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.
This study is a phase Ⅲ, double-blind, randomized and active-controlled clinical trial 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, Vaxigrip Tetra™ (Vaxigrip Tetra-QIV) in individuals aged 3 years and older. Subjects will be randomized 1:1 to received either Sinovac-QIV or Vaxigrip Tetra-QIV. Vaccine-primed subjects will receive one 0.5ml dose of Sinovac-QIV or Vaxigrip Tetra-QIV on day 0. Vaccine-unprimed subjects will receive two 0.5ml doses of Sinovac-QIV or Vaxigrip Tetra-QIV and day 0 and day 28, respectively. Subjects who are 3-8 years of age had prior receipt of ≥2 doses of influenza vaccine at least 4 weeks apart or who are ≥9 years old are considered "vaccine-prime". Subjects who are 3-8 years of age had prior receipt of \<2 dose of influenza vaccine are considered "vaccine-unprimed".
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
2,202
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.
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.
Hospital de Puerto Montt
Port Montt, Chile
CIMER Center/Center for Medical Research on Respiratory Diseases
Santiago, Chile
Clínica Alemana
Santiago, Chile
Hospital Clínico UC-Christus
Seroconversion rates of HI antibody
Seroconversion rates of HI antibody at day 28 after the last dose for each of the four antigens.
Time frame: At day 28 after the last dose
GMTs of HI antibody
GMTs of HI antibody at day 28 after the last dose for each of the four antigens.
Time frame: At day 28 after the last dose
Seroprotection rates(SCRs) of HI antibody
Proportion of subjects with antibody titer ≥1:40 at day 28 after the last dose
Time frame: At day 28 after the last dose
Seroconversion rates (SCRs) of HI antibody
Seroconversion rates at day 28 after the last dose.
Time frame: At day 28 after the last dose
Solicited local and systemic Adverse Events (AEs)
Occurrence, intensity, duration, and relationship of solicited local and systemic Adverse Events (AEs) within 7 days after each dose.
Time frame: Within 7 days after each dose
Unsolicited AEs
Occurrence, intensity, duration, and relationship of unsolicited AEs within 28 days after each dose.
Time frame: Within 28 days after each dose
Serious adverse events (SAEs)
Occurrence and relationship of serious adverse events (SAEs) within 28 days after each dose
Time frame: Within 28 days after each dose
Adverse events of special interest (AESI)
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Santiago, Chile
Hospital Felix Bulnes
Santiago, Chile
Universidad San Sebastián
Santiago, Chile
Clinica Alemana de Valdivia
Valdivia, Chile
Las Pinas Doctors Hospital
Las Piñas, Manila, Philippines
Tropical Disease Foundation Inc
Makati City, Manila, Philippines
San Juan De Dios Hospital
Pasay, Manila, Philippines
...and 1 more locations
Adverse events of special interest (AESI) within 28 days after each dose
Time frame: Within 28 days after each dose