This is a randomised, double-blind, placebo-controlled Phase 1/2 clinical trial to evaluate the safety, tolerability and immunogenicity of recombinant respiratory syncytial virus in participants aged 18 years and older.
Phase I: male and female participants ≥18 years old at the time of signing the ICF; Phase II: male and female participants ≥50 years of age at the time of signing the ICF.
Be able to sign a written Informed consent form (ICF) and participate in the trial voluntarily, and can fully understand the trial procedures and risks of participating in the trial.
Be able to complete the diary card, contact card and diary/contact card by own or with the assistance of others.
Phase I: healthy subjects or healthy subjects judged by the investigator according to the clinical data of the subjects; Stage II: Subjects who are healthy or have a stable underlying disease.
Acute illness and/or fever (axillary temperature ≥37.3 ° C) occurred within 3 days prior to vaccination with the study vaccine, or antipyretic, analgesic, or antiallergic drugs.
Use any investigational or unregistered product within 30 days prior to immunization, or plan to use any such product during the study period.
Concurrent participation in another clinical study where the subject has been or will be exposed to an investigational or non-investigational vaccine/product at any time during the study.
Long-term or high-dose glucocorticoid therapy (duration ≥15 days, or dose ≥1 mg/kg/ day of prednisone or equivalent doses of other glucocorticoids), or other immunosuppressive and cytotoxic therapy within 90 days prior to vaccination.
Parallel
SCTV02
Biological/VaccineParticipants will receive a singe dose of SCTV02 on Day 0.
Placebo
Biological/VaccineParticipants will receive a singe dose of Placebo on Day 0.
10
Treatment groupsSee each treatment group below.
Incidence and severity of solicited adverse events within 7 days post study vaccination.
Incidence and severity of solicited adverse events within 7 days post study vaccination.
Geometric mean titer (GMT) of neutralizing antibodies (nAb) against RSV-A and RSV-B subtypes 30 days post vaccination
Geometric mean titer (GMT, Live Virus Neutralization Test) of neutralizing antibodies (nAb) against RSV-A and RSV-B subtypes 30 days after study vaccination.
GMT of nAb against RSV-A and RSV-B subtypes 14 days after study vaccination.Immunogenicity 14 days post vaccination
GMT of nAb against RSV-A and RSV-B subtypes 14 days after study vaccination.
GMT of nAb against RSV-A and RSV-B subtypes 90 days post vaccination
GMT (Live Virus Neutralization Test) of neutralizing antibodies (nAb) against RSV-A and RSV-B subtypes 90 days after study vaccination.
GMT of nAb against RSV-A and RSV-B subtypes 180 days post vaccination
GMT (Live Virus Neutralization Test) of neutralizing antibodies (nAb) against RSV-A and RSV-B subtypes 180 days after study vaccination.
GMT of nAb against RSV-A and RSV-B subtypes 365 days post vaccination
GMT (Live Virus Neutralization Test) of neutralizing antibodies (nAb) against RSV-A and RSV-B subtypes 365 days after study vaccination.
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