drugset / Trial / NCT07302256

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

NCT07302256 ↗

Phase 1 Recruiting 120 enrolled Shanghai Institute Of Biological Products
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2025-12-16
Primary completion
2026-08-31
Completion
2026-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Influenza virus split vaccine Vaccine 0.5 ml Intramuscular
Subject Influenza virus split vaccine Vaccine 0.7 ml Intramuscular

Indications