Clinical Trials of Quadrivalent Influenza Vaccine
This clinical trial adopts a seamless design of phase I/II, conducted in two stages: phase I and phase II. Phase I is the age/dose ramp up stage, and phase II is the dose expansion stage.The purpose of this clinical trial is to evaluate the safety and tolerability of different doses of Influenza Vaccine (Split Virion),
| Condition(s) | Influenza, Human |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | This clinical trial adopts a seamless design of phase I/II, conducted in two stages: phase I and phase II. Phase I is the age/dose ramp up stage, and phase II is the dose expansion stage.The purpose of this clinical trial is to evaluate the safety and tolerability of different doses of Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant，explore the immunogenicity of the vaccine, and determine the appropriate dose for later clinical trials of this product. |
| Who can participate | Inclusion Criteria: 1. When signing the informed consent form, be at least 18 years old and provide valid identification; 2. The subject is able to understand the procedures and methods of this clinical trial, has given sufficient informed consent, voluntarily participated, and signed an informed consent form by the subject themselves; 3. On the day of enrollment, axillary temperature was ≤ 37.0 ℃; 4. Female and male participants of childbearing age: agree to take effective contraceptive measures within 6 months after vaccination. Exclusion Criteria: 1. The laboratory test indicators specified in the protocol are abnormal and clinically significant before vaccination (only for Phase I); 2. Have contracted influenza within the past 6 months prior to enrollment (confirmed by any clinical or |
| Ages | 18 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. |
| Locations | Shijiazhuang, Hebei, China |
| Start date | 2025-05-08 |
| NCT ID | NCT06824519 |
| Official listing | https://clinicaltrials.gov/study/NCT06824519 |