Study to Evaluate the Immunogenicity and the Safety of an Adjuvanted Influenza Vaccine Candidate

Phase 2

Completed

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

• Registration Number: NCT00363077
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The purpose of this study is to evaluate the immunogenicity and the safety of the candidate vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years and above

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-08-07
• Study First Submitted QC: 2006-08-11
• Study First Posted: 2006-08-15
• Study Start: 2006-10-02
• Primary Completion: 2006-11-01
• Study Completion: 2006-11-17
• Results First Submitted: 2013-03-21
• Results First Submitted QC: 2013-03-21
• Results First Posted: 2013-05-07
• Status Verified: 2016-10
• Last Update Submitted: 2018-05-09
• Last Update Posted: 2018-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Subjects who the investigator believes that they can and wil comply with the requirements of the protocol should be enrolled in the study.
• A male or female 60 years or older 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
• Acute 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 Group	GSK1247446A Group	Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Fluarix Group	Fluarix™	Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.

Primary Outcome Measures

Name	Time	Method
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/Wisconsin and B/Malaysia. The seropositivity cut-off assay was 1:10.
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 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
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 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.	At Day 0 and Day 21	A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.

Secondary Outcome Measures

Name	Time	Method
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.	At Days 0 and 21	The geometric mean was calculated for CD4 T-cells (per million CD4 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-g), at least IL2 and at least TNF alpha (TNF-α).
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.	At Days 0 and 21	The geometric mean was calculated for CD8 T-cells (per million CD8 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-g), at least IL2 and at least TNF alpha (TNF-α).
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 considered to be related to 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 \[axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], 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 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 everyday activities. Related = unsolicited AE assessed by the investigator as related to the vaccination.
Number of Subjects With Any and Related Serious Adverse Events (SAEs).	During the entire study period (from Day 0 to Day 29)	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. Related = SAE considered by the investigator to have a causal relationship to study vaccination.

Trial Locations

Locations (1)

GSK Investigational Site; 🇧🇪 Gent, Belgium