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A Clinical Trial of Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above
Sponsor: Shanghai Institute Of Biological Products
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.
Official title: 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
Key Details
Gender
All
Age Range
60 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-12-16
Completion Date
2026-08-31
Last Updated
2026-01-14
Healthy Volunteers
Yes
Conditions
Interventions
Influenza 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
Influenza 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
Phosphate buffer solution (PBS)
PBS, with a specification of 0.5mL/bottle.
Locations (1)
Danjiangkou Disease Prevention and Control Center
Wuhan, Hubei, China