Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05431725 | Immunogenicity and Safety Study of Influenza Vaccine (Split Virion), Inactivated, Quadrivalent | PHASE3 | COMPLETED | 2,202 | — | — | Jul 18, 2022 | Jul 19, 2023 | May 28, 2024 | 11 | Chile, Philippines |
Seroconversion rates of HI antibody at day 28 after the last dose for each of the four antigens.
GMTs of HI antibody at day 28 after the last dose for each of the four antigens.
| Arm | Type | Description |
|---|---|---|
| Sinovac-QIV group | EXPERIMENTAL | 800 subjects aged 3 years and older will receive one dose of Sinovac-QIV for vaccine-primed subjects or two doses of Sinovac-QIV for vaccine-unprimed subjects. |
| Vaxigrip Tetra-QIV group | ACTIVE_COMPARATOR | 800 subjects aged 3 years and older will receive one dose of Vaxigrip Tetra-QIV for vaccine-primed subjects or two doses of Vaxigrip Tetra-QIV for vaccine-unprimed subjects. |
| Name | Type | Description |
|---|---|---|
| Influenza Vaccine (Split Virion), Inactivated, Quadrivalent | BIOLOGICAL | 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. |
| Control Quadrivalent influenza virus vaccine | BIOLOGICAL | 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. |
Inclusion Criteria: * Volunteers age 3 years and older, in good health or medically stable; * Written informed consent obtained from subjects or/and legal guardian; * No receipt of influenza vaccines within 6 months or plans to receive any influenza vaccines during the study; * Female subjects of n...