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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03430089 | Safety of a Single Dose or Two Doses of Shenzhen Quadrivalent Influenza Vaccine | PHASE1 | COMPLETED | 101 | — | — | Feb 22, 2019 | Jun 6, 2019 | Nov 9, 2022 | 1 | China |
Number of participants reporting serious adverse reactions and Grade 3 adverse reactions following a vaccination with Shz QIV
| Arm | Type | Description |
|---|---|---|
| Group 1: 6 to 35 months | EXPERIMENTAL | Shz QIV 0.25 mL, 2 doses |
| Group 2: 3 to 8 years | EXPERIMENTAL | Shz QIV 0.5 mL, 2 doses |
| Group 3: 9 to 17 years | EXPERIMENTAL | Shz QIV 0.5 mL, single dose |
| Group 4: 18 to 60 years | EXPERIMENTAL | Shz QIV 0.5 mL, single dose |
| Group 5: 61 years and older | EXPERIMENTAL | Shz QIV 0.5 mL, single dose |
| Name | Type | Description |
|---|---|---|
| Shz QIV 0.25 mL, 2 doses | BIOLOGICAL | Administered intramuscularly in the anterolateral aspect of the thigh in infants (aged 6 to 12 months) or into the deltoid muscle (participants aged more than 12 months), 28 days apart. |
| Shz QIV 0.5 mL, 2 doses | BIOLOGICAL | Administered intramuscularly into the deltoid muscle, 28 days apart |
| Shz QIV 0.5 mL, single dose | BIOLOGICAL | Administered intramuscularly into the deltoid muscle. |
Inclusion Criteria: * Aged ≥ 6 months on the day of inclusion * For participants aged 6 months through 17 years: Informed consent form has been signed and dated by the parent(s) or another legally acceptable representative, if applicable. Additionally an assent form has been signed and dated by the...