Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Cell-based Trivalent Split Influenza Virus Vaccine (cTIV)
Cell-based Trivalent Split Influenza Virus Vaccine · 1 trial · 1 indication
Incidence of adverse reactions from Day 0 to Day 28 after each dose
| Arm | Type | Description |
|---|---|---|
| Investigational Group :Cell-based Trivalent Split Influenza Virus Vaccine (cTIV) | EXPERIMENTAL | Children aged 6-35 months and vaccine-naïve children aged 3-8 years: 2 doses administered 28 days apart. All other participants: 1 single dose |
| Active Comparator Group: Egg-based Trivalent Split Influenza Virus Vaccine (eTIV) | ACTIVE_COMPARATOR | Children aged 6-35 months and vaccine-naïve children aged 3-8 years: 2 doses administered 28 days apart. All other participants: 1 single dose |
| Placebo Group: Placebo | PLACEBO_COMPARATOR | Children aged 6-35 months and vaccine-naïve children aged 3-8 years: 2 doses administered 28 days apart. All other participants: 1 single dose |
| Name | Type | Description |
|---|---|---|
| Cell-based Trivalent Split Influenza Virus Vaccine (cTIV) | BIOLOGICAL | Investigational trivalent split influenza virus vaccine produced in MDCK cells, administered intramuscularly. |
| Egg-based Trivalent Split Influenza Virus Vaccine (eTIV) | BIOLOGICAL | Licensed trivalent split influenza virus vaccine (Anflu) produced in embryonated chicken eggs, administered intramuscularly. |
| Placebo | OTHER | 0.9% normal saline for intramuscular injection. |
Inclusion Criteria: 1. Healthy trial participants aged ≥6 months; Among them, for children aged 3-8 years: * Influenza vaccine-naïve: children who have never received any influenza vaccine (licensed or investigational); * Previously vaccinated: children who have received at least 1 dose o...