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

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.

NCT Number	NCT07302256
Lead Sponsor	Shanghai Institute Of Biological Products
Conditions	Influenza
Enrollment	120 participants
Start Date	2025-12-16
Primary Completion	2026-08-31 (estimated)
Study Completion	2026-08-31 (estimated)
Updated on ClinicalTrials.gov	2026-01-14