RSV Immunization
Conditions
Brief summary
The purpose of this study is to describe the safety and efficacy outcomes associated with the use of nirsevimab, administered as per routine clinical practice, in neonates and infants aged 0 to 12 months 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.
Detailed description
Study duration: up to 16 months, including 10 months of enrollment and 6 months of follow-up * Treatment duration: 1 day; 1 intramuscular (IM) injection * Visit frequency: * 1 in-person visit for immunization (Visit \[V\] 01) at Day (D) 1. * 3 phone call visits (V2, V3 and V4) at D31 (+ 14 days), D91 (+ 14 days) and D181 (+14 days) respectively.
Interventions
BIOLOGICALNirsevimab
Pharmaceutical form:Sterile solution for injection-Route of administration:Intramuscular
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Months to 24 Months
Healthy volunteers
Yes
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
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply: * 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 * 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 ≥ 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 * 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 Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of immediate adverse events (AEs) | Within 30 minutes after immunization | Number of participants experiencing immediate AEs |
| Presence of non-serious AEs | From Day 01 through Day 31 | Number of participants experiencing non-serious AEs |
| Presence of adverse events of special interest (AESIs) throughout the study | Throughout the study (approximately 6 months) | Number of participants experiencing AESIs |
| Presence of medically attended adverse events (MAAEs) throughout the study | Throughout the study (approximately 6 months) | Number of participants experiencing MAAEs |
| Presence of serious adverse events (SAEs) throughout the study | Throughout the study (approximately 6 months) | Number of participants experiencing SAEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of medically attended lower respiratory tract infection (LRTI) (outpatient and inpatient) due to reverse transcription--polymerase chain reaction (RT-PCR) confirmed RSV | Through 180 days after dosing | Incidence of medically attended LRTI (outpatient and inpatient) due to reverse transcription--polymerase chain reaction (RT-PCR) confirmed RSV |
| Incidence of LRTI hospitalizations due to RT-PCR confirmed RSV through 180 days after dosing | Through 180 days after dosing | Incidence of LRTI hospitalizations due to RT-PCR confirmed RSV through 180 days after dosing |
Countries
India
Outcome results
None listed