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Immunogenicity and Safety Study of Influenza Vaccine (Split Virion), Inactivated, Quadrivalent

NCT05431725 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2202

Last updated 2024-05-28

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and immunogenicity of Influenza vaccine (Split virion), Inactivated, Quadrivalent developed by Sinovac Biotech Co., Ltd. (Sinovac-QIV) as compared to a licensed comparator in Chile and Philippines, Vaxigrip Tetra™ (Vaxigrip Tetra-QIV) in individuals aged 3 years and older.

Conditions

Interventions

BIOLOGICAL

Influenza Vaccine (Split Virion), Inactivated, Quadrivalent

The influenza vaccines (Split Virion), inactivated, quadrivalent are developed by Sinovac Biotech Co., Ltd.15 μg hemagglutinin (HA) of each of the four influenza strains in 0.5 mL of sodium chloride,disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.The routine of administration is intramuscular injection into deltoid region.

BIOLOGICAL

Control Quadrivalent influenza virus vaccine

The Control Quadrivalent influenza virus vaccines are manufactured by Sanofi and are purchased by Pontifical Catholic University of Chile.15μg HA of each of the four influenza strains in 0.5 mL of solution per injection.The routine of administration is intramuscular injection into deltoid region.

Sponsors & Collaborators

  • Sinovac Biotech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Zeng Gang, Senior Medical Director · Sinovac Biotech Co., Ltd

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-18
Primary Completion
2023-07-19
Completion
2023-07-19

Countries

  • Chile
  • Philippines

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 NCT05431725 on ClinicalTrials.gov