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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01481454 | Study of a Quadrivalent Influenza Vaccine Administered Intramuscularly in Children/Adolescents and Adults | PHASE3 | COMPLETED | 1,701 | — | — | Mar 1, 2012 | Dec 1, 2012 | Mar 29, 2013 | 6 | Australia, Philippines |
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...