Phase 1/2Recruiting
Clinical Trials of Quadrivalent Influenza Vaccine
A Randomized, Blinded Phase I./II Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. (Industry)
- Enrolment
- 620 planned
- Conditions
- Influenza, Human
- Interventions
- Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (low dose); Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant placebo (low dose); Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (high dose); Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant placebo (high dose); Influenza Vaccine (Split Virion), Inactivated, Quadrivalent
- Ages
- adults, older adults
- Registry
- NCT06824519
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- AE occurren
- AESI occurrences
- SAE occurrences
- Serum alanine aminotransferase level
History
Study completion
Last registry update
Primary completion
Started
Registered