Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Influenza Vaccine, Inactivated · 2 trials · 2 indications
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. |
| Influenza Vaccine (Split Virion), Inactivated (High Dose) | EXPERIMENTAL | Participants will receive one dose of Influenza Vaccine (Split Virion), Inactivated (High Dose). |
| Influenza Vaccine (Split Virion), Inactivated | ACTIVE_COMPARATOR | Participants will receive one dose of the active control influenza vaccine. |
| 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. |
| Influenza Vaccine (Split Virion), Inactivated (High Dose) | BIOLOGICAL | A single 0.5 mL dose of the investigational high-dose split influenza virus vaccine will be administered by intramuscular (IM) injection into the deltoid muscle of the upper arm. Each dose contains 60 μg of hemagglutinin from each influenza virus strain used for the current influenza season. |
| Influenza Vaccine (Split Virion), Inactivated | BIOLOGICAL | A single 0.5 mL dose of the active control standard-dose split influenza virus vaccine will be administered by intramuscular (IM) injection into the deltoid muscle of the upper arm. Each dose contains 15 μg of hemagglutinin from each influenza virus strain used for the current influenza season. |
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...
Influenza Vaccine, Inactivated is used to prevent influenza, including seasonal influenza. It is an inactivated vaccine developed by Sinovac Biotech, Ltd. The candidate covers both influenza and seasonal influenza as its target indications within the infectious disease therapeutic area.
Influenza Vaccine, Inactivated is developed by Sinovac Biotech, Ltd, which trades under the ticker SVA. Sinovac is the sponsor behind the clinical program for this inactivated influenza vaccine candidate.
Influenza Vaccine, Inactivated is in Phase 1 development. The program includes a completed Phase 1 trial and a completed Phase 3 trial, and the candidate is investigational rather than approved. The Phase 1 study evaluated a high dose split virion inactivated formulation.
Two completed trials are registered for Influenza Vaccine, Inactivated. NCT07737106 was a Phase 1 trial of the high dose split virion inactivated formulation in 50 healthy volunteers aged 60 years and older in China. NCT05431725 was a Phase 3 immunogenicity and safety study of the quadrivalent formulation in 2,202 participants aged 3 years and older in Chile and the Philippines.
Yes. Influenza Vaccine, Inactivated is also known as Influenza Vaccine (Split Virion), Inactivated (High Dose), Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, and Influenza Vaccine, Inactivated, Quadrivalent. These names refer to the same Sinovac inactivated influenza vaccine program and its high dose and quadrivalent formulations.
The registered trials for Influenza Vaccine, Inactivated were randomized, double blind, and actively controlled. The Phase 3 study NCT05431725 enrolled 2,202 participants, and the Phase 1 study NCT07737106 enrolled 50 healthy volunteers. Both trials are listed as completed, and neither used biomarker-based patient selection.