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RECRUITING
NCT06824519
PHASE1/PHASE2

Clinical Trials of Quadrivalent Influenza Vaccine

Sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: A Randomized, Blinded Phase I./II Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

620

Start Date

2025-05-08

Completion Date

2026-09

Last Updated

2025-11-20

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (low dose)

Inject 1 dose of low-dose vaccine

BIOLOGICAL

Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant placebo (low dose)

Inject 1 dose of low-dose placebo

BIOLOGICAL

Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (high dose)

Inject 1 dose of high-dose vaccine

BIOLOGICAL

Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant placebo (high dose)

Inject 1 dose of high-dose placebo

BIOLOGICAL

Influenza Vaccine (Split Virion), Inactivated, Quadrivalent

Inject 1 dose of positive control vaccine

Locations (1)

Hebei Province Centers for Disease Control and Prevention

Shijiazhuang, Hebei, China