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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01379937 | A Study to Evaluate the Safety and Immunogenicity of a Prime-boost Schedule of GSK Biologicals' Influenza Vaccine in Children | PHASE3 | COMPLETED | 520 | — | — | Jul 28, 2011 | Oct 5, 2012 | Sep 7, 2018 | 2 | Philippines |
Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Turkey/Turkey/01/2005 antigen. The A/Turkey/Turkey/01/2005 (A/TURK) vaccine strain was administered to groups receiving the adjuvanted Influenza vaccine GSK1562902A. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.
Any = occurrence of the symptom regardless of intensity grade. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.
| Arm | Type | Description |
|---|---|---|
| GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group | EXPERIMENTAL | Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
| GSK1562902A Formulation 1 - Havrix / Havrix Jr Group | EXPERIMENTAL | Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
| GSK1562902A Formulation 2 - Havrix / Havrix Jr Group | ACTIVE_COMPARATOR | Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
| Havrix / Havrix Jr Group | ACTIVE_COMPARATOR | Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region. |
| Name | Type | Description |
|---|---|---|
| Influenza vaccine GSK1562902A Formulation 1 | BIOLOGICAL | Intramuscular injection, two doses each in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group |
| Influenza vaccine GSK1562902A Formulation 2 | BIOLOGICAL | Intramuscular injection, one dose each in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group |
| Havrix™ | BIOLOGICAL | Intramuscular injection, one dose in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and two doses each in GSK1562902A Formulation 1 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and Havrix / Havrix Jr Group |
| Havrix™ Junior | BIOLOGICAL | Intramuscular injection, one dose in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and two doses each in GSK1562902A Formulation 1 - Havrix / Havrix Jr Group,GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and Havrix / Havrix Jr Group |
Inclusion Criteria: All subjects must satisfy ALL the following criteria at study entry: * Subjects for whom the investigator believes that the parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol . * A male or female child 3 to 17 yea...