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...
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| GSK plc Sponsored ADR | GSK | 3 | PHASE3 | mRNA Seasonal Flu vaccine, Flu/COVID-19 mRNA combination vaccine |
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| Moderna, Inc. | MRNA | 2 | PHASE3 | mRNA-1018-H5, mRNA-1010, Fluarix Trivalent |
| Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | CDTX | 1 | PHASE3 | CD388 |
| Traws Pharma, Inc. | TRAW | 2 | PHASE2 | TRX-100 |
| Sanofi SA Sponsored ADR | SNY | 4 | PHASE1 | H5N8 pandemic influenza vaccine (adjuvanted) |
| Hoffmann-La Roche | RHHBY | 2 | PHASE3 | Baloxavir Marboxil |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD4117, AZD5315 |
GSK Biologicals' FluLaval is an investigational monoclonal antibody being developed by GSK plc for influenza. It is in Phase 1 clinical development and has been studied in a completed Phase 1 trial. It is not an approved product.
GSK Biologicals' FluLaval is being developed for influenza, an infectious disease. The completed Phase 1 trial evaluated a candidate H1N1 influenza vaccine following seasonal influenza vaccination in adults. It remains investigational and is not approved for use.
GSK Biologicals' FluLaval is developed by GSK plc, which trades under the ticker GSK. GSK Biologicals is the developer name associated with this asset.
GSK Biologicals' FluLaval is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. It is investigational and has not been approved by the FDA.
GSK Biologicals' FluLaval has been studied in one completed Phase 1 trial, NCT01059617, titled Safety and Immune Response of Candidate H1N1 Influenza Vaccine GSK2340274A Following Seasonal Influenza Vaccination in Adults. The trial enrolled 133 participants in the United States.
Yes, GSK Biologicals' FluLaval and GSK Biologicals' FluLaval® refer to the same asset. The registered trademark symbol is part of the name used by the developer, GSK plc.