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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01659086 | Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccines GSK2654911A and GSK2654909A Administered to Adults 18 to 64 Years of Age | PHASE1 | COMPLETED | 422 | — | — | Aug 22, 2012 | Mar 19, 2014 | Jun 18, 2018 | 4 | United States, Canada |
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Subjects will receive the investigational vaccine GSK2654911A formulation 1 and placebo |
| Group B | EXPERIMENTAL | Subjects will receive the investigational vaccine GSK2654911A formulation 2 and placebo |
| Group C | EXPERIMENTAL | Subjects will receive the investigational vaccine GSK2654911A formulation 3 and placebo |
| Group D | EXPERIMENTAL | Subjects will receive the investigational vaccine GSK2654911A formulation 4 and placebo |
| Group E | EXPERIMENTAL | Subjects will receive the investigational vaccine GSK2654909A and placebo |
| Group F | EXPERIMENTAL | Subjects will receive the investigational vaccine GSK2654911A formulation 5 |
| Group G | EXPERIMENTAL | Subjects will receive the investigational vaccine GSK2654911A formulation 6 |
| Group H | EXPERIMENTAL | Subjects will receive the investigational vaccine GSK2654911A formulation 7 |
| Group I | EXPERIMENTAL | Subjects will receive the investigational vaccine GSK2654911A formulation 8 |
| Group J | EXPERIMENTAL | Subjects will receive the investigational vaccine GSK2654909A |
| Placebo Group | PLACEBO_COMPARATOR | Subjects will receive Placebo |
| Name | Type | Description |
|---|---|---|
| Investigational H9N2 vaccine GSK2654911A | BIOLOGICAL | 2 or 3 doses of GSK2654911A (different formulations) followed by 1 or 0 dose of saline placebo respectively, depending in the treatment group. All doses to be administered intramuscularly (IM) in deltoid region of arm. |
| Investigational H9N2 vaccine GSK2654909A | BIOLOGICAL | 2 or 3 doses of GSK2654909A followed by 1 or 0 dose of saline placebo, respectively (treatment 5). All doses to be administered IM in deltoid region of arm. |
| Placebo | BIOLOGICAL | 1 dose of saline placebo administered intramuscularly (IM) in deltoid region of arm. |
Inclusion Criteria: * Male or female adults from 18 to 64 years of age (inclusive) at time of first study vaccination. * Written informed consent obtained from the subject. * Subjects who the investigator believes can and will comply with the requirements of the protocol. * Healthy subjects as esta...