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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06049927 | A Phase III Clinical Trial of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6 to 35 Months | PHASE3 | COMPLETED | 3,300 | — | — | Sep 16, 2023 | May 23, 2024 | Aug 14, 2025 | 5 | China |
| NCT05245552 | A Clinical Trial of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6 to 35 Months | PHASE3 | COMPLETED | 217 | — | — | Aug 8, 2022 | Aug 4, 2023 | May 28, 2024 | 4 | China |
| NCT03859141 | Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine (7.5μg/0.25ml) | PHASE3 | COMPLETED | 2,340 | — | — | Feb 6, 2018 | Nov 2, 2018 | Mar 1, 2019 | 2 | China |
| NCT03853993 | Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine (15µg/0.5ml) | PHASE3 | COMPLETED | 2,380 | — | — | Jan 23, 2018 | Oct 8, 2018 | Feb 27, 2019 | 2 | China |
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 |
|---|---|---|
| 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 |
|---|---|---|
| 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: * Healthy infants aged 6-35 months; * Proven vaccination certificate and birth certificate; * The subjects' guardians can understand and voluntarily sign the informed consent form. Exclusion Criteria: * Received any circulating seasonal influenza vaccine prior to enrollment or...