Acute respiratory infection.
Conditions
Interventions
Sponsors
Hubei Provincial Center for Disease Prevention and Control
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Study participants aged 60 years or older, regardless of gender; 2. Participants voluntarily join the trial, sign the informed consent form, provide valid identification, and demonstrate understanding and compliance with the trial protocol requirements; 3. Axillary temperature < 37.3°C on the day of enrollment; 4. Inclusion criteria for postmenopausal women and male participants:Women must be postmenopausal (defined as no menstruation for 12 months without any other medical cause) and have no plans to become pregnant by any means.Male participants must practice strict contraception and avoid plans for fertility or sperm donation from the screening period until one month after vaccination. Effective contraceptive methods include oral contraceptives (excluding emergency contraceptives), injectable or implantable contraceptives, sustained-release local contraceptives, contraceptive patches, intrauterine devices, sterilization, abstinence, condoms, diaphragms, cervical caps, etc.
Exclusion criteria
Exclusion criteria: 1. Known allergy to the investigational vaccine or its excipients, or a history of anaphylactic shock or other severe adverse reactions to other vaccines; 2. Within 12 months prior to enrollment, a history of RSV-related respiratory infection confirmed by RT-PCR or RSV-Ab testing; 3. Previous vaccination with a respiratory syncytial virus (RSV) vaccine prior to enrollment; 4. Use of antipyretics, analgesics, or anti-allergic medications within 24 hours prior to enrollment; 5. Administration of any live vaccine within 28 days prior to vaccination, or any non-live vaccine within 14 days prior to vaccination; 6. Receipt of blood or blood-related products, including immunoglobulins, within 3 months prior to enrollment, or planned use during the study period; 7. Individuals with any of the following conditions: (1) Acute diseases of any kind or acute exacerbation of chronic diseases within the past 3 days; (2) Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; (3) Congenital or acquired immunodeficiency or a history of autoimmune diseases, or long-term use (continuous use >14 days) of glucocorticoids (dose >=20 mg/day prednisone or equivalent) or other immunosuppressants within the past 3 months. However, the following are allowed: inhaled or topical steroid use, or short-term use (course =160 mmHg and/or diastolic blood pressure >=100 mmHg); 8. Major surgery within 12 weeks prior to enrollment (as judged by the investigator), incomplete recovery from surgery, or planned major surgery during the study period; 9. History of chronic alcoholism and/or drug abuse; 10. Current or planned participation in other clinical trials; 11. Any condition or disease that, in the investigator’s opinion, may place the participant at unacceptable risk, interfere with protocol compliance, or compromise the evaluation of the vaccine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric mean titer (GMT) and geometric mean fold rise (GMFR) of serum neutralizing antibodies against RSV-A and RSV-B at 30 days after vaccination.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Serious Adverse Events (SAE) and Adverse Events of Special Interest (AESI) within 12 months after vaccination.;GMT and GMFR of neutralizing antibodies against RSV-A and RSV-B; GMC and GMFR of binding antibodies to the RSV prefusion F protein.;Adverse reactions and adverse events; | — |
Countries
China
Contacts
Public ContactYeqing Tong
Hubei Provincial Center for Disease Prevention and Control
Outcome results
None listed