Phase Ib/IIa Clinical Trial of SIBP-A16 Injection in Premature Infants and Full-term Infants

Exclusion Criteria

• •Any fever (≥37.5°C, axillary temperature) or acute illness (defined as the presence of moderate or severe symptoms or signs) occurring within 7 days prior to drug administration;
• •Having experienced Lower Respiratory Tract Infections (LRTI) within the previous 7 days prior to randomization, or having active LRTI at the time of randomization;
• •Individuals with chronic eczema or urticaria, or those with an allergic constitution who are allergic to multiple drugs, or those with a known history of allergy to immunoglobulin products, blood products, other exogenous proteins, or any components of this product;
• •Had a history of RSV infection before randomization, or had active RSV infection at the time of randomization;
• •Those who have received non-oral inactivated vaccines or component vaccines within 7 days before administration;
• •Having received a non-oral live attenuated vaccine within 30 days prior to drug administration;
• •Participants who have received any medication within 7 days prior to drug administration, except for: a) various vitamins and iron supplements; b) systemic over-the-counter medications (such as analgesics) for common pediatric symptoms, which may be used occasionally, as determined by the investigator;
• •Participants with autoimmune diseases who are currently receiving, or are expected to receive according to the investigator's judgment, immunosuppressive therapy (including steroids, excluding topical steroids) during the trial period;
• •Have previously used or are expected to receive blood products or immunoglobulin products during the trial period;
• •Known renal dysfunction or liver dysfunction;
• •Known to have chronic lung disease (CLD)/bronchopulmonary dysplasia;
• •Congenital respiratory abnormalities with clinical significance;
• •Suffering from congenital heart disease (CHD) accompanied by significant hemodynamic changes;
• •Suffering from chronic epilepsy or progressive or unstable neurological disorders;
• •Those who have previously experienced or are suspected to have experienced life-threatening acute events, and are still deemed unsuitable for participating in clinical trials by the researchers;
• •Known immune deficiency, including infection with human immunodeficiency virus (HIV);
• •The mother is infected with HIV (unless it has been proven that the trial participant is not infected);
• •The mother received the RSV vaccine during pregnancy;
• •Have received any investigational drugs or participated in any intervention studies;
• •Any other circumstances that the researcher believes may interfere with the evaluation of the study drug or the interpretation of the study results;
• •The participants are the children of the researchers, their subordinate researchers, relatives, or staff members of the sponsor.