Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK investigational vaccine GSK2340272A · 6 trials · 1 indication
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:10, that usually is accepted as indicating protection.
Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.
Antibody titers were expressed as Geometric mean titers (GMTs).
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (\<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (\>) 40% in children aged 3 to 17 years.
A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the post-vaccination time point estimate for SPR the point estimate for SPR was greater than (\>) 70% in children aged 3 to 17 years.
GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The CHMP criterion was fulfilled if the point estimate for GMFR was greater than (\>) 2.5 in children aged 3 to 17 years
Seroconversion was defined as: For initially seronegative subjects \[antibody titer below (\<) 1:10 post to vaccination\], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was \> 40% in subjects 18 to 60 years of age or \> 30% for subjects above 60 years of age.
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70% in subjects 18 to 60 of age or \> 60% for subjects above 60 years of age.
Seroconversion was defined as: For initially seronegative subjects \[antibody titer below (\<) 1:10 post to vaccination\], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was \> 40% in subjects 18 to 60 years of age or \> 30% for subjects above 60 years of age.
GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. The criterion was fulfilled if the point estimate for GMFR was \> 2.5 in subjects 18 to 60 years of age or \> 2 for subjects above 60 years of age.
Seroconversion was defined as: For initially seronegative subjects \[antibody titer (below) \< 10 post-vaccination\], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09). This outcome included only subjects who received two doses of the study product and results were tabulated per age stratum. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70% in subjects 18 to 60 of age or \> 60% for subjects above 60 years of age .
Seroconversion was defined as: For initially seronegative subjects \[antibody titer below (\<) 1:10 prior to vaccination\], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).
A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer ≥ 1:40. The flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old. The primary endpoint results consist in those presented for GSK2340272A Group.
Seroconversion (SCR) was defined as follows: for initially seronegative subjects, antibody titer equal to or above (≥) 1:40 after vaccination; for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old. The primary endpoint results consist in those presented for GSK2340272A Group.
GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old. The primary endpoint results consist in those presented for GSK2340272A Group.
| Arm | Type | Description |
|---|---|---|
| GSK2340272A New 1D Group | EXPERIMENTAL | Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the New process-manufactured (New 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0. |
| GSK2340272A New 2D Group | EXPERIMENTAL | Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the New process-manufactured (New 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
| GSK2340272A INI 1D Group | EXPERIMENTAL | Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the Initial process-manufactured (INI 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0. |
| GSK2340272A INI 2D Group | EXPERIMENTAL | Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the Initial process-manufactured (INI 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
| Group A | EXPERIMENTAL | Subjects receiving alternative dose of GSK23440272A vaccine |
| GSK2340272A (D21) GROUP | EXPERIMENTAL | Healthy male or female adults, above 18 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21 (D21). |
| GSK2340272A (M6) GROUP | EXPERIMENTAL | Healthy male or female adults, above 18 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Month 6 (M6). |
| GSK2340272A 2D Group | EXPERIMENTAL | Healthy male or female adults, aged 18 to 60 years (18-60y) and above (\>60y), who received two doses (2D) of GSK2340272A vaccine, one administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and the other one, administered intramuscularly in the deltoid region of the dominant arm at Day 21. |
| GSK2340272A 1D Group | EXPERIMENTAL | Healthy male or female adults, aged 18 to 60 years (18-60y) and above (\>60y), who received a single dose (1D) of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0. |
| GSK2340272A GROUP | EXPERIMENTAL | Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
| GSK2340269A GROUP | EXPERIMENTAL | Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
| Name | Type | Description |
|---|---|---|
| GSK investigational vaccine GSK2340272A | BIOLOGICAL | One intramuscular injection of initial process-manufactured GSK2340272A vaccine |
| GSK investigational vaccine GSK2340269A | BIOLOGICAL | Two intramuscular injections |
Inclusion Criteria: * All subjects must satisfy ALL the following criteria at study entry: * A male or female aged 18 to 60 years of age at the time of the first vaccination. * Subjects who the investigator believes that they can and will comply with the requirements of the protocol. * Written info...
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GSK2340272A is an investigational influenza vaccine developed by GSK plc. It is a vaccine candidate studied for the prevention of influenza, including H1N1 influenza virus. It has been evaluated in Phase 3 clinical trials in healthy adult and pediatric volunteers.
GSK2340272A is being studied for use against influenza, including H1N1 influenza virus. Clinical trials have enrolled healthy volunteers, including adults and children, to evaluate the vaccine's immunogenicity and safety for preventing influenza infection.
GSK2340272A is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the Phase 3 clinical trials evaluating the vaccine candidate in adult and pediatric populations across multiple European countries.
GSK2340272A has been studied in Phase 3 clinical trials. All six of its registered trials are completed, and no trials are currently active. The program enrolled a total of 1,357 participants across its studies.
GSK2340272A has been evaluated in completed Phase 3 trials including NCT00992511 in Germany, NCT00975884 in France, NCT00972517 in children in Germany, and NCT00968539 in Belgium. These trials assessed immunogenicity and safety in healthy volunteers, with enrollment ranging from 130 to 312 participants per study.
GSK2340272A was evaluated in randomized, double-blind, controlled Phase 3 trials. The studies enrolled healthy volunteers aged 3 years and older across Germany, France, and Belgium, and assessed the vaccine's immunogenicity and safety against influenza, including H1N1 influenza virus.