Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Quadrivalent influenza vaccine, Participants will receive one dose of vaccine of Sinovac QIV
Quadrivalent influenza vaccine (split virion), inactivated · 5 trials · 2 indications
SCR 28 days after vaccination.
SPR 28 days after vaccination.
GMT 28 days after vaccination.
GMI 28 days after vaccination.
Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, B Victoria and B Yamagata. Seroconversion was defined as pre-vaccination titer \<1：10 and post-vaccination titer ≥1:40, and Significant increase was defined as pre-vaccination titer≥1:40 and ≥ 4-fold increase of post-vaccination titer.
Anti-influenza antibody levels were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, B Victoria, B Yamagata.
Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, B Victoria and B Yamagata. Seroprotection was defined as an antibody titer ≥1:40 at pre-vaccination and at post-final vaccination.
HI antibody seroconversion rate 28 days after full schedule immunization
HI antibody seroprotection rate 28 days after full schedule immunization
HI antibody GMT increase folds 28 days after full schedule immunization
Incidence of adverse reaction 0-28 days after each dose
The incidence of abnormal blood biochemical indexes 3 days after each dose
Incidence of SAE since the beginning of vaccination until 6 months after full course vaccination
Immunogenicity index, One of the standard to evaluate the experimental vaccine is non-inferior to the control vaccines.
Immunogenicity index, Another standard to evaluate the experimental vaccine is non-inferior to the control vaccines.
Immunogenicity index, One of the standard to evaluate the experimental vaccine is non-inferior to the control vaccines
Immunogenicity index, Another standard to evaluate the experimental vaccine is non-inferior to the control vaccines
| Arm | Type | Description |
|---|---|---|
| Test Group | EXPERIMENTAL | Participants will receive one dose of vaccine (0.5 mL) of Sinovac QIV |
| Control Group | ACTIVE_COMPARATOR | Participants will receive one dose of vaccine (0.5 mL) of Vaxigrip QIV |
| Experimental Group of quadrivalent influenza vaccine(0.25ml) | EXPERIMENTAL | 1100 subjects phase III will receive two doses of quadrivalent influenza vaccine(0.25ml) according to the immunization schedule of day 0,28 |
| Experimental Group of quadrivalent influenza vaccine(0.5ml) | EXPERIMENTAL | 1100 subjects phase III will receive two doses of quadrivalent influenza vaccine(0.5ml) according to the immunization schedule of day 0,28 |
| Control Group of trivalent influenza vaccine(BV) | ACTIVE_COMPARATOR | 550 subjects phase III will receive two doses of trivalent influenza vaccine(BV) according to the immunization schedule of day 0,28. |
| Control Group of trivalent influenza vaccine(BY) | ACTIVE_COMPARATOR | 550 subjects phase III will receive two doses of trivalent influenza vaccine(BY) according to the immunization schedule of day 0,28. |
| Safety group | EXPERIMENTAL | PhaseⅠ,30 subjects will receive two doses of quadrivalent influenza vaccine(0.5ml) on the immunization schedule of day 0,28. |
| Experimental group-phase Ⅰ | EXPERIMENTAL | Quadrivalent influenza vaccine |
| Experimental group-phase Ⅲ | EXPERIMENTAL | Quadrivalent influenza vaccine |
| Control group 1-phase Ⅲ | ACTIVE_COMPARATOR | Trivalent influenza vaccine (contains B/Victoria strain) |
| Control group 2-phase Ⅲ | ACTIVE_COMPARATOR | Trivalent influenza vaccine (contains B/Yamagata strain) |
| Experimental group-phase I | EXPERIMENTAL | Quadrivalent influenza vaccine |
| Experimental group-phase III | EXPERIMENTAL | Quadrivalent influenza vaccine |
| Control group-1-phase III | ACTIVE_COMPARATOR | Trivalent influenza vaccine (contains B/Victoria strain) |
| Control group-2-phase III | ACTIVE_COMPARATOR | Trivalent influenza vaccine (contains B/Yamagata strain) |
| Name | Type | Description |
|---|---|---|
| Participants will receive one dose of vaccine (0.5 mL) of Sinovac QIV | BIOLOGICAL | Participants will receive one dose of vaccine (0.5 mL) of Sinovac QIV |
| Vaxigrip QIV | BIOLOGICAL | Participants will receive one dose of vaccine (0.5 mL) of Vaxigrip QIV |
| Quadrivalent influenza vaccine(0.25ml) | BIOLOGICAL | 7.5 ug hemagglutinin (HA) of each of the four influenza strains in 0.25 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per njection.The routine of administration is Intramuscular injection into deltoid region.And the immunization schedule is two doses on day 0, 28. |
| Quadrivalent influenza vaccine(0.5ml) | BIOLOGICAL | 15 ug hemagglutinin (HA) of each of the four influenza strains in 0.5 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per njection.The routine of administration is Intramuscular injection into deltoid region.And the immunization schedule is two doses on day 0, 28. |
| Trivalent influenza vaccine(BV) | BIOLOGICAL | 7.5μg inactivated influenza antigen (H1N1, H3N2, Victoria) of each of the trivalent influenza vaccine in 0.25 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.The routine of administration is Intramuscular injection into deltoid region. And the immunization schedule is two doses on day 0, 28. |
| Trivalent influenza vaccine(BY) | BIOLOGICAL | 7.5μg inactivated influenza antigen (H1N1, H3N2, and Yamagata) of each of the trivalent influenza vaccine in 0.25 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.The routine of administration is Intramuscular injection into deltoid region.And the immunization schedule is two doses vaccine on day 0, 28. |
| Quadrivalent influenza vaccine | BIOLOGICAL | One dose of quadrivalent influenza vaccine: 0.25 ml per dose containing 7.5μg antigen. |
| Trivalent influenza vaccine (contains B/Victoria strain) | BIOLOGICAL | One dose of trivalent influenza vaccine (contains B/Victoria strain): 0.25 ml per dose containing 7.5μg antigen. |
| Trivalent influenza vaccine (contains B/Yamagata strain) | BIOLOGICAL | One dose of trivalent influenza vaccine (contains B/Yamagata strain): 0.25 ml per dose containing 7.5μg antigen. |
Inclusion Criteria: 1. Pregnant women aged 18 to 39 years in good health or medically stable. 2. Gestational age of 20 to 32 weeks, based on last menstrual period, early or late ultrasound dating. 3. The participant was tested negative for HIV, Syphilis, Hepatitis B, Hepatitis C infection according...
Top 8 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 3 | PHASE3 | mRNA Seasonal Flu vaccine, Flu/COVID-19 mRNA combination vaccine |
| Moderna, Inc. | MRNA | 2 | PHASE3 | mRNA-1018-H5, mRNA-1010, Fluarix Trivalent |
| Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | CDTX | 1 | PHASE3 | CD388 |
| Traws Pharma, Inc. | TRAW | 2 | PHASE2 | TRX-100 |
| Sanofi SA Sponsored ADR | SNY | 4 | PHASE1 | H5N8 pandemic influenza vaccine (adjuvanted) |
| Hoffmann-La Roche | RHHBY | 2 | PHASE3 | Baloxavir Marboxil |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD4117, AZD5315 |
| Sinovac Biotech Ltd. | SVA | 1 | PHASE1 | Cell-based Trivalent Split Influenza Virus Vaccine, Egg-based Trivalent Split Influenza Virus Vaccine |
It is an inactivated, split virion influenza vaccine designed to protect against four influenza virus strains. Sinovac Biotech is developing it for influenza and seasonal influenza, and it is given as an injectable dose. Split virion, inactivated vaccines use virus particles that have been disrupted and chemically inactivated so they cannot cause infection.
Sinovac's quadrivalent influenza vaccine is intended for the prevention of influenza and seasonal influenza. Its Phase 3 trials have studied healthy subjects from 6 months of age, including young children aged 6 to 35 months, and pregnant women aged 18 years and older. It is given as a single 0.5 mL dose in the adult and older-child studies.
Sinovac Biotech, Ltd makes the quadrivalent influenza vaccine (split virion), inactivated. Sinovac trades under the ticker SVA. The company has run its Phase 3 program for this vaccine in China and the Philippines.
Sinovac's quadrivalent influenza vaccine (split virion), inactivated is in Phase 3 development. All four of its listed Phase 3 trials are completed, and none are currently active. The program has enrolled 8,237 participants in total across randomized, double-blind, active-controlled studies.
Four completed Phase 3 trials cover the quadrivalent influenza vaccine (split virion), inactivated: NCT07211152 in pregnant women in the Philippines, NCT06049927 and NCT05245552 in healthy subjects aged 6 to 35 months in China, and NCT03859141, which evaluated safety and immunogenicity of the 7.5 μg/0.25 mL formulation in China.
Yes. Sinovac QIV refers to the same quadrivalent influenza vaccine (split virion), inactivated made by Sinovac Biotech. Trial documents also describe it as quadrivalent influenza vaccine (0.25 mL) and as a 0.5 mL dose of Sinovac QIV, reflecting different dose volumes studied across age groups.