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RECRUITING
NCT07302256
PHASE1

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

Sponsor: Shanghai Institute Of Biological Products

View on ClinicalTrials.gov

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

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.

Locations (1)

Danjiangkou Disease Prevention and Control Center

Wuhan, Hubei, China