Respiratory Syncytial Virus Infection
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
No minimum to 1 Years
Inclusion criteria
Inclusion criteria: 1. Healthy late preterm infants and term infants (gestational age >=35 weeks) within 1 year of age; infants with underlying conditions (e.g., Down syndrome and cleft lip) but no other risk factors are permitted to participate; 2. Infants entering or currently experiencing their first RSV infection season at the time of randomization; 3. Informed consent has been obtained from the subject's parent(s)/legal guardian(s); 4. The subject's parent(s)/legal guardian(s) are able to understand and comply with the protocol requirements and procedures, including scheduled center visits, telephone follow-ups, and sample collection.
Exclusion criteria
Exclusion criteria: 1. Any fever (body temperature >=38.0°C, regardless of measurement method) or acute illness (defined as moderate or severe symptoms or signs) within 7 days prior to dosing; 2. Lower respiratory tract infection within 7 days prior to dosing; 3. History of urticaria, known allergies to multiple medications, or known allergies to immunoglobulin products or blood products; 4. Current active RSV infection or prior history of RSV infection; 5. Receipt of any medical treatment (e.g., long-term or temporary medication) within 7 days prior to dosing, except for: a) Various vitamins, iron supplements, DHA, etc.; b) Over-the-counter medications for common pediatric symptoms (e.g., pain relievers, topical treatments) as occasionally used at the investigator's discretion; 6. Patients with autoimmune diseases currently receiving or expected to receive immunomodulatory therapy during the trial (e.g., systemic glucocorticoids, excluding topical applications) at the investigator's discretion; 7. Use of blood products, immunoglobulin preparations, or monoclonal/polyclonal antibodies within the past 3 months or anticipated use during the trial (excluding the investigational product); 8. Known renal impairment or hepatic dysfunction at screening (including known or suspected active or chronic hepatitis infection); 9. Known chronic lung disease (CLD)/bronchopulmonary dysplasia or clinically significant congenital respiratory anomalies; 10. Congenital heart disease (CHD) with significant hemodynamic changes, except isolated CHD (e.g., patent ductus arteriosus, non-hemodynamically significant atrial septal defect, or small ventricular septal defect); 11. Chronic epilepsy or progressive/unstable neurological disease; 12. History of life-threatening acute events (or suspected occurrence thereof), with investigator determination of current ineligibility for clinical trial participation; 13. Known immunodeficiency, including human immunodeficiency virus (HIV) infection; 14. Maternal HIV infection (unless proven negative in subject); 15. Received any anti-RSV monoclonal antibody or RSV vaccine, including maternal RSV vaccination during pregnancy; 16. Received any investigational drug or participated in any interventional study; 17. Any other condition deemed by the investigator to potentially interfere with the assessment of the study drug or interpretation of study results; 18. Subject is the child of the investigator, a subordinate investigator, or a sponsor staff member.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of medically attended lower respiratory tract infections (MALRTI) caused by RSV, confirmed by RT-PCR, within 150 days after dosing.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hospitalization rate due to RSV infection confirmed by RT-PCR causing MALRTI within 150 days post-administration (i.e., D1-D151);;During the study period, the occurrence of adverse events (AE)/serious adverse events (SAE) and adverse events of special interest (AESI) (type, incidence rate, severity, and causality);;Establish a population pharmacokinetic (PopPK) model for RB0026 injection in the pediatric population to characterize its PK profile and evaluate the impact of intrinsic/extrinsic factors on the PK characteristics of RB0026.;Serum anti-RSV neutralizing antibody titers and fold increases at different time points post-administration;;Serum anti-drug antibody (ADA) positivity rate and neutralizing antibody (NAb) activity at different time points post-administration;Analysis of Respiratory Syncytial Virus Genotypes and F Protein Antigenic Site Mutation Rates, and Determination of Affinity for RB0026 Injection Solution;;The incidence of medically active lower respiratory tract infections (MALRTI) caused by RSV, confirmed by RT-PCR, occurring between 151 and 240 days after dosing (i.e., D152–D241);;Hospitalization rate due to RSV infection confirmed by RT-PCR causing MALRTI within 151–240 days post-administration (i.e., D152–D241); | — |
Countries
China
Contacts
Public ContactZhong Nanshan, Sun Lihong
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed