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 6 of 9 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sinovac Biotech Ltd. | SVA | 1 | PHASE3 | Quadrivalent influenza vaccine (split virion), inactivated |
| Moderna, Inc. | MRNA | 1 | PHASE3 | mRNA-1018-H5 |
| 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 |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD4117, AZD5315 |
| GSK plc Sponsored ADR | GSK | 1 | PHASE1 | Flu/COVID-19 mRNA combination vaccine |
It is an inactivated, split virion vaccine designed to protect against seasonal influenza. Because it is quadrivalent, it is formulated to cover four influenza virus strains in a single product. It is administered as an intramuscular injection and is being developed by Sinovac Biotech, Ltd for both seasonal influenza and general influenza prevention.
It is used for the prevention of influenza and seasonal influenza. The vaccine is intended for active immunization of healthy individuals, including young children from 6 months of age and pregnant women, to reduce the risk of illness caused by influenza viruses. It is not a treatment for people who already have influenza.
The vaccine is developed by Sinovac Biotech, Ltd, which trades under the ticker SVA. Sinovac is the sponsor of the clinical development program for this quadrivalent influenza vaccine candidate.
The quadrivalent influenza vaccine (split virion), inactivated is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by the FDA. Four Phase 3 trials have been completed, and one additional Phase 3 trial is currently recruiting participants.
The vaccine has been studied in four Phase 3 trials. Completed trials include NCT06049927 in children aged 6 to 35 months, NCT05245552 in the same age group, and NCT03859141 evaluating the 7.5μg/0.25ml formulation. The ongoing recruiting trial is NCT07211152, which is testing the vaccine in pregnant women in the Philippines.
Yes, Sinovac QIV is another name for the quadrivalent influenza vaccine (split virion), inactivated. The names Quadrivalent influenza vaccine (0.25ml) and Quadrivalent influenza vaccine also refer to the same product. The 0.25 mL designation reflects a lower-dose formulation evaluated in young children, while the 0.5 mL dose is used in other age groups.