Recent Updates
Recently added Catalysts

Fluarix

Phase 3

Influenza | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Jun 14, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials22
Total Enrollment18,517
FDA Designations
No designations recorded
Clinical Trials (22)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01878812Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine, Fluarix/Influsplit Tetra® (2013/2014 Season), in Adults 18 Years of Age and OlderPHASE3 COMPLETED 117Jul 11, 2013Aug 5, 2013Sep 7, 20184 Germany
NCT01884519Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine, Fluarix®/Influsplit SSW® (2013/2014 Season), in Adults 18 Years of Age and OlderPHASE3 COMPLETED 120Jul 1, 2013Aug 2, 2013Sep 7, 20184 Germany
NCT01607112A Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix/Influsplit SSW 2012/2013 in People Aged 18 Years and AbovePHASE3 COMPLETED 119Jul 10, 2012Jul 31, 2012Sep 7, 20184 Germany
NCT01144299A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in AdultsPHASE3 COMPLETED 114Jun 17, 2010Jul 10, 2010Sep 24, 20186 Germany
NCT00971425Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1)PHASE3 COMPLETED 145Sep 8, 2009Oct 8, 2010Aug 17, 20186 Germany
NCT00920374A Study for Evaluation of Immunogenicity and Reactogenicity of FluarixTM / Influsplit SSW® 2009/2010 in AdultsPHASE3 COMPLETED 118Jun 16, 2009Jul 8, 2009Sep 21, 20185 Germany
NCT00764790Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine Versus a Licensed Comparator in ChildrenPHASE3 COMPLETED 3,317Oct 1, 2008Jun 1, 2009Jul 31, 201869 United States, Hong Kong +3
NCT00706563A Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix™ / Influsplit SSW® 2008/2009 in AdultsPHASE3 COMPLETED 120Jul 7, 2008Jul 30, 2008Aug 17, 20185 Germany
NCT00529516Evaluate Safety & Immunogenicity of GSK Bio's Influenza Vaccine GSK576389A After Repeated Vaccination in Elderly AdultsPHASE3 COMPLETED 1,252Oct 15, 2007Jun 4, 2008Jun 8, 201829 United States, Belgium +2
NCT00476307Immunogenicity and Reactogenicity of Fluarix™ (Influsplit SSW®) 2007/2008 in People 18 Years Old or AbovePHASE3 COMPLETED 120Jun 1, 2007Jul 1, 2007Nov 4, 20163 Germany
NCT00383123Study Comparing the Immune Response and Safety of Fluarix and Fluzone Influenza Vaccines in ChildrenPHASE3 COMPLETED 3,327Nov 2, 2006Oct 19, 2007Jun 8, 201840 United States
NCT00345904Study to Evaluate the Safety and Immunogenicity of Fluarix™ 2006/2007 in Adults Aged 18 Years or AbovePHASE3 COMPLETED 120Jul 1, 2006Aug 1, 2006Sep 28, 20164 Germany
NCT00538213Evaluation of Safety and Immunogenicity of GSK Bio's Influenza Vaccine GSK576389A After Repeated Vaccination in Elderly AdultsPHASE2 COMPLETED 133Oct 15, 2007Nov 28, 2007Jun 8, 20181 Belgium
NCT00540592Immunogenicity and Safety Study to Evaluate Different Formulations of GSK Biologicals' Influenza Vaccine GSK576389APHASE2 COMPLETED 2,007Oct 8, 2007Jun 10, 2008Jun 8, 201830 Germany, Netherlands +2
NCT00540228Study to Evaluate an Influenza Vaccine CandidatePHASE2 COMPLETED 1,006Oct 5, 2007May 8, 2008Jun 14, 201915 France, Germany +1
NCT00532298Non-Inferiority of Various GSK Bio's Influenza Vaccine Presentations in Adults Aged 65 Years and OverPHASE2 COMPLETED 1,596Sep 20, 2007Nov 2, 2007Jun 8, 20186 Denmark, Estonia +1
NCT00397215Evaluate Safety & Immunogenicity of a Pandemic Influenza Vaccine (GSK1562902A) in Adults Over 60 Years of AgePHASE2 COMPLETED 437Nov 17, 2006Sep 14, 2009Jun 10, 201912 Belgium, Italy
NCT00386113Study to Evaluate Reactogenicity and Immunogenicity of Revaccination With Adjuvanted Influenza Vaccine in ElderlyPHASE2 COMPLETED 74Oct 16, 2006Nov 14, 2006Feb 26, 20181 Belgium
NCT00374842Study to Evaluate the Immunogenicity and Safety of 2 Formulations of GlaxoSmithKline (GSK) Biologicals' GSK1247446A Low Dose Influenza Vaccine CandidatePHASE2 COMPLETED 300Oct 3, 2006Nov 30, 2006Jun 8, 20181 Belgium
NCT00386698Study to Evaluate Reactogenicity and Immunogenicity of Revaccination With Adjuvanted Influenza Vaccine in Elderly AdultsPHASE2 COMPLETED 200Oct 1, 2006Dec 1, 2006Oct 7, 20161 Belgium
NCT00377585Demonstrate the Superiority of the Immune Response of Adjuvanted Influenza Vaccine Induced in an Adult PopulationPHASE2 COMPLETED 3,350Sep 22, 2006Jan 30, 2007Apr 24, 201730 United States, Belgium +2
NCT00318149Safety Study of Four Candidate Influenza Vaccines to Prevent Influenza Disease in the Elderly PopulationPHASE2 COMPLETED 425Oct 10, 2005May 14, 2006Aug 8, 20181 Belgium
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Anti-HI Antibody Titers Against 4 Strains of Influenza Disease
At Days 0 and 21

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).

Number of Seroprotected Subjects Against 4 Strains of Influenza Disease
At Day 21

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.

Number of Seroconverted Subjects Against 4 Strains of Influenza Disease
At Day 21

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.

Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease
At Day 21

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.

Seroprotection Powers (SPP) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease
During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)

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.

Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains
At Day 0 and Day 21

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).

Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the Three Vaccine Influenza Strains.
At Day 0 and Day 21

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).

Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.
At Day 21

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).

Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.
At Day 21

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).

Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains Above the Cut-off Value.
At Day 21

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).

Humoral Immune Response in Terms of Haemagglutination (HA) Antibody Titers Against Each of the Three Vaccine Influenza Strains
At Day 0 and Day 21

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).

Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.
At Day 0 and Day 21

Seroprotection rate (SPR) was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer greater than or equal to (≥) 1:40.

Hemagglutination Inhibition (HI) Antibody Titer
Day 0 and Day 21

Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains

Number of Seroprotected Subjects
Day 0 and Day 21

A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40

Number of Seroconverted Subjects
Day 21

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
Day 21

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
Day 21

Seroprotection power is defined as the number of subject who had a pre-vaccination titer \< 1:40 and a post-vaccination titer ≥ 1:40

Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain
At Day 42

Titers were expressed as GMTs. The Pandemrix vaccine strain was A/Cal/7/09.

Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain
At Day 42

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.

Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain
At Day 42

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 for Antibodies Against Pandemrix Vaccine Strain
At Day 42

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.

Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain
At Day 42

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.

Number of Subjects With HI Antibody Titer Above the Cut-off Value
Day 0 and Day 21

The cut-off value assessed was ≥ 1:10 and was presented for all three vaccine influenza virus strains

Geometric Mean Titer (GMT) of Serum Anti-hemagglutinin (HA) Antibodies Against Each of the Influenza Vaccine Strains
Day 0 (PRE), Day 28 or Day 56 (POST)

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

Number of Subjects Who Seroconverted
Day 28 or Day 56

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

Number of Serconverted Subjects
At Day 21

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

Serconversion Factor
At Day 21

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

Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
During a 7-day follow-up period after vaccination

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 of Solicited Local Adverse Events
During a 7-day follow-up period after vaccination

Duration was expressed as the median number of days the symptom was experienced.

Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs)
During a 7-day follow-up period after vaccination

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 of Solicited General Adverse Events
During a 7-day follow-up period after vaccination

Duration was expressed as the median number of days the symptom was experienced.

Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
During a 21-day follow-up period after vaccination

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.

Immune response 21 days post vaccination
Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies
21 or 28 days after last vaccine dose

GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine.

Number of Subjects Reporting Rare Serious Events
Up to 6 months after vaccination

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.

to evaluate the humoral immune response in terms of anti-Haemmagglutinin antibodies 21 days post-vaccination
Duration of Solicited Local AEs
Day 0-6

Duration was defined as number of days with any grade of local symptoms.

Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Day 0-6

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 of Solicited General AEs
Day 0-6

Duration was defined as number of days with any grade of general symptoms.

Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
Day 0-20

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.

Number of Subjects Reporting at Least One, Grade 3 and Related Medically Significant Conditions (MSCs)
Day 0-20

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.

Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Day 0-20

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.

Haemagglutination Inhibition (HI) Antibody Titers
At Day 21

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 for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
At Days 0, 21 and 180

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.

Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain
At Days 0 and 21

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 for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
At Days 0, 21 and 42

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.

Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease.
At Days 21 and 42

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).

Number of Seroprotected Subjects Against 2 Strains of Influenza Disease
At Days 0, 21 and 42

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).

Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
At Days 0 and 42

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.

Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.
At Days 21 and 42

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).

Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.
At Day 42

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.

Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
At Month 12

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).

Evaluation of the safety and reactogenicity of repeated vaccination with adjuvanted influenza vaccine, during 21 days following administration of the vaccine.
Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed.
At Day 0 and at Day 21.

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.

Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed.
At Day 0 and at Day 21.

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).

Number of Seroconverted Subjects Against Each of the 3 Influenza Strains Assessed
At Day 21.

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.

Seroconversion Factor Against Each of the 3 Influenza Strains Assessed.
At Day 21.

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) \[e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenza antigen\]).

Evaluation of the safety and reactogenicity of repeated vaccination with adjuvanted influenza vaccine during the 21 days following administration of the vaccine
To demonstrate that the immune response induced by the adjuvanted influenza vaccine in the elderly is superior to that induced by Fluarix, for each vaccine strain
Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T-cells Expressing at Least 2 Markers
At Day 21

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.

Secondary Endpoints
Number of Subjects With Solicited Local Symptoms
During a 21-day follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)
Number of Days of Solicited Local Symptoms
During the entire study period (Days 0 to 21)
Number of Subjects With Solicited General Symptoms
During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Fluarix/Influsplit Tetra® Adult GroupEXPERIMENTALSubjects 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 GroupEXPERIMENTALSubjects \>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 GroupEXPERIMENTALSubjects 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 GroupEXPERIMENTALSubjects 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 GroupEXPERIMENTALSubjects aged 18 to 60 years received one dose of Fluarix™.
Fluarix Elderly GroupEXPERIMENTALSubjects aged \> 60 years received one dose of Fluarix™.
Placebo-Pandemrix-Fluarix GroupEXPERIMENTALSubjects 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 GroupEXPERIMENTALSubjects 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 GroupEXPERIMENTALSubjects 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 GroupEXPERIMENTALSubjects 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 GroupACTIVE_COMPARATORSubjects 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 GroupEXPERIMENTALSubjects 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 GroupACTIVE_COMPARATORSubjects 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 GroupACTIVE_COMPARATORSubjects 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 GroupEXPERIMENTALSubjects 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
Adjuvanted influenza vaccine GSK576389A GroupEXPERIMENTALSubjects 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 GroupACTIVE_COMPARATORSubjects 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 GroupEXPERIMENTALSubjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
Influenza vaccine GSK576389A formulation 2 GroupEXPERIMENTALSubjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
Influenza vaccine GSK576389A formulation 3 GroupEXPERIMENTALSubjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
Influenza vaccine GSK576389A formulation 4 GroupEXPERIMENTALSubjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
Influenza vaccine GSK576389A formulation 5 GroupEXPERIMENTALSubjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
Influenza vaccine GSK576389A formulation 6 GroupEXPERIMENTALSubjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
Influenza vaccine GSK576389A formulation 7 GroupEXPERIMENTALSubjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
Influenza vaccine GSK576389A formulation 8 GroupEXPERIMENTALSubjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
GSK1247446A 1 GroupEXPERIMENTALSubjects 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 GroupEXPERIMENTALSubjects 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 GroupEXPERIMENTALSubjects 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 GroupEXPERIMENTALSubjects 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 GroupEXPERIMENTALSubjects 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 GroupEXPERIMENTALSubjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
Fluarix 2006/2007 Season GroupACTIVE_COMPARATORSubjects 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 GroupEXPERIMENTALSubjects 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 GroupEXPERIMENTALSubjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
Fluarix 2007/2008 Season GroupACTIVE_COMPARATORSubjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
GSK1562902A 1 GroupEXPERIMENTALSubjects 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 GroupEXPERIMENTALSubjects 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 GroupEXPERIMENTALSubjects 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 GroupEXPERIMENTALSubjects 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 GroupEXPERIMENTALSubjects 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 GroupEXPERIMENTALSubjects 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 GroupEXPERIMENTALSubjects (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 GroupEXPERIMENTALSubjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
Fluarix-AS25 GroupEXPERIMENTALSubjects (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 GroupEXPERIMENTALSubjects (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 GroupEXPERIMENTALSubjects (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 GroupEXPERIMENTALSubjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01E, administered intramuscularly in the deltoid region of the non-dominant arm.
Interventions
NameTypeDescription
Fluarix/Influsplit Tetra® (2013-2014 season)BIOLOGICAL1 dose administered intramuscularly in the deltoid region of non-dominant arm
Fluarix/Influsplit SSW® (2013-2014 season)BIOLOGICAL1 dose administered intramuscularly (or deeply subcutaneously) in the deltoid region of the non-dominant arm
Fluarix/Influsplit SSW 2012-2013BIOLOGICAL1 dose administered intramuscularly (or deeply subcutaneously) in the deltoid region of the non-dominant arm
Fluarix™/Influsplit SSW®BIOLOGICALSingle intramuscular dose on Day 0
Pandemrix (GSK investigational influenza GSK2340272A vaccine)BIOLOGICAL2 doses intramuscular injections
Fluarix™BIOLOGICAL1 dose intramuscular injection
PlaceboBIOLOGICAL1 dose intramuscular injection
FluarixBIOLOGICALOne (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection. Two different doses are tested.
FluzoneBIOLOGICALOne (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection.
GSK Biologicals Influenza Vaccine GSK576389ABIOLOGICALSingle dose, Intramuscular injection
Fluarix™/Influsplit SSW® 2007/2008BIOLOGICAL -
GSK Bio's Influenza Vaccine GSK576389ABIOLOGICALSingle dose, Intramuscular injection
GlaxoSmithKline Biologicals' influenza vaccine GSK576389ABIOLOGICALSingle dose, Intramuscular injection, 8 different formulations were tested (one per group)
Influenza Vaccine GSK1247446A - 4 different formulationsBIOLOGICALSingle dose, Intramuscular injection
GSK Bio's influenza vaccine GSK576389A [NH 2006/07 season]BIOLOGICALSingle 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]BIOLOGICALSingle dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
Fluarix [NH 2006/07 season]BIOLOGICALSingle dose, intramuscular injection, Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
Fluarix [NH 2007/08 season]BIOLOGICALSingle dose, intramuscular injection, Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not)BIOLOGICALintramuscular injection
Fluarix and adjuvanted influenza vaccineBIOLOGICAL -
GSK1247446ABIOLOGICALLow-dose GlaxoSmithKline Biologicals' GSK1247446A influenza vaccine
adjuvanted influenza vaccineBIOLOGICAL -
Fluarix-AS25BIOLOGICAL1 dose administered intramuscularly into the deltoid region of the non-dominant arm
Fluarix-AS50BIOLOGICAL1 dose administered intramuscularly into the deltoid region of the non-dominant arm
Fluarix-AS01BBIOLOGICAL1 dose administered intramuscularly into the deltoid region of the non-dominant arm
Fluarix-AS01EBIOLOGICAL1 dose administered intramuscularly into the deltoid region of the non-dominant arm
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites4

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...

Countries:GermanyUnited StatesHong KongMexicoTaiwanThailandBelgiumNorwayNetherlandsSwedenUnited KingdomFranceSpainDenmarkEstoniaItaly
Unlock Eligibility Criteria