Last updated 2 years ago

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

1600 patients around the world
Available in Chile
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.
Pontificia Universidad Catolica de Chile
4Research sites
1600Patients around the world
Requirements for the patient
From 3 Years
All Gender
Medical requirements
Sites
Hospital Félix Bulnes
Recruiting
Santiago, Metropolitana, 9110056
Centro de Investigaciones Médicas Respiratorias (CIMER) - Chile
Recruiting
Providencia, Metropolitana, 7500657
Hospital Puerto Montt
Recruiting
Puerto Montt, Los Lagos
Clínica Alemana
Recruiting
Av. Vitacura 5951, Vitacura, Región Metropolitana, Santiago
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