A Clinical Trial of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried
The Phase 1 clinical trial of the freeze-dried human rabies vaccine (human diploid cells) will be conducted on participants aged 10 to 60. This study will design a single-arm, randomized, open-access trial with different immunization schedules (5-dose schedule and 2-1-1 schedule) to evaluate the safety and tolerability
| Condition(s) | Rabies |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | The Phase 1 clinical trial of the freeze-dried human rabies vaccine (human diploid cells) will be conducted on participants aged 10 to 60. This study will design a single-arm, randomized, open-access trial with different immunization schedules (5-dose schedule and 2-1-1 schedule) to evaluate the safety and tolerability of the vaccine in participants aged 10 to 60 |
| Who can participate | Inclusion Criteria: * (1) The participants' ages range from 10 to 60 years old (≥10 years old and \<61 years old). (2) Participants aged 10 to 17 and their guardians can provide valid identification documents, and participants aged 18 to 60 can provide their own valid identification documents. (3) Participants aged 10 to 17 and their guardians, as well as participants aged 18 to 60, can sign the informed consent form voluntarily to participate in the trial, fully understand the trial procedures, the risks of participating in the trial, and other intervention measures that can be chosen if they do not participate in the trial, etc. (4) Possess basic reading and writing skills, and be capable of reading, understanding and filling in diary cards and contact cards; (5) Female participants with |
| Ages | 10 Years to 60 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Ningbo Rongan Biological Pharmaceutical Co., Ltd. |
| Locations | Zhengzhou, Henan, China |
| Start date | 2025-05-23 |
| NCT ID | NCT07021703 |
| Official listing | https://clinicaltrials.gov/study/NCT07021703 |