None listed
Conditions
Interventions
Intervention1: Nirsevimab: -IM injection for neonates and infants aged 0 to 12 months born or entering their first RSV season (50 mg if weight less than 5 kg
100 mg if weight more than equal to 5 kg)
- 2 IM injections (2x100 mg) for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
Control Interven
Sponsors
Sanofi Healthcare India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: - Neonates and infants aged 0 to 12 months on the day of inclusion and born during or entering their first RSV season OR children up to 24 months of age on the day of inclusion who remain vulnerable to severe RSV disease through their second RSV season. - Informed consent form has been signed and dated by the participant s parent(s) or other legally acceptable representative(s). - Participant and parent(s)/legally acceptable representative(s) are able to attend all scheduled visits and to comply with all study procedures
Exclusion criteria
Exclusion criteria: - 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 substances9 - Known thrombocytopenia, as reported by the parent(s)/legally acceptable representative(s), contraindicating intramuscular injection. - Known bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection - Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion. - Active LRTI on the day of study intervention administration. - Active RSV infection on the day of study intervention administration. - Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature more than equal to 38.0 C [more than equal to 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. - Receipt of palivizumab or other RSV monoclonal antibody or any RSV vaccine in the same RSV season than inclusion in the study. - Mother of the participant was administered an RSV vaccine during her pregnancy with the participant - Receipt of immune globulins, blood or blood-derived products in the past 3 months. - Receipt of any investigational drug in the last 30 days prior to the inclusion in the study. - Participation at the time of study enrollment or in the 4 weeks preceding the study intervention administration or planned participation during the present study period, in another clinical study investigating a vaccine, drug, medical device, or medical procedure. - Being in an emergency setting. - Identified as a natural or adopted child of the investigator or employee with direct involvement in the proposed study. - Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of participant safety or study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To describe the safety outcomes associated with the use of nirsevimab injection in neonates and infants born during or entering their first RSV season and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.Timepoint: 181 days | — |
Secondary
| Measure | Time frame |
|---|---|
| To describe the occurrence of medically attended RSV lower respiratory tract infection (LRTI) in neonates and infants born during or entering their first RSV season and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. To describe the occurrence of RSV LRTI hospitalization in neonates and infants born during or entering their first RSV season and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.Timepoint: 180 days | — |
Countries
India
Contacts
Public ContactLaxman Deshmukh
Sanofi India Limited (SIL)
Outcome results
None listed