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Phase Ⅲ, Clinical Trial to Compare an Inactivated Quadrivalent Influenza Vaccine and a Licensed Vaccine in Chile

NCT05494047 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1600

Last updated 2022-08-09

No results posted yet for this study

Summary

This study compares the immunogenity and safety of quadrivalent inactivated influenza vaccines. The experimental group receives the quadrivalent influenza vaccine developed by Sinovac Biotech Co., Ltd and the control group immunized with Vaxigrip Tetra™. The group has 1600 persons from general population 3 years and older. The design is double-blind and randomized. The primary outcome is the immunogenicity against the 4 strains of influenza included in both vaccines.

Conditions

Interventions

DRUG

Tetravalent influenza vaccine developed by Sinovac Biotech Co.

15μg Hemagglutinin Antigen (HA) of each of the four strains

Sponsors & Collaborators

  • Sinovac Biotech (Chile) SpA

    collaborator INDUSTRY

  • Sinovac Biotech Co., Ltd

    collaborator INDUSTRY

  • Pontificia Universidad Catolica de Chile

    lead OTHER

Principal Investigators

  • Pablo A Gonzalez, PhD · Pontifical Catholic University of Chile

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-14
Primary Completion
2023-05-31
Completion
2023-07-31

Countries

  • Chile

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 NCT05494047 on ClinicalTrials.gov