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COMPLETED
NCT07737106
PHASE1

Phase I/II Clinical Trial of Influenza Vaccine (Split Virion), Inactivated (High Dose)

Sponsor: Sinovac Biotech Co., Ltd

View on ClinicalTrials.gov

Summary

This is a randomized, double-blind, active-controlled Phase I clinical trial to evaluate the safety and immunogenicity of Influenza Vaccine (Split Virion), Inactivated (High Dose) developed by Sinovac.

Official title: A Randomized, Double-blind, Active-controlled Phase I/II Clinical Trial to Evaluate the Safety and Immunogenicity of Influenza Vaccine (Split Virion), Inactivated (High Dose) in Adults Aged 60 Years and Older

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-08-21

Completion Date

2026-02-24

Last Updated

2026-07-30

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

Influenza Vaccine (Split Virion), Inactivated (High Dose)

A single 0.5 mL dose of the investigational high-dose split influenza virus vaccine will be administered by intramuscular (IM) injection into the deltoid muscle of the upper arm. Each dose contains 60 μg of hemagglutinin from each influenza virus strain used for the current influenza season.

BIOLOGICAL

Influenza Vaccine (Split Virion), Inactivated

A single 0.5 mL dose of the active control standard-dose split influenza virus vaccine will be administered by intramuscular (IM) injection into the deltoid muscle of the upper arm. Each dose contains 15 μg of hemagglutinin from each influenza virus strain used for the current influenza season.

Locations (1)

Urad Middle Banner Center for Disease Control and Prevention

Bayan Nur, Inner Mongolia, China