drugset / Trial / NCT07582796
Clinical Trial of Recombinant RSV Vaccine (CHO Cell) (Adjuvanted) in Chinese Population Aged 18 Years and Older.
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The primary objective of the phase I trial is to evaluate the safety and tolerability of different doses of the recombinant respiratory syncytial virus vaccine (CHO cell) (Adjuvanted) in adults aged 18 years and older, with the secondary objective being to assess its immunogenicity. The primary objectives of the phase II trial are to evaluate the immunogenicity and safety of the recombinant respiratory syncytial virus vaccine (CHO cell) (Adjuvanted) with different adjuvant ratios in adults aged 60 years and older, with the secondary objective being to evaluate the persistence of immune responses.
Timeline
- Start
- 2026-05-14
- Primary completion
- 2027-09-14
- Completion
- 2029-08-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Low adjuvant) | Vaccine | 0.5 ml | Intramuscular |
| Subject | Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Single adjuvant) | Vaccine | 0.25 ml | Intramuscular |
| Subject | Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Single adjuvant) | Vaccine | 0.5 ml | Intramuscular |
| Subject | Recombinant Respiratory Syncytial Virus Vaccine(CHO cell)(Adjuvanted) | Vaccine | 0.25 ml | Intramuscular |
| Subject | Recombinant Respiratory Syncytial Virus Vaccine(CHO cell)(Adjuvanted) | Vaccine | 0.5 ml | Intramuscular |