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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00988143 | A Study of Influenza Virus Vaccines in Children and Adults | PHASE2 | COMPLETED | 600 | — | — | Oct 1, 2009 | Mar 1, 2010 | Dec 12, 2013 | 4 | United States |
Solicited injection site reactions (6-23 Months): Tenderness, Redness and Swelling; Solicited systemic reactions: Fever, Abnormal crying, Drowsiness, Loss of appetite, Vomiting and Irritability Grade 3 Tenderness: cries when injected limb is moved; Redness and Swelling: ≥5 cm; Fever: \>103.1°F; Abnormal crying: \>3 hours; Drowsiness: Sleeping most of the time; Loss of appetite: refuses ≥3 feeds/meals; Vomiting: ≥6 episodes/24 hours; Irritability: inconsolable. (24-59 Months): Pain, Redness and Swelling; Fever, Headache, Malaise and Myalgia. Grade 3: Pain, Incapacitating; Redness and Swelling: ≥5 cm; Fever: \>102.1°F, Headache, Malaise and Myalgia: Significant, prevents daily activity. (Adults): Pain, Redness, Induration, and Ecchymosis; Fever, Headache, Malaise, Myalgia and Shivering. Grade 3: Pain: significant, prevents daily activities; Redness, Swelling, Induration and Ecchymosis: \>10 cm; Fever \>102.1°F; Headache, Malaise, Myalgia \& Shivering: Significant, prevents daily activity.
Immunogenicity outcomes were assessed in serum samples by Hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10.
Immunogenicity outcomes were assessed in serum samples by Hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10.
| Arm | Type | Description |
|---|---|---|
| Study Group 1 | EXPERIMENTAL | Participants will receive the 2009-2010 Trivalent Influenza Vaccine (TIV) (Pediatric dose have no preservatives) |
| Study Group 2 | ACTIVE_COMPARATOR | Participants will receive the 2008-2009 Trivalent Influenza Vaccine (TIV) |
| Study Group 3 | ACTIVE_COMPARATOR | Participants will receive the Quadrivalent Influenza Vaccine (QIV) |
| Name | Type | Description |
|---|---|---|
| 2009-2010 Trivalent Influenza Virus Vaccine | BIOLOGICAL | 0.25 mL, Intramuscular (participants at 6 to 35 months of age - Pediatric Dose); Others 0.5 mL, Intramuscular. |
| 2008-2009 Trivalent Influenza Virus Vaccine | BIOLOGICAL | 0.25 mL, Intramuscular; 0.5 mL, Intramuscular. |
| Quadrivalent Influenza Virus Vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
Inclusion Criteria : * Subject is ≥ 6 months to \< 5 years of age or 18 years of age or older on the day of inclusion. * Parent/legal guardian (if the subject is ≥ 6 months to \< 5 years of age) or adult subject (if 18 years of age or older) is willing and able to attend scheduled visits and to com...