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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01999842 | Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine(s) GSK3206641A and GSK3206640A Administered in Adults 18 to 64 Years of Age | PHASE1 | COMPLETED | 424 | — | — | Nov 25, 2013 | Jan 19, 2015 | May 30, 2017 | 8 | United States, Canada |
The following aggregate variables will be calculated for each adjuvanted H7N9 vaccine group: • Seroconversion rates (SCR); • Seroprotection rates (SPR); • Mean Geometric Increase (MGI)
| Arm | Type | Description |
|---|---|---|
| Formulation 1 Group | EXPERIMENTAL | Subjects in this group will receive two doses of GSK3206641A H7N9 vaccine formulation 1 at a 21 day interval |
| Formulation 2 Group | EXPERIMENTAL | Subjects in this group will receive two doses of GSK3206641A H7N9 vaccine formulation 2 at a 21 day interval |
| Formulation 3 Group | EXPERIMENTAL | Subjects in this group will receive two doses of GSK3206641A H7N9 vaccine formulation 3 at a 21 day interval |
| Formulation 4 Group | EXPERIMENTAL | Subjects in this group will receive two doses of GSK3206641A H7N9 vaccine formulation 4 at a 21 day interval |
| Formulation 5 Group | EXPERIMENTAL | Subjects in this group will receive two doses of GSK3206640A H7N9 vaccine formulation 5 at a 21 day interval |
| Placebo Group | PLACEBO_COMPARATOR | Subjects in this group will receive two doses of placebo at a 21 day interval |
| Name | Type | Description |
|---|---|---|
| Investigational H7N9 vaccine GSK3206641A | BIOLOGICAL | One dose of GSK3206641A H7N9 vaccine administered intramuscularly (IM) in the deltoid region of arm at Day 0 and the second dose of GSK3206641A H7N9 vaccine administered IM in the deltoid region of arm at Day 21 |
| Investigational H7N9 vaccine GSK3206640A | BIOLOGICAL | One dose of GSK3206640A H7N9 vaccine administered IM at the deltoid region of arm at Day 0 and the second dose of GSK3206640A H7N9 vaccine administered IM at the deltoid region of arm at Day 21 |
| Placebo | BIOLOGICAL | One dose of placebo administered IM at the deltoid region of arm at Day 0 and the second dose of placebo administered IM at the deltoid region of arm at Day 21 |
Inclusion Criteria: * Male or female adults who are 18 to 64 years of age (inclusive) at the time of first study vaccination. * Written informed consent obtained from subject. * Subjects who the investigator believes can and will comply with the requirements of the protocol . * Healthy subjects as ...