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.
The study is designed to evaluate the immunogenicity of the quadrivalent inactivated-virus influenza vaccine developed by Sinovac Biotech Co., Ltd against Vaxigrip Tetra™. The population included in the study is healthy subjects 3 years and older, being 800 individuals 10 years old or less and 800 over 18 years, randomized 1:1 to experimental vaccine or Vaxigrip Tetra™. Volunteers 8 years old or less, without history of previous influenza infection will receive 2 doses of vaccine, al other individuals will receipt 1 dose of vaccine. Immunogenicity will be assessed one month after the last dose of vaccine, humoral responses will be determined for all patients meanwhile ome subgroup of patients will have a determination of cellular immunity also. Subjects will be follow up for one month, adverse events will be assessed during this time.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,600
15μg Hemagglutinin Antigen (HA) of each of the four strains
Hospital Puerto Montt
Port Montt, Los Lagos Region, Chile
RECRUITINGCentro de Investigaciones Médicas Respiratorias (CIMER)
Providencia, Santiago Metropolitan, Chile
RECRUITINGHospital Clínico UC Christus
Santiago, Santiago Metropolitan, Chile
RECRUITINGHospital Félix Bulnes
Santiago, Santiago Metropolitan, Chile
RECRUITINGClínica Alemana de Santiago
Vitacura, Santiago Metropolitan, Chile
RECRUITINGSeroconversion for influenza
Seroconversion rates and geometric mean titers of human influenza antibody for each of the four antigens.
Time frame: 28 days after the last dose of vaccination
Antibody titer 1:40 or more
Proportion of subjects with antibody titer ≥1:40
Time frame: 28 days after the last dose of vaccination
Cellular immunity-ELISPOT
Quantification by ELISPOT of specific Spot Forming Cells for cytokines, molecules and immunoglobulins induced by both vaccines
Time frame: 28 days after the last dose
Cellular immunity-Cytometry
Quantification by flow cytometry of CD3+CD4+ and CD3+CD8+ cells positive for Activation Induced Markers, induced by both vaccines.
Time frame: 28 days after the last dose
Cellular immunity-Luminex (TM)
• Quantification by Luminex® of cytokines secreted by specific CD3+CD4+ and CD3+CD8+ cells induced by each vaccine
Time frame: 28 days after the last dose
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