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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00992511 | Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza (H1N1 Influenza Virus) Vaccine in Adults, Using Two Different Manufacturing Processes | PHASE3 | COMPLETED | 300 | — | — | Oct 14, 2009 | Nov 9, 2010 | Jan 31, 2019 | 4 | Germany |
| NCT00972517 | Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children | PHASE3 | COMPLETED | 245 | — | — | Sep 29, 2009 | Nov 22, 2010 | Jun 26, 2019 | 8 | Germany |
| NCT00975884 | Study to Evaluate Immunogenicity & Safety of an Investigational Influenza Vaccine in Adults | PHASE3 | COMPLETED | 312 | — | — | Sep 14, 2009 | Apr 30, 2010 | Mar 18, 2019 | 5 | France |
| NCT00968526 | Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults | PHASE3 | COMPLETED | 240 | — | — | Sep 8, 2009 | Sep 23, 2010 | Jun 25, 2019 | 1 | Belgium |
| NCT00968539 | Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults | PHASE3 | COMPLETED | 130 | — | — | Sep 8, 2009 | Sep 28, 2010 | Nov 18, 2019 | 1 | Belgium |
| NCT00951041 | Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults | PHASE2 | COMPLETED | 130 | — | — | Aug 11, 2009 | Aug 30, 2010 | Nov 26, 2018 | 3 | Germany |
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...