lower respiratory tract disease induced by respiratory syncytial virus (RSV-LRTD)
Conditions
Interventions
Test vaccine group:SYS6016
Control vaccine group:Placebo
Sponsors
Hebei Province Center for Disease Prevention and Control
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Healthy participants aged 18 years or more; 2. Be able to understand the study procedure and comply with the requirements of the protocol for the planned follow-up visits, voluntarily consent to participate in the study and sign the informed consent form (ICF); 3. Being in good health at the discretion of investigators based on medical history inquiry, physical examination and laboratory test; for the participants having underlying disease (e.g., chronic disease such as diabetes/hypertension/hyperlipidemia), they should be controlled stably (no need for additional medical intervention or no major adjustment for treatment regimen) for at least 3 months before enrollment; 4. Elderly female participants should be non-childbearing potential; For adult female participants of childbearing potential: no sexual life or used effective contraceptive methods within one menstrual cycle before enrollment; no pregnancy plans and agree to used effective contraceptive methods from enrollment until 6 months after the full vaccination course; 5. For those whose laboratory test results are beyond the normal range before enrollment, if the result is in the range of Grade 1 (inclusive) standard specified in the Guidelines for Adverse Event Classification Standards for Clinical Trials of Preventive Vaccines (2019) issued by NMPA or other applicable adverse event classification standards referred in the protocol, can be enrolled.
Exclusion criteria
Exclusion criteria: 1. Have received RSV vaccine (including an investigational vaccine), or planning to receive RSV vaccine during the study; 2. Have a history of RSV infection within 6 months before enrollment, based on investigators’ inquiry; 3. Axillary temperature = 37.1°C on the day of enrollment or within 24 h before enrollment; 4. History of allergy to any component of the investigational vaccine or history of severe allergic reaction to vaccines or drugs (including but not limited to anaphylaxis, allergic laryngeal edema, anaphylactoid purpura, thrombocytopenia purpura or local allergic necrosis [Arthus reaction]); 5. History of myocarditis, pericarditis, or idiopathic cardiomyopathy, or any condition that would increase the risk of myocarditis or pericarditis; 6. History of demyelinating diseases, including but not limited to Guillain-Barré syndrome, multiple sclerosis, ophthalmoneuromyelitis, acute disseminated encephalomyelitis, etc. 7. Current illness of epilepsy or convulsion, neurological or psychiatric disorders; 8. Have contraindications to intramuscular injection, e.g., diagnosed thrombocytopenia, any coagulation disorders, or being treated with anticoagulants, etc; 9. Active malignant tumor, malignant tumor without adequate treatment, malignant tumor with a potential risk of recurrence during the study; 10. Active, unstable, severe or uncontrolled cardiovascular and cerebrovascular disease, thrombotic diseases, blood and lymphatic system diseases, liver and kidney diseases, respiratory diseases, metabolic disease, musculoskeletal diseases, autoimmune diseases at enrollment; 11. Have diagnosed immunocompromise or immunosuppression, congenital or functional asplenia, or splenectomy; 12. Have systematacially received immunosuppressants, immunostimulants, or other immunomodulatory drugs (e.g., corticosteroids, = 20 mg/d prednisone or equivalent) for a long time (defined as 14 days or more), within 6 months before vaccination; inhaled and topical steroids are allowed; or planning to receive the aforementioned drugs during the study; 13. Have received whole blood, plasma, serum, immunoglobulins, or monoclonal antibodies within 3 months before enrollment, or planning to receive these products during the study; 14. Blood donation or blood loss = 450 mL within 1 month before enrollment, or planning to donate blood during the study; 15. Have received any other vaccine within 30 days before enrollment, or planning to receive any other vaccine within 30 days after the last dose; 16. Those who are participating in or planning to participate in other clinical trials during the study; 17. For female participants of childbearing potential: having positive urine pregnancy test before vaccination, being in pregnancy or lactation; 18. As determined by the investigator, unable to comply with study procedures or adhere to requirements; or there are other conditions that make the participation in this study inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Solicited adverse events;Unsolicited adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serious Adverse Events (SAEs) ;Adverse Events of Special Interest (AESI) ;Pregnancy Events;Geometric mean titer (GMT) and geometric mean fold increase (GMFI) of neutralizing antibodies against RSV-A and RSV-B;Geometric mean concentration (GMC) and GMFI of specific IgG antibodies against RSV F protein; | — |
Countries
China
Contacts
Public ContactZhiwei Wu
Hebei Province Center for Disease Prevention and Control
Outcome results
None listed