Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Shz QIV, 2 doses · 1 trial · 2 indications
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...
Shz QIV, 2 doses is an investigational quadrivalent influenza vaccine being developed for the prevention of influenza (flu). It is designed to be administered as a two-dose regimen. The vaccine is currently in clinical development and has not been approved by regulatory authorities.
Shz QIV, 2 doses is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the safety of this investigational quadrivalent influenza vaccine.
Shz QIV, 2 doses is in Phase 1 clinical development. It is an investigational quadrivalent influenza vaccine and has not been approved for use. The Phase 1 trial has been completed, and the vaccine remains under investigation for safety and immunogenicity.
Shz QIV, 2 doses has one completed Phase 1 clinical trial registered as NCT03430089, titled 'Safety of a Single Dose or Two Doses of Shenzhen Quadrivalent Influenza Vaccine'. The trial enrolled 101 participants in China and evaluated the safety of the vaccine in healthy volunteers aged 6 months and older.
Yes, Shz QIV, 2 doses refers to the Shenzhen Quadrivalent Influenza Vaccine, as indicated by the clinical trial title. The vaccine is a quadrivalent influenza vaccine being developed by Sanofi, and the trial NCT03430089 assessed its safety when given as a single dose or two doses.