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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01059617 | Safety and Immune Response of Candidate H1N1 Influenza Vaccine GSK2340274A Following Seasonal Influenza Vaccination in Adults | PHASE1 | COMPLETED | 133 | — | — | Feb 9, 2010 | Oct 21, 2011 | Aug 20, 2018 | 3 | United States |
Seroconversion rate (SCR) was defined as the number of subjects who have either a pre-vaccination reciprocal HI titer \< 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Seroprotection rate (SPR) was defined as the number of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus.
Geometric mean fold-rise (GMFR), or seronversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.
Titers were expressed as geometric mean antibody titers (GMTs).
VRR for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0. The cut-off value for microneutralization titers is 1:28.
Seroconversion rate (SCR) was defined as the number of subjects who have either a pre-vaccination reciprocal HI titer \< 1:10 and a post-vaccination reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Seroprotection rate (SPR) was defined as the number of subjects with H1N1 reciprocal HI titers ≥ 1:40 against the tested vaccine virus.
Geometric mean fold-rise (GMFR), or seronversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.
Titers were expressed as geometric mean antibody titers (GMTs).
VRR for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0. The cut-off value for microneutralization titers is 1:28.
| Arm | Type | Description |
|---|---|---|
| Flulaval/Arepanrix Group | EXPERIMENTAL | subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143. |
| Flulaval/Unadjuvanted Arepanrix Group | EXPERIMENTAL | subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143. |
| Placebo/Arepanrix Group | EXPERIMENTAL | subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143. |
| Placebo/Unadjuvanted Arepanrix Group | EXPERIMENTAL | subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143. |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals' FluLaval® | BIOLOGICAL | Intramuscular injection |
| Placebo (saline) | BIOLOGICAL | Intramuscular injection |
| GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340274A | BIOLOGICAL | Intramuscular injections |
| GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340273A | BIOLOGICAL | Intramuscular injections |
Inclusion Criteria: * Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits). * Written informed consent obtained from the subject. * Male or female adults, 19-40 years of age at the time of...