Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
2011 to 2012 Trivalent Influenza Vaccine · 1 trial · 1 indication
Solicited Injection Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering
An SAE is defined as any untoward medical occurrence that at any dose (including overdose): Results in death; Is life-threatening; Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability / incapacity; Is a congenital anomaly / birth defect; Is an important medical event.
| Arm | Type | Description |
|---|---|---|
| Group 1: QIV Lot 1 | EXPERIMENTAL | Participants will receive the Quadrivalent Influenza Vaccine (QIV) from Lot 1. |
| Group 2: QIV Lot 2 | EXPERIMENTAL | Participants will receive the Quadrivalent Influenza Vaccine (QIV) from Lot 2. |
| Group 3: QIV Lot 3 | EXPERIMENTAL | Participants will receive the Quadrivalent Influenza Vaccine (QIV) from Lot 3. |
| Group 4: TIV | ACTIVE_COMPARATOR | Participants will receive the Trivalent Influenza Vaccine (TIV). |
| Name | Type | Description |
|---|---|---|
| Quadrivalent Influenza Vaccine (split virion, inactivated) | BIOLOGICAL | 0.5 mL, Intramuscular |
| 2011 to 2012 Trivalent Influenza Vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
Inclusion Criteria: * Aged 9 to 11 years (children), 12 to 17 years (adolescents), or 18 to 60 years (adults) on the day of inclusion * For child/adolescent subjects, informed consent form has been signed and dated by the parent(s) (and subject, if applicable by local regulations), or another legal...
2011 to 2012 Trivalent Influenza Vaccine is an investigational vaccine being studied for the prevention of influenza. It is a trivalent formulation designed to protect against three influenza strains. The vaccine is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
2011 to 2012 Trivalent Influenza Vaccine is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the safety and efficacy of this investigational influenza vaccine.
2011 to 2012 Trivalent Influenza Vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not yet received regulatory approval. The Phase 3 trial has been completed, and the vaccine remains under evaluation for the prevention of influenza.
2011 to 2012 Trivalent Influenza Vaccine was studied in a Phase 3 clinical trial registered as NCT01481454. This completed trial enrolled 1,701 participants aged 9 years and older in Australia and the Philippines. The study was randomized, double-blind, and active-controlled, evaluating the vaccine's safety and immunogenicity.
2011 to 2012 Trivalent Influenza Vaccine is a trivalent vaccine, meaning it targets three influenza strains. The clinical trial NCT01481454 studied a quadrivalent influenza vaccine, which targets four strains. These are different vaccine formulations, though both are being developed for influenza prevention.