Safety and Immunogenicity of the Recombinant Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 18 Years and Older

Exclusion Criteria

• •1. Allergy to the investigational vaccine or its excipients, or a history of anaphylactic shock or other serious adverse reactions to other vaccines;
• •2. Previous vaccination against Respiratory Syncytial Virus;
• •3. A confirmed diagnosis or etiological evidence of respiratory syncytial virus infection and related diseases caused by the infection within 12 months before enrollment;
• •4. Has taken antipyretics, analgesics or anti-allergy drugs within 24 hours before enrollment;
• •5. Has received any vaccine within 14 days before vaccination, or have received a live vaccine within 28 days;
• •6. Has received blood or blood-related products, including immunoglobulin, within 3 months prior to enrollment; or plan to use them during the study period;
• •7. Individual with the following diseases:
• •* Has acute diseases or are in the acute exacerbation period of chronic diseases within 3 days before vaccination;
• •* Diagnosed with congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
• •* History of congenital or acquired immunodeficiency or autoimmune diseases;
• •* Chronic administration (≥14 consecutive days) of corticosteroids (dose ≥ 20 mg/day prednisone or equivalent dose) or other immunosuppressants within the past 3 months, with the exception of inhaled or topical steroids, or short-term use (\<14 consecutive days) of oral corticosteroids;
• •* Neurological diseases or family history (seizures, epilepsy, encephalopathy, etc.); history of psychiatric disorders or family history;
• •* Asplenia or functional asplenia;
• •* Severe or uncontrolled or hospitalization-required cardiovascular diseases, diabetes, blood and lymphatic system diseases, immune system diseases, liver and kidney diseases, respiratory system diseases, metabolic and skeletal system diseases, or malignant tumors;
• •* Contraindications for intramuscular injection and blood drawing, such as coagulation disorders, thrombosis or hemorrhagic diseases, or situations requiring continuous use of anticoagulants;
• •* Severe hypertension that cannot be controlled by medication (measured on-site: systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg);
• •8. History of major surgery within 12 weeks prior to enrollment (as determined by the investigator), or not fully recovered from the surgery, or having plans for major surgery during the anticipated period of the subject's participation in the study;
• •9. History of long-term alcohol abuse and/or drug abuse;
• •10. Individual who is currently participating in other research or unregistered product (drugs, vaccines, or devices, etc.) clinical studies, or plan to participate in other clinical studies before the end of this clinical study;
• •11. Other conditions that may impact the subject's safety or influence the assessment of vaccine response, as determined by the investigator;