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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00979602 | Safety, Immunogenicity, and Relative Efficacy of H1N1 Vaccines in Adults Aged 18 Years and Older | PHASE3 | COMPLETED | 4,048 | — | — | Nov 9, 2009 | Feb 1, 2011 | Mar 21, 2018 | 38 | United States, Canada |
| NCT00976820 | Safety and Immunogenicity of H1N1 Vaccines in Children Aged 6 Months to Less Than 9 Years of Age | PHASE2 | COMPLETED | 323 | — | — | Oct 20, 2009 | Mar 21, 2011 | Dec 12, 2017 | 30 | United States, Canada |
| NCT00985088 | Safety and Immunogenicity of H1N1 Vaccines in Adults Aged 18 Years and Older | PHASE2 | COMPLETED | 1,343 | — | — | Oct 11, 2009 | Dec 16, 2010 | Dec 12, 2017 | 14 | United States, Canada |
| NCT00985673 | Safety and Immunogenicity of H1N1 Vaccine With Trivalent Inactivated Seasonal Influenza Vaccine in Adults | PHASE2 | COMPLETED | 611 | — | — | Oct 1, 2009 | Dec 29, 2010 | Aug 1, 2018 | 7 | United States, Canada |
A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer higher than or equal to (≥)1:40 or at least a 4-fold increase of the pre-vaccination titer of ≥ 1:10. The Flu strain assessed was A/California/7/09 (H1N1)v-like (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance.
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) antibody titer ≥ 1:40 against the tested virus. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
SCF was defined as the fold increase in serum HI 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, in subjects 18-60 years and older and 18-64 years and older, following the CHMP guidance.
The analysis focused on Quantitative Reverse Transcription Polymerase Chain Reaction Assay (RT-qPCR)-confirmed A/California/7/2009 (H1N1)v-like illness (ILI) cases.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer lower than (\<) 10 and a post-vaccination reciprocal HI titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer \< 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer \< 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
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.
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.
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 against the A/California/ virus strain was defined as a subject with H1N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and subjects older than (\>) 60 years.
A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 64 years (y) old and subjects \> 64 years.
A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥ 1:40 and at least a 4-fold increase in pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18 and 60 years of age and older (\>60y).
A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥ 1:40 and at least a 4-fold increase in pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18 and 64 years and older (\>64y).
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) and results were tabulated for subjects between 18 and 60 years and older (\>60y).
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The Flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18 and 64 years and older (\>64y).
SCF was defined as the fold increase in serum HI geometric mean ratio (mean\[log10(POST/PRE)\]) vaccination compared to Day 21. The flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18 and 60 years of age and older (\>60y).
SCF was defined as the fold increase in serum HI geometric mean ratio (mean\[log10(POST/PRE)\]) vaccination compared to Day 21. The flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18 and 64 years of age and older (\>64y).
The A/California vaccine virus-homologous antibody response was measured in subjects having received Flulaval vaccine co-administered with the first dose of Arepanrix vaccine, and in subjects having received two doses of Arepanrix vaccine alone. Titers were expressed as geometric mean antibody titers (GMTs).
| Arm | Type | Description |
|---|---|---|
| GSK2340274A Group | EXPERIMENTAL | Healthy male or female subjects between and including 18 to 60 years of age and older (\>60 years) and between 18 to 64 years of age and older (\>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| GSK2340273A Group | EXPERIMENTAL | Healthy male or female subjects between and including 18 to 60 years of age and older (\>60 years) and between 18 to 64 years of age and older (\>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm. |
| Arepanrix/F1 Group | EXPERIMENTAL | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh \[for children under (\<) 12 months of age\]. The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age). |
| Arepanrix/F2 Group | EXPERIMENTAL | Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age). |
| GSK2340273A/F1 Group | EXPERIMENTAL | Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age). |
| GSK2340273A/F2 Group | EXPERIMENTAL | Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age). |
| GSK2340274A F1_2D Group | EXPERIMENTAL | Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm. |
| GSK2340274A F2_2D Group | EXPERIMENTAL | Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm. |
| GSK2340274A F2_1D Group | EXPERIMENTAL | Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm. |
| GSK2340274A F1_1D Group | EXPERIMENTAL | Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm. |
| GSK2340273A F1_1D Group | EXPERIMENTAL | Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. |
| GSK2340273A F2_2D Group | EXPERIMENTAL | Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm. |
| GSK2340273A F2_1D Group | EXPERIMENTAL | Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm. |
| GSK2340273A F3_2D Group | EXPERIMENTAL | Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm. |
| Flulaval/placebo/unadjuvanted Arepanrix Group | EXPERIMENTAL | subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm. |
| Flulaval/placebo/Arepanrix Group | EXPERIMENTAL | subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm. |
| Flulaval/unadjuvanted Arepanrix/placebo Group | EXPERIMENTAL | subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm. |
| Flulaval/Arepanrix/placebo Group | EXPERIMENTAL | subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm. |
| Unadjuvanted Arepanrix/placebo/Flulaval Group | EXPERIMENTAL | subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm. |
| Arepanrix/placebo/Flulaval Group | EXPERIMENTAL | subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm. |
| Name | Type | Description |
|---|---|---|
| GSK2340274A | BIOLOGICAL | One intramuscular injection |
| GSK2340273A | BIOLOGICAL | One intramuscular injection |
| Saline placebo | BIOLOGICAL | One injection |
| Seasonal trivalent influenza vaccine (TIV) | BIOLOGICAL | Single intramuscular injection |
Inclusion Criteria: * Subjects who the investigator believes can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject. * Male and female adults, \>= 18 years of age at the time of the first vaccination. * Satisfactory baseline medical assessmen...