Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK Biologicals' FluLaval · 1 trial · 1 indication
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...
GSK Biologicals' FluLaval is used for influenza, a viral infection of the respiratory tract. It is an investigational vaccine being developed to prevent seasonal influenza. The drug is currently in Phase 1 clinical development, meaning it is still being tested for safety and immune response in humans and is not yet approved for public use.
GSK Biologicals' FluLaval is developed by GSK plc, a global biopharmaceutical company. GSK plc is the developer and sponsor of the clinical trials for this influenza vaccine candidate. The company is conducting research to evaluate the safety and immunogenicity of the vaccine in adult populations.
GSK Biologicals' FluLaval is in Phase 1 clinical development. This is the earliest stage of human testing, focused on assessing the vaccine's safety, tolerability, and immune response. It is an investigational product and has not been approved by regulatory authorities. The Phase 1 trial has been completed.
GSK Biologicals' FluLaval has one completed Phase 1 clinical trial, identified as NCT01059617. This trial, titled 'Safety and Immune Response of Candidate H1N1 Influenza Vaccine GSK2340274A Following Seasonal Influenza Vaccination in Adults,' enrolled 133 participants in the United States. The study was randomized, double-blind, and controlled, and included healthy volunteers aged 19 years and older.
Yes, GSK Biologicals' FluLaval is also known as GSK2340274A. The clinical trial NCT01059617 refers to the candidate vaccine as GSK2340274A, which is the same product as FluLaval. This alternative name is used in the context of the Phase 1 study evaluating its safety and immune response in adults.