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Candidate Influenza Vaccine GSK1247446A- 2 different formulations

Phase 2

Influenza | Vaccine | Infectious Disease |GSK plc|Trials Updated: Jun 8, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment1,220

FDA Designations

No designations recorded

Candidate Influenza Vaccine GSK1247446A- 2 different formulations clinical trials

Candidate Influenza Vaccine GSK1247446A- 2 different formulations · 1 trial · 1 indication

Phase 2 1
NCT00321373Study to Evaluate an Influenza Vaccine CandidateInfluenza
COMPLETED1,220 Analytics
PHASE2COMPLETED
Study to Evaluate an Influenza Vaccine Candidate
InfluenzaUnlock trial analytics

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.

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.

Interventions

NameTypeDescription
Candidate Influenza Vaccine GSK1247446A - 2 different formulationsBIOLOGICALSingle dose, Intramuscular injection
FluarixTMBIOLOGICALSingle dose, Intramuscular injection
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Eligibility Criteria

Age Range60 Years to 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:FinlandGreece
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Frequently asked questions about Candidate Influenza Vaccine GSK1247446A- 2 different formulations

What is Candidate Influenza Vaccine GSK1247446A used for?

Candidate Influenza Vaccine GSK1247446A is an investigational vaccine being developed for the prevention of influenza. It is intended for use in older adults, with the completed Phase 2 study enrolling participants aged 60 years and older. It is not an approved product and remains in clinical development.

Who is developing Candidate Influenza Vaccine GSK1247446A?

Candidate Influenza Vaccine GSK1247446A is being developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program evaluating this influenza vaccine candidate.

What phase is Candidate Influenza Vaccine GSK1247446A in?

Candidate Influenza Vaccine GSK1247446A is in Phase 2 development. One Phase 2 trial has been completed, and no active trials are currently listed for this candidate. It is an investigational vaccine and has not been approved for any indication.

What clinical trials is Candidate Influenza Vaccine GSK1247446A in?

Candidate Influenza Vaccine GSK1247446A has been studied in one completed Phase 2 trial, NCT00321373, titled Study to Evaluate an Influenza Vaccine Candidate. That trial enrolled 1,220 participants in Finland and Greece, was randomized and active-controlled, and included healthy volunteers aged 60 years and older.