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

NCT07737106 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-07-30

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Sinovac Biotech Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-21
Primary Completion
2025-09-18
Completion
2026-02-24

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07737106 on ClinicalTrials.gov