NCT07302256

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Shanghai Institute Of Biological Products · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	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
BIOLOGICAL	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
BIOLOGICAL	Phosphate buffer solution (PBS)	PBS, with a specification of 0.5mL/bottle.

Timeline

• Start date: 2025-12-16
• Primary completion: 2026-08-31
• Completion: 2026-08-31
• First posted: 2025-12-24
• Last updated: 2026-01-14

Locations

1 site across 1 country: China