and subcutaneous tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Erythema Multiforme | Skin and subcutaneous tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Musculoskeletal Discomfort | Musculoskeletal and connective tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Adrenal Insufficiency | Endocrine disorders | MedDra 25.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDra 25.0 | Systematic Assessment |
| |
| Failure To Thrive | Metabolism and nutrition disorders | MedDra 25.0 | Systematic Assessment |
| |
| Feeding Disorder | Metabolism and nutrition disorders | MedDra 25.0 | Systematic Assessment |
| |
| Food Refusal | Metabolism and nutrition disorders | MedDra 25.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDra 25.0 | Systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDra 25.0 | Systematic Assessment |
| |
| Type 1 Diabetes Mellitus | Metabolism and nutrition disorders | MedDra 25.0 | Systematic Assessment |
| |
| Weight Gain Poor | Metabolism and nutrition disorders | MedDra 25.0 | Systematic Assessment |
| |
| Abscess Neck | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Adenovirus Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Bacterial Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Beta Haemolytic Streptococcal Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Bullous Impetigo | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Cellulitis Orbital | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Conjunctivitis Bacterial | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Coronavirus Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Croup Infectious | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Cytomegalovirus Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Dermatitis Infected | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Dermo-Hypodermitis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Ear Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Ear Infection Viral | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Eczema Herpeticum | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Eczema Infected | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Enterovirus Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Escherichia Pyelonephritis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Gastric Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Gastroenteritis Adenovirus | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Gastroenteritis Enteroviral | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Gastroenteritis Norovirus | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Gastroenteritis Rotavirus | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Gastroenteritis Viral | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Gastrointestinal Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Gastrointestinal Viral Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Herpes Simplex | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Infectious Mononucleosis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Intervertebral Discitis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Localised Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Lung Abscess | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Lymph Node Abscess | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Mastoiditis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Meningitis Enteroviral | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Meningitis Neonatal | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Meningitis Viral | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Norovirus Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Oral Candidiasis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Osteomyelitis Bacterial | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Otitis Media | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Otitis Media Acute | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Parainfluenzae Virus Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Periorbital Cellulitis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Pharyngitis Streptococcal | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Pyelonephritis Acute | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Respiratory Syncytial Virus Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Respiratory Tract Infection Viral | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Rhinovirus Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Roseola | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Rotavirus Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Salmonellosis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Staphylococcal Skin Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Streptococcal Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Streptococcal Sepsis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Subglottic Laryngitis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Suspected Covid-19 | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Tonsillitis Bacterial | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Urachal Abscess | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Viral Diarrhoea | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Viral Pharyngitis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Viral Rash | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Viral Rhinitis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Cyanosis | Vascular disorders | MedDra 25.0 | Systematic Assessment |
| |
| Kawasaki's Disease | Vascular disorders | MedDra 25.0 | Systematic Assessment |
| |
| Acute Myelomonocytic Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 25.0 | Systematic Assessment |
| |
| Allergy To Vaccine | Immune system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Alloimmunisation | Immune system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Anaphylactic Reaction | Immune system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Drug Hypersensitivity | Immune system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Food Allergy | Immune system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Milk Allergy | Immune system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Crying | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Electrocution | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Hernia | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Hyperthermia | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Hypothermia | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Breath Holding | Psychiatric disorders | MedDra 25.0 | Systematic Assessment |
| |
| Stereotypy | Psychiatric disorders | MedDra 25.0 | Systematic Assessment |
| |
| Breast Inflammation | Reproductive system and breast disorders | MedDra 25.0 | Systematic Assessment |
| |
| Testicular Torsion | Reproductive system and breast disorders | MedDra 25.0 | Systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Brief Resolved Unexplained Event | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Choking | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Neonatal Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Obstructive Sleep Apnoea Syndrome | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Respiratory Depression | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Respiratory Disorder | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Tonsillar Hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDra 25.0 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDra 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
|
The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi Pasteur | 800-633-1610 | 6# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 14, 2025 | Mar 25, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000709769 | nirsevimab |
Not provided
Not provided
Not provided
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| OG001 | No Intervention | Participants received no RSV preventive intervention on Day 1. |
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| No Intervention |
Participants received no RSV preventive intervention on Day 1. |
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