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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
110
Pharmaceutical form:Sterile solution for injection-Route of administration:Intramuscular
Investigational Site Number : 3560002
Bengaluru, India
Investigational Site Number : 3560008
Jaipur, India
Investigational Site Number : 3560003
Kolkata, India
Investigational Site Number : 3560007
Nagpur, India
Presence of immediate adverse events (AEs)
Number of participants experiencing immediate AEs
Time frame: Within 30 minutes after immunization
Presence of non-serious AEs
Number of participants experiencing non-serious AEs
Time frame: From Day 01 through Day 31
Presence of adverse events of special interest (AESIs) throughout the study
Number of participants experiencing AESIs
Time frame: Throughout the study (approximately 6 months)
Presence of medically attended adverse events (MAAEs) throughout the study
Number of participants experiencing MAAEs
Time frame: Throughout the study (approximately 6 months)
Presence of serious adverse events (SAEs) throughout the study
Number of participants experiencing SAEs
Time frame: Throughout the study (approximately 6 months)
Incidence of medically attended lower respiratory tract infection (LRTI) (outpatient and inpatient) due to reverse transcription--polymerase chain reaction (RT-PCR) confirmed RSV
Incidence of medically attended LRTI (outpatient and inpatient) due to reverse transcription--polymerase chain reaction (RT-PCR) confirmed RSV
Time frame: Through 180 days after dosing
Incidence of LRTI hospitalizations due to RT-PCR confirmed RSV through 180 days after dosing
Incidence of LRTI hospitalizations due to RT-PCR confirmed RSV through 180 days after dosing
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Investigational Site Number : 3560001
New Delhi, India
Investigational Site Number : 3560004
Pune, India
Investigational Site Number : 3560006
Vizianagaram, India
Time frame: Through 180 days after dosing