Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Fluarix · 23 trials · 4 indications
The strains assessed were: Flu A/Christchurch/16/2010 H1N1 HI, Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata) ,Flu B/Brisbane/60/2008 Victoria HI. Titers are presented as geometric mean titers (GMTs).
The strains are: Flu A/Christchurch/16/2010 H1N1 HI, Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI,(referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroprotected subject is defined as a subject with serum HI titre ≥ 1:40.
The strains are: Flu A/Christchurch/16/2010 H1N1 HI,(referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroconverted subject is defined as a subject with either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least 4-fold increase in post-vaccination titer.
The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata) Flu B/Brisbane/60/2008 Victoria HI. MGI was defined as the fold increase in serum HI geometric mean titers post-vaccination compared to Day 0.
The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. SPP is defined as the percentage of subjects who had a pre-vaccination titer \< 1:40 and a post-vaccination titer ≥ 1:40.
Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
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 in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
SPP was defined as the number of vaccinated subjects with a pre-vaccination titer \< 1:40 and a post-vaccination titer ≥ 1:40. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/10 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata).
Seroprotection rate (SPR) was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer greater than or equal to (≥) 1:40.
Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains
A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40
A seroconverted subject is a subject with a pre-vaccination serum HI titer \< 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and a fold increase (Day 21/Day 0) ≥ 4
Seroconversion factor, defined as the fold increase in serum HI GMT post-vaccination compared to pre-vaccination (Day 0), is presented for all three vaccine influenza virus strains
Seroprotection power is defined as the number of subject who had a pre-vaccination titer \< 1:40 and a post-vaccination titer ≥ 1:40
Titers were expressed as GMTs. The Pandemrix vaccine strain was A/Cal/7/09.
The Pandemrix vaccine strain was A/Cal/7/09. The cut-off was a titer of 1:10 and this titer was considered as seropositivity.
The Pandemrix vaccine strain was A/Cal/7/09. A subject seroconverted for haemagglutination inhibition (HI) antibodies was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.
Seroconversion Factor (SCF) is defined as the fold increase in serum HI antibody GMTs post-vaccination compared to prevaccination (Day 0). The Pandemrix vaccine strain was A/Cal/7/09.
The Pandemrix vaccine strain was A/Cal/7/09. A seroprotected subject was defined as a subject with a serum HI antibody titer greater than or equal to 1:40.
The cut-off value assessed was ≥ 1:10 and was presented for all three vaccine influenza virus strains
GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine. Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects
Seroconversion is defined as the number of subjects with either a pre-vaccination anti-HA titer \< 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum 4-fold increase at post-vaccination titer. Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects
A seroconverted subject is a subject with a pre-vaccination serum HI titer \< 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and a fold increase (Day 21/Day 0) ≥ 4
Seroconversion factor, defined as the fold increase in serum HI GMT post-vaccination compared to pre-vaccination (Day 0), is presented for all three vaccine influenza virus strains
Solicited local AEs assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.
Duration was expressed as the median number of days the symptom was experienced.
Solicited general AEs assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 40°C. Related: symptom assessed by the investigator as causally related to the study vaccination.
Duration was expressed as the median number of days the symptom was experienced.
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any: any AE regardless of intensity or relationship to vaccination. Grade 3: AE that prevented normal activity. Related: AE considered by the investigator to be causally related to the study vaccination.
GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine.
Rare serious event is defined as any untoward medical event with an occurrence rate of ≥1/300 that: * resulted in death, * was life-threatening, * required hospitalization or prolongation of existing hospitalization, * resulted in disability/incapacity, or * was a congenital anomaly/birth defect in the offspring of a study subject.
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations equal to or above (≥) 0.1 International Units per milliliter (IU/mL), respectively.
The assay cut-off value was ≥ 1.0 IU/mL, as assessed by enzyme-linked immunosorbent assay (ELISA).
Anti-PT, anti-FHA and anti-PRN antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).
The antibody titer cut-off value for the 3 influenza strains assessed (H1N1, H3N2 and B) was ≥ 1:40.
Seroconversion for HI antibodies is defined as: For initially seronegative subjects: post-vaccination antibody titer ≥ 1:40 at Month 1 post-Boostrix® vaccination; For initially seropositive subjects: antibody titer at Month 1≥ 4 fold the pre-vaccination antibody titer.
Duration was defined as number of days with any grade of local symptoms.
Any temperature was defined as axillary temperature ≥38.0 degree centigrade (°C), grade 3 temperature was axillary temperature ≥39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as general symptom that prevented normal activity. Related was general symptom assessed by the investigator as causally related to the study vaccination.
Duration was defined as number of days with any grade of general symptoms.
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was event that prevented normal activities and related was defined as unsolicited AE assessed by the investigator to be causally related to the study vaccination.
MSCs were defined as AEs with a medically-attended visit i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. At least one MSC was defined as at least one MSC experienced. Grade 3 was MSC that prevented normal activities and Related was defined as MSC assessed by the investigator to be causally related to the study vaccination.
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.
Antibody titers were expressed as Geometric mean titers (GMTs) against each of the 3 vaccine strains in greater than or equal to 65 years age groups only. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA). The seropositivity cut-off assay was 1:10. The results for Day 0 and Day 21 are the primary efficacy variables.
Antibody titers were expressed as Geometric mean titers (GMTs). The H1N1 vaccine strains included A/New Caledonia and A/Solomon Islands antigens. A/New Caledonia vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season. A/Solomon Islands vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season.
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28. This outcome only covers results from the adjuvanted groups.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). This outcome only covers results from the adjuvanted groups.
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).
Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), B/Malaysia (B/MAL) strains. Titers were presented as geometric mean titers (GMTs) calculated on subjects with available results, and expressed in haemagglutination-inhibition unit (HIU), e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen. The seropositivity cut-off value of the assay was 10 HIU.
A seroprotected subject was a subject whose antibody titer against each of the influenza strains assessed (A/New Caledonia (A/CAL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL) strains) was equal to or higher than (\>=) the assay seroprotection cut-off value of 40 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen).
Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. A seroconverted subject was a subject who had either a pre-vaccination serum HI antibody titer lower than 10 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen) and a post-vaccination titer higher than or equal to 40 HIU, or a pre-vaccination titer \>= 10 and at least a four-fold increase in post- vaccination titer.
Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. The seroconversion factor (SCF) was defined as a ratio, as the fold increase in serum haemagglutination-inhibition geometric mean titers (GMTs) post-vaccination compared to Day 0 (with GMTs in the above calculation expressed in haemagglutination-inhibition units (HIU) \[e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenza antigen\]).
The frequency was expressed as the geometric mean of influenza-specific CD4 T-cells, expressing at least 2 markers among CD40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α) and Interferon-γ (IFN-γ ) upon in vitro stimulation.
| Arm | Type | Description |
|---|---|---|
| Fluarix/Influsplit Tetra® Adult Group | EXPERIMENTAL | Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm. |
| Fluarix/Influsplit Tetra® Elderly Group | EXPERIMENTAL | Subjects \>60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm. |
| Fluarix/Influsplit 18-60 Years Group | EXPERIMENTAL | Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm. |
| Fluarix/Influsplit > 60 Years Group | EXPERIMENTAL | Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm. |
| Fluarix Adult Group | EXPERIMENTAL | Subjects aged 18 to 60 years received one dose of Fluarix™. |
| Fluarix Elderly Group | EXPERIMENTAL | Subjects aged \> 60 years received one dose of Fluarix™. |
| Placebo-Pandemrix-Fluarix Group | EXPERIMENTAL | Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42. |
| Fluarix-Pandemrix-Placebo Group | EXPERIMENTAL | Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42. |
| Fluarix Dose A Group | EXPERIMENTAL | Subjects were administered 1 or 2 doses\* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age). \* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses. |
| Fluarix Dose B Group | EXPERIMENTAL | Subjects were administered 1 or 2 doses\*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age). \* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses. |
| Fluzone Group | ACTIVE_COMPARATOR | Subjects were administered 1 or 2 doses\* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age). \* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses. |
| FluAS25 Group | EXPERIMENTAL | Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in the current study. |
| Fluarix ≥ 65 years age Group | ACTIVE_COMPARATOR | Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study. |
| Fluarix 18-40 years age Group | ACTIVE_COMPARATOR | Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study. |
| Fluarix Group | EXPERIMENTAL | Subjects in this group received Fluarix™ and will be further stratified by 3 age groups * 1:1 in 6 months to \< 36 months * 1:1 in 3 to \< 5 years * 3:1 in 5 to \< 18 years |
| BOOSTRIX+FLUARIX GROUP | EXPERIMENTAL | Healthy male or female adults, aged between 19 to 64 years of age inclusive and 65 years or older, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively. |
| FLUARIX BOOSTRIX GROUP | EXPERIMENTAL | Healthy male or female adults, aged between 19 to 64 years of age inclusive and 65 years or older, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region. |
| Adjuvanted influenza vaccine GSK576389A Group | EXPERIMENTAL | Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A. |
| Fluarix young Group | ACTIVE_COMPARATOR | Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine. |
| Influenza vaccine GSK576389A formulation 1 Group | EXPERIMENTAL | Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A. |
| Influenza vaccine GSK576389A formulation 2 Group | EXPERIMENTAL | Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A. |
| Influenza vaccine GSK576389A formulation 3 Group | EXPERIMENTAL | Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A. |
| Influenza vaccine GSK576389A formulation 4 Group | EXPERIMENTAL | Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A. |
| Influenza vaccine GSK576389A formulation 5 Group | EXPERIMENTAL | Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A. |
| Influenza vaccine GSK576389A formulation 6 Group | EXPERIMENTAL | Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A. |
| Influenza vaccine GSK576389A formulation 7 Group | EXPERIMENTAL | Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A. |
| Influenza vaccine GSK576389A formulation 8 Group | EXPERIMENTAL | Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A. |
| GSK1247446A 1 Group | EXPERIMENTAL | Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| GSK1247446A 2 Group | EXPERIMENTAL | Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| GSK1247446A 3 Group | EXPERIMENTAL | Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| GSK1247446A 4 Group | EXPERIMENTAL | Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| GSK576389A- 2006/2007 Season - 1 container Group | EXPERIMENTAL | Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container. |
| GSK576389A - 2006/2007 Season - 2 containers Group | EXPERIMENTAL | Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers. |
| Fluarix 2006/2007 Season Group | ACTIVE_COMPARATOR | Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season. |
| GSK576389A - 2007/2008 Season - 1 container Group | EXPERIMENTAL | Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container. |
| GSK576389A - 2007/2008 Season - 2 containers Group | EXPERIMENTAL | Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers. |
| Fluarix 2007/2008 Season Group | ACTIVE_COMPARATOR | Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season. |
| GSK1562902A 1 Group | EXPERIMENTAL | Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. |
| GSK1562902A 2 Group | EXPERIMENTAL | Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. |
| GSK1562902A 3 Group | EXPERIMENTAL | Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in the deltoid region of each arm. |
| GSK1562902A 4 Group | EXPERIMENTAL | Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in the deltoid region of each arm. |
| GSK1247446A Formulation 1 Group | EXPERIMENTAL | Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| GSK1247446A Formulation 2 Group | EXPERIMENTAL | Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| Fluarix 18-40 Y Group | EXPERIMENTAL | Subjects (aged 18-40 years \[Y\]) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. |
| Fluarix ≥65 Y Group | EXPERIMENTAL | Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. |
| Fluarix-AS25 Group | EXPERIMENTAL | Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS25, administered intramuscularly in the deltoid region of the non-dominant arm. |
| Fluarix-AS50 Group | EXPERIMENTAL | Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS50, administered intramuscularly in the deltoid region of the non-dominant arm. |
| Fluarix- AS01B Group | EXPERIMENTAL | Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01B, administered intramuscularly in the deltoid region of the non-dominant arm. |
| Fluarix- AS01E Group | EXPERIMENTAL | Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01E, administered intramuscularly in the deltoid region of the non-dominant arm. |
| Name | Type | Description |
|---|---|---|
| Fluarix/Influsplit Tetra® (2013-2014 season) | BIOLOGICAL | 1 dose administered intramuscularly in the deltoid region of non-dominant arm |
| Fluarix/Influsplit SSW® (2013-2014 season) | BIOLOGICAL | 1 dose administered intramuscularly (or deeply subcutaneously) in the deltoid region of the non-dominant arm |
| Fluarix/Influsplit SSW 2012-2013 | BIOLOGICAL | 1 dose administered intramuscularly (or deeply subcutaneously) in the deltoid region of the non-dominant arm |
| Fluarix™/Influsplit SSW® | BIOLOGICAL | Single intramuscular dose on Day 0 |
| Pandemrix (GSK investigational influenza GSK2340272A vaccine) | BIOLOGICAL | 2 doses intramuscular injections |
| Fluarix™ | BIOLOGICAL | 1 dose intramuscular injection |
| Placebo | BIOLOGICAL | 1 dose intramuscular injection |
| Fluarix | BIOLOGICAL | One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection. Two different doses are tested. |
| Fluzone | BIOLOGICAL | One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection. |
| GSK Biologicals Influenza Vaccine GSK576389A | BIOLOGICAL | Single dose, Intramuscular injection |
| Fluarix™/Influsplit SSW® 2007/2008 | BIOLOGICAL | - |
| Fluarix® | BIOLOGICAL | GSK Biologicals' inactivated influenza split virus vaccine. |
| Boostrix® | BIOLOGICAL | GSK Biologicals' tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, containing 0.3 mg aluminum. |
| GSK Bio's Influenza Vaccine GSK576389A | BIOLOGICAL | Single dose, Intramuscular injection |
| GlaxoSmithKline Biologicals' influenza vaccine GSK576389A | BIOLOGICAL | Single dose, Intramuscular injection, 8 different formulations were tested (one per group) |
| Influenza Vaccine GSK1247446A - 4 different formulations | BIOLOGICAL | Single dose, Intramuscular injection |
| GSK Bio's influenza vaccine GSK576389A [NH 2006/07 season] | BIOLOGICAL | Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2006-2007 influenza season. |
| GSK Bio's influenza vaccine GSK576389A [NH 2007/08 season] | BIOLOGICAL | Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2007-2008 influenza season. |
| Fluarix [NH 2006/07 season] | BIOLOGICAL | Single dose, intramuscular injection, Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season. |
| Fluarix [NH 2007/08 season] | BIOLOGICAL | Single dose, intramuscular injection, Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season. |
| Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not) | BIOLOGICAL | intramuscular injection |
| Fluarix and adjuvanted influenza vaccine | BIOLOGICAL | - |
| GSK1247446A | BIOLOGICAL | Low-dose GlaxoSmithKline Biologicals' GSK1247446A influenza vaccine |
| adjuvanted influenza vaccine | BIOLOGICAL | - |
| Fluarix-AS25 | BIOLOGICAL | 1 dose administered intramuscularly into the deltoid region of the non-dominant arm |
| Fluarix-AS50 | BIOLOGICAL | 1 dose administered intramuscularly into the deltoid region of the non-dominant arm |
| Fluarix-AS01B | BIOLOGICAL | 1 dose administered intramuscularly into the deltoid region of the non-dominant arm |
| Fluarix-AS01E | BIOLOGICAL | 1 dose administered intramuscularly into the deltoid region of the non-dominant arm |
Inclusion Criteria: * Subjects who the investigator believes can and will comply with the requirements of the protocol. * A male or female aged 18 years or above at the time of vaccination. * Written informed consent obtained from the subject. * Healthy subjects or subjects with well-controlled chr...
Fluarix is an investigational vaccine being studied for the prevention of influenza and acellular pertussis. It is developed by GSK plc (GSK) and is currently in Phase 3 clinical development. Fluarix is being evaluated in controlled clinical trials for its immunogenicity and safety in adult populations.
Fluarix is developed by GSK plc, a biopharma company traded under the ticker GSK. The vaccine is currently in Phase 3 clinical development for influenza and acellular pertussis indications. GSK has conducted multiple clinical trials to evaluate the vaccine's safety and immunogenicity.
Fluarix is in Phase 3 clinical development. It is an investigational vaccine being studied for influenza and acellular pertussis. As of the latest data, Fluarix is not approved and remains under clinical investigation. GSK plc is the developer of this vaccine candidate.
Fluarix has been studied in 22 completed clinical trials with a total enrollment of 18,517 participants. Key trials include NCT00385255, a Phase 3 study evaluating coadministration with Boostrix in adults, and NCT00377585, a Phase 2 study of adjuvanted influenza vaccine. All trials are completed.
No, Fluarix is not the same as Boostrix. Fluarix is an influenza vaccine, while Boostrix is a Tdap vaccine for tetanus, diphtheria, and acellular pertussis. They are separate vaccines developed by GSK, and a clinical trial (NCT00385255) studied their coadministration in adults.