respiratory syncytial virus (RSV) infection MedDRA version: 21.1 Level: PT Classification code 10061603 Term: Respiratory syncytial virus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Nirsevimab
Product Code: MEDI8897
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: NIRSEVIMAB
CAS Number: 1989556-22-0
Current Sponsor code: 526
Con
Sponsors
Sanofi Pasteur
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Aged 0 to 12 months (calendar age) who are entering their first RSV season on the day of inclusion - Informed consent form has been signed and dated by the parent(s) or other LAR(s) (and by an independent witness if required by local regulations) - Participant and parent/LAR are able to attend the scheduled visit and to comply with all study procedures Are the trial subjects under 18? yes Number of subjects for this age range: 28860 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Participants are not eligible for the study if any of the following criteria are met: - Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) - Active confirmed RSV infection at the time of dosing/randomization - Active LRTI at the time of dosing/randomization - Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study intervention used in the study or to a product containing any of the same substances - Laboratory confirmed thrombocytopenia, or known thrombocytopenia, as reported by the parent/LAR, contraindicating intramuscular injection - Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection - Any condition that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion - Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature = 38.0°C [= 100.4°F]) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided - Mother of the infant participant was administered an RSV vaccine during her pregnancy with the infant participant - Receipt of any monoclonal antibody by the infant participant - Receipt of immune globulins, blood or blood-derived products in the past 3 months by the infant participant - Participation at the time of study enrollment or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure - Eligible to receive palivizumab at time of inclusion (as per local guidelines) - In an emergency setting or hospitalized involuntarily - Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1/ Incidence of very severe RSV LRTI through the RSV season: Number of very severe RSV LRTI through the RSV season. Severe RSV LRTI are defined as confirmed RSV hospitalization for LRTI with an oxygen saturation (SaO2) < 90% (at any time) and oxygen supplementation. 2/ Incidence of hospitalization for LRTI through the RSV season in each country: Number of RSV LRTI hospitalization in each country through the RSV season. 3/ Overall hospitalization for all cause LRTI in all 3 countries combined throughout the RSV season: Number of RSV LRTI hospitalization in all 3 countries combined through the RSV season. 4/ Incidence (overall and in each country) of RSV LRTI hospitalization throughout 150 days post-dosing/randomization: Number of RSV LRTI hospitalization, overall and in each country, throughout 150 days post-dosing/randomization. 5/ Incidence of very severe RSV LRTI in all 3 countries combined through 150 days post-dosing/randomization: Number of very severe RSV LRTI in all 3 countries combined through 151 days post-dosing/randomization. Severe RSV LRTI are defined as confirmed RSV hospitalization for LRTI with an oxygen saturation (SaO2) < 90% (at any time) and oxygen supplementation. ;Timepoint(s) of evaluation of this end point: 1/ to 3/: Up to 180 days post-dosing/randomization 4/, 5/: Day 151 | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To assess the efficacy of nirsevimab in preventing RSV LRTI hospitalization compared to no intervention;Secondary Objective: - To assess the efficacy of nirsevimab in preventing very severe RSV LRTI compared to no intervention - To assess the efficacy of nirsevimab in preventing RSV LRTI hospitalization compared to no intervention in each country - To assess the efficacy of nirsevimab in preventing hospitalizations for all-cause LRTI compared to no intervention - To assess the efficacy of nirsevimab in preventing RSV LRTI hospitalization through 150 days post-dosing/randomization (overall and in each country) - To assess the efficacy of nirsevimab in preventing very severe RSV LRTI through 150 days post-dosing/randomization - To assess the efficacy of nirsevimab in preventing hospitalizations for all-cause LRTI through 150 days post-dosing/randomization - To further characterize the safety profile of nirsevimab ;Primary end point(s): Overall incidence of RSV LRTI hospitalization through the RSV season: Number of RSV LRTI hospitalization through the RSV season. ;Timepoint(s) of evaluation of this end point: Up to 180 days post-dosing/randomization | — |
Countries
France, Germany, United Kingdom
Contacts
Public ContactDirection des Opérations Cliniques
Sanofi-aventis France
Outcome results
None listed