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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00714285 | Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate in Adults. | PHASE1 | COMPLETED | 420 | — | — | Jul 14, 2008 | Jan 28, 2009 | Jun 8, 2018 | 1 | Czechia |
Antibody titers were expressed as Geometric mean titers (GMTs).The vaccine influenza strains included A/Solomon Islands,A/Wisconsin,B/Malaysia and B/Jiangsu antigens.
| Arm | Type | Description |
|---|---|---|
| Quadrivalent influenza vaccine GSK 2115160A Group 1 | EXPERIMENTAL | Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0 |
| Quadrivalent influenza vaccine GSK 2115160A Group 2 | EXPERIMENTAL | Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0 |
| Trivalent influenza vaccine GSK 2115160A Group 1 | ACTIVE_COMPARATOR | Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0 |
| Trivalent influenza vaccine GSK 2115160A Group 2 | ACTIVE_COMPARATOR | Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0 |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals' quadrivalent influenza vaccine | BIOLOGICAL | Single intramuscular dose on Day 0. |
| GSK Biologicals' trivalent influenza vaccine | BIOLOGICAL | Single intramuscular dose on Day 0. |
Inclusion Criteria: * Healthy subjects as established by medical history and clinical examination before entering into the study. * Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study. * A male or female between, and inclu...