The purpose of this study is to evaluate the Safety and Efficacy of Nirsevimab, in Healthy Preterm and Term Infants in China
This is a Phase 3 randomized, double-blind, placebo-controlled, single-dose study to determine if nirsevimab will prevent medically attended RSV-confirmed LRTI in healthy preterm and term infants entering their first RSV season. The population to be enrolled is healthy preterm and term infants \> 29 weeks 0 days GA entering their first RSV season, who would not receive RSV prophylaxis based on the American Academy of Pediatrics (AAP) or other local or national guidelines. Approximately 800 subjects will be randomized 2:1 to receive a single IM dose of nirsevimab 50 mg (if weight \< 5 kg) or 100 mg (if weight ≥ 5 kg) (N = 530) or placebo (N = 270). Randomization will be stratified by subject age at the time of randomization (≤ 3 months, \> 3 to ≤ 6 months, \> 6 months), and by GA (\< 35 weeks GA, ≥ 35 weeks GA). Enrollment of infants \> 6 months of age will be limited to approximately 100. All subjects will be followed through 1 year after dose administration. An independent data monitoring committee will review safety data regularly and make recommendations regarding further study conduct. Around 40 investigational study centres participate in the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
800
Drug: injection, 100 mg/mL, a single fixed IM dose of 50 mg (if weight \< 5 kg) or 100 mg (if weight ≥ 5 kg)on day 1 only.
Commercially available 0.9% (w/v) saline (sterile for human use) fixed IM dose of 0.5 mL (if weight \<5 kg) or 1.0 mL (if weight \>=5 kg)
Research Site
Beijing, China
Incidence of medically attended LRTI due to RT-PCR-confirmed RSV
The incidence of medically attended RSV LRTI (inpatient and outpatient) through 150 days post dose (ie, during a typical 5-month RSV season) for all infants, based on RSV test results (performed centrally using RT-PCR) and objective protocol-defined LRTI criteria, is the primary endpoint and will be presented by treatment groups. For subjects with multiple events, only the first occurrence will be used in the analysis. RSV LRTI that occurs through 150 days post dose will contribute to the primary efficacy analysis.
Time frame: Day 1 to Day 151
Incidence of RSV Hospitalization RT PCR-confirmed RSV
To assess the efficacy of nirsevimab in reducing hospitalizations due to protocol-defined LRTI caused by RT-PCR-confirmed RSV, compared to placebo
Time frame: Day 1 to Day 151
Safety and tolerability
Safety and tolerability of Nirsevimab as assessed by the occurrence of all treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAE) Safety of Nirsevimab will primarily be assessed and measured by the occurrence of all treatment-emergent AEs and SAEs. Other safety assessments will include the occurrence of Adverse Event of Special Interest (AESIs) and New Onset Chronic Diseases (NOCDs).
Time frame: Day 1 to Day 361
Summary of nirsevimab serum concentrations
To evaluate serum concentrations of nirsevimab.
Time frame: Day 1, Day 15, Day 151 & Day 361
Incidence of ADA to nirsevimab in serum
To evaluate ADA responses to nirsevimab in serum.
Time frame: Day 1, Day 151 & Day 361
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Research Site
Changde, China
Research Site
Changsha, China
Research Site
Changsha, China
Research Site
Chengdu, China
Research Site
Chengdu, China
Research Site
Guangzhou, China
Research Site
Guangzhou, China
Research Site
Guangzhou, China
Research Site
Hangzhou, China
...and 23 more locations