Randomized, Blinded Phase III Study to Assess Safety and Immune Response of Quadrivalent Influenza Vaccine with ZFA02 Adjuvant in Adults

What this Trial Is About

Researchers are evaluating the safety, tolerability, and immune response to different doses of an Influenza Vaccine Split Virion, Inactivated, Quadrivalent, ZFA02 Adjuvant in this seamless Phase III clinical trial. The study aims to find the best dose for future trials by first increasing age and dose levels and then expanding the dose groups. It includes healthy adults starting from 18 years old and compares the new vaccine against a positive control vaccine, with a blinded and randomized design. The trial has two stages. In Phase I, participants aged 18 to 49 and 50 and above receive either low-dose or high-dose vaccines or placebo in four cohorts, with careful safety monitoring after vaccination. Phase II enrolls 500 subjects divided into two age groups 18-49 and 50, randomly assigned to low-dose, high-dose, or positive control vaccine groups. The study ensures a proper mix of older adults, including those aged 60 and above. Each participant receives a single vaccine dose according to their assigned group. Participants will be monitored closely with safety checks including blood and urine tests four days after vaccination and follow-up for adverse events up to 12 months. Researchers will assess vaccine-related side effects, immune response by measuring antibody levels 30 days post-vaccination, and other safety markers. The study includes careful observation of any serious adverse events and autoimmune reactions. The total participation time varies but involves multiple visits and assessments to ensure comprehensive safety and immune response data collection.

Clinical Trials of Quadrivalent Influenza Vaccine