RecruitingPhase 1NCT07302256

A Clinical Trial of Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above

A Randomized, Double-blind, Controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of the Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above

Sponsor

Shanghai Institute Of Biological Products

Enrollment

120 participants

Start Date

Dec 16, 2025

Study Type

INTERVENTIONAL

Conditions

Influenza

Summary

This is a randomized, blinded, controlled phase I clinical trial with a total of 120 participants aged ≥ 60 years. Experimental group: Influenza virus split vaccine (0.7mL/vial), control group 1: Influenza virus split vaccine, control group 2: placebo group. The three groups were recruited at a ratio of 1:1:1, and 40 individuals were randomly vaccinated in each group. Each person was injected with one dose of the vaccine into the deltoid muscle of the upper arm. Participants in each study group are required to undergo laboratory indicator tests before and on the 4th day after vaccination.

Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Influenza virus split vaccine, a biological treatment called Influenza virus split vaccine (0.7mL/vial), and others for people with influenza. The study is currently recruiting participants at 1 location. People eligible for this study include aged 60 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALInfluenza virus split vaccine (0.7mL/vial)

Influenza virus split vaccine, with a specification of 0.7mL/bottle, containing 60 μ g of hemagglutinin from H1N1, H3N2, and B influenza virus strains each

BIOLOGICALInfluenza virus split vaccine

Influenza virus split vaccine, with a specification of 0.5mL/bottle, containing 15 μ g of hemagglutinin from H1N1, H3N2, and B influenza virus strains each

BIOLOGICALPhosphate buffer solution (PBS)

PBS, with a specification of 0.5mL/bottle.