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Quadrivalent Influenza Split Virion Vaccine Phase III Trial in ≥3-year-old Healthy Population

CTR20230911Phase 3Completed

Sponsor
Shenzhen Kangtai Biological Products
Start
Apr 2023
Modality
Vaccines & Immunotherapeutics
Countries
1
01

Overview

Phase 3, randomised, double-blind trial of influenza vaccine (split virion, inactivated, quadrivalent) in influenza (2 arms), sponsored by Shenzhen Kangtai Biological Products. Primary endpoints: Seroconversion rate (SCR) and geometric mean titer (GMT) of HI antibodies for 4 vaccine strains at Day 28 in ≥3-year-old healthy participants (non-inferiority vs. control), Seroconversion rate (SCR) and seroprotection rate (SPR) of HI antibodies at Day 28 in <60-year-old healthy participants and 1 more. Started Apr 2023; status: completed.

02

Drugs

influenza vaccine (split virion, inactivated, quadrivalent)
03

Conditions

influenza

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