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Fluarix TM

Phase 2

Influenza | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Jun 8, 2018

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials2
Total Enrollment4,344
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00321373Study to Evaluate an Influenza Vaccine CandidatePHASE2 COMPLETED 1,220May 11, 2006Jul 18, 2006Jun 8, 201817 Finland, Greece
NCT00321763Study to Demonstrate the Lot-to-lot Consistency and to Evaluate the Safety of an Adjuvanted Influenza Vaccine CandidatePHASE2 COMPLETED 3,124Apr 27, 2006Jul 7, 2006Jun 8, 201846 Estonia, France +5
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Study Endpoints
Primary Endpoints
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus
At Days 0 and 21 post-vaccination

Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia, A/New York and B/Malaysia. The reference seropositivity cut-off value was ≥ 1:10.

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

Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/New York and B/Malaysia. The seropositivity cut-off assay was 1:10. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.

Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
At Day 21

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 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.

Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
At Days 0 and 21

A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.

Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
At Day 21

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 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.

Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
During the 7-day (Days 0-6) post vaccination period

Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms were assessed by the investigator as being related to study vaccination.

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
During the 7-day (Days 0-6) post vaccination period

Assessed solicited general symptoms were arthralgia, fatigue, fever \[oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, muscle aches and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.

Number of Subjects With New Onset of Chronic Diseases (NOCDs).
From Day 0 to Day 180

NOCDs include conditions such as diabetes, autoimmune disease, asthma, allergies etc. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the NOCDs.

Number of Subjects With Medically Significant Conditions (MSCs).
From Day 0 to Day 180

MSCs were defined as conditions prompting emergency room visits or physician visits that were not related to common diseases or routine visits. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the MSCs.

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
During the 30-day (Days 0-29) post-vaccination period

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 unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the AEs.

Number of Subjects With Any and Related Serious Adverse Events (SAEs).
During the entire study period (Days 0-180)

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 = any SAE regardless of intensity or relationship to vaccination. Related (REL) = SAE assessed by the investigator as related to the vaccination.

Secondary Endpoints
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus
At Day 180 post-vaccination.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
During the 7-day (Days 0-6) follow-up period after vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
During the 7-day (Days 0-6) follow up period after vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
GSK1247446A-AS03 GroupEXPERIMENTALSubjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
GSK1247446A GroupEXPERIMENTALSubjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Fluarix GroupACTIVE_COMPARATORSubjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
GSK1247446A Lot 1 GroupEXPERIMENTALSubjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
GSK1247446A Lot 2 GroupEXPERIMENTALSubjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
GSK1247446A Lot 3 GroupEXPERIMENTALSubjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
GSK1247446A Pooled GroupEXPERIMENTALSubjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
Interventions
NameTypeDescription
Candidate Influenza Vaccine GSK1247446A - 2 different formulationsBIOLOGICALSingle dose, Intramuscular injection
FluarixTMBIOLOGICALSingle dose, Intramuscular injection
Candidate Influenza Vaccine GSK1247446A - 3 different formulationsBIOLOGICALSingle dose, Intramuscular injection
Fluarix TMBIOLOGICALSingle dose, Intramuscular injection
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Eligibility Criteria
Age Range60 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites17

Inclusion criteria: * A male or female age 60 years or older at the time of the vaccination. * Subjects who the investigator believes can and will comply with the requirements of the protocol * Written informed consent obtained from the subject. * Free of an acute aggravation of the health status a...

Countries:FinlandGreeceEstoniaFranceGermanyNorwayRussiaUnited Kingdom
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