Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine for the Elderly

Study Overview
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Brief Summary
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The objective of the study is to evaluate immunogenicity between different formulations of GSK Biologicals' investigational vaccine GSK2186877A.

Official Title
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Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine GSK2186877A in Elderly Adults.

Conditions
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Influenza

Intervention / Treatment
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* Biological: GSK investigational FluNG vaccine GSK2186877A, aged lot
* Biological: GSK investigational FluNG vaccine GSK2186877A, fresh lot


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. Specific attention should be given to the compliance potential of subjects with suspected or known drug or alcohol abuse. A man or woman 65 years of age or older at the time of vaccination. Written informed consent obtained from the subject. Free of an acute aggravation of the health status as established by clinical evaluation before entering into the study. Exclusion Criteria: Any confirmed or suspected influenza illness within the last 6 months. Previous vaccination against influenza with any seasonal vaccine since December 2008. Planned administration of an influenza vaccine other than the study vaccines during the entire study period. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period. Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to Visit 2. Administration of immunoglobulins and/or any blood products within the 3 months preceding the dose of study vaccine or planned administration during the study period. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. For corticosteroids, this will mean prednisone >= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s) including egg and chicken protein, included history of hypersensitivity to a previous dose of influenza vaccine. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. Acute disease and/or fever at the time of enrolment. Fever is defined as temperature >= 37.5°C on oral setting. Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. Any medical conditions in which intramuscular injections are contraindicated.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FluNG Aged Group<br>Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A). | Biological: GSK investigational FluNG vaccine GSK2186877A, aged lot<br>* Single dose, intramuscular injection<br>|
| Experimental: FluNG Fresh Group<br>Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A). | Biological: GSK investigational FluNG vaccine GSK2186877A, fresh lot<br>* Single dose, intramuscular injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains | Titers are presented as Geometric Mean Titers. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane. | At Days 0 and 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Seropositive Against the 3 Vaccine Strains | A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane. | At Days 0 and 21 | 
| Number of Subjects Seroconverted for the 3 Vaccine Strains | A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane. | At Day 21 | 
| Seroconversion Factor for the 3 Vaccine Strains | Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane. | At Day 21 | 
| Number of Subjects Seroprotected for the 3 Vaccine Strains | A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. | At Days 0 and 21 | 
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms | Local symptoms assessed include ecchymosis, pain, redness and swelling. General symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, muscle aches, shivering and fever [oral temperature greater than or equal to 38 degrees Celsius (°C)]. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter. Grade 3 fever: oral temperature greater than or equal to 39°C. Related: general symptom assessed by the investigator as causally related to the study vaccination. | During the 7-day post-vaccination period | 
| Duration of Solicited Local and General Symptoms | Local symptoms assessed include ecchymosis, pain, redness and swelling. General symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, muscle aches, shivering and fever. Duration is expressed as median number of days the specific symptom was experienced. | During the 7-day post-vaccination period | 
| Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | 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. | During the 21-day post-vaccination period | 
| Number of Subjects Reporting Adverse Events of Specific Interest (AESI) | AESIs for safety monitoring included autoimmune diseases and other immune mediated inflammatory disorders. | During the 21-day post-vaccination period | 
| Number of Subjects Reporting Serious Adverse Events (SAEs) | 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. | During the entire study period (up to Day 21) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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influenza infection, GSK Bio's influenza vaccine GSK2186877A