Study to Evaluate the Immunogenicity and Safety of 2 Formulations of GlaxoSmithKline (GSK) Biologicals' GSK1247446A Low Dose Influenza Vaccine Candidate

Phase 2

Completed

• Conditions: Influenza
• Interventions: Biological: GSK1247446A; Biological: Fluarix™

• Registration Number: NCT00374842
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The purpose of this study is to evaluate the immunogenicity and the safety of candidate vaccines compared to Fluarix™ administered intramuscularly in subjects aged 18-59 years

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-09-08
• Study First Submitted QC: 2006-09-08
• Study First Posted: 2006-09-12
• Study Start: 2006-10-03
• Primary Completion: 2006-11-01
• Study Completion: 2006-11-30
• Results First Submitted: 2013-03-07
• Results First Submitted QC: 2013-03-07
• Results First Posted: 2013-04-22
• Status Verified: 2016-10
• Last Update Submitted: 2018-05-09
• Last Update Posted: 2018-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• A male or female aged 18-59 years at the time of the first vaccination.
• Free of obvious health problems

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Exclusion Criteria

• Use of non-registered products
• Administration of immune-modifying drugs.
• Administration of vaccine 30 days before enrolment in study.
• Immunosuppressive or immunodeficient condition.
• Hypersensitivity to a previous dose of influenza vaccine
• Previous vaccination against influenza in 2006
• Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
• History of confirmed influenza infection within the last 12 Months.
• Acute disease at the time of enrolment/vaccination.
• History of allergy or reactions likely to be exacerbated by any component of the vaccine

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GSK1247446A Formulation 2 Group	GSK1247446A	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 Group	Fluarix™	Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
GSK1247446A Formulation 1 Group	GSK1247446A	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Within the 7-day follow-up period (Days 0-6) after vaccination	Assessed solicited general symptoms were arthralgia, fatigue, fever (axillary temperature higher than or equal to (\>=) 37.5 degrees Celsius (°C)), headache, muscle aches, and shivering. Any = Occurrence of a particular symptom regardless of intensity or relationship to vaccination. Grade 3 symptom = Symptom which prevented normal activity. Related = Symptom assessed by the investigator as causally related to the study vaccination. Grade 3 fever = axillary temperature higher than 39.0°C.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Within the 7-day follow-up period (Days 0-6) after vaccination	Assessed solicited local symptoms were ecchymosis, pain, redness and swelling the site of injection. Any = occurrence of a solicited local symptom regardless of intensity grade. Grade 3 pain = Pain which prevented normal activity. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling at injection site with a diameter larger than (\>) 50 millimeters (mm). All solicited local symptoms assessed were considered by the investigator as causally related to the study vaccination.
Number of Subjects With Any and Related Serious Adverse Events (SAEs)	From study start to study end, from Day 0 to Day 30	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 SAE = any occurrence of an SAE, regardless of relationship to study vaccination. A related SAE = an SAE assessed by the investigator as causally related to the study vaccination.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)	Within the 30-day follow-up period (Days 0-29) after vaccination	An unsolicited AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. Any AE = any occurrence of an AE, regardless of intensity or relationship to study vaccination. Grade 3 = an event that prevented normal activity. Related = event assessed by the investigator as causally related to the study vaccination.

Trial Locations

Locations (1)

GSK Investigational Site; 🇧🇪 Wilrijk, Belgium