A Study for Evaluation of GSK Biologicals' Pandemic Influenza Vaccine

Study Overview
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Brief Summary
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This observer-blind study is designed to evaluate the immune response and safety of pandemic influenza vaccine in the elderly population.

Official Title
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Immunogenicity and Safety of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine GSK 1562902A.

Conditions
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Influenza

Intervention / Treatment
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* Biological: GSK's candidate influenza vaccine 1562902A
* Biological: FluarixTM
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects aged 61 years or above at the time of the first study visit (Day -30). Female subjects of non-childbearing potential. Healthy subjects or subjects with well controlled chronic medical condition (at the discretion of the investigator). Written informed consent obtained from the subject. Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device. Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. Exclusion Criteria: Previous administration of the licensed MF59-containing vaccines, e.g. Fluad™ or Addigrip™ or virosome-based influenza vaccines such as Inflexal V™, InfectoVac Flu™ or Invivac™ . Previous administration of the 2009 Southern Hemisphere or 2008-2009 Northern Hemisphere influenza vaccine. Previous administration of a pandemic influenza vaccine. Administration of licensed vaccines within 4 weeks prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after the second vaccination with H5N1 vaccine. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first study vaccination. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). History of chronic alcohol consumption and/or drug abuse. History of hypersensitivity to vaccines. History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. Acute 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. Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination.. Administration of immunoglobulins and/or any blood products within the three months preceding the first study vaccination or during the study. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days prior to the first vaccination, or planned use during the study period. Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

Ages Eligible for Study
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Minimum Age: 61 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: Group A<br> | Biological: GSK's candidate influenza vaccine 1562902A<br>* Intramuscular dose on Day 0 and Day 21<br>Biological: FluarixTM<br>* Intramuscular dose on Day 42 or on Day -30, according to the vaccination schedule<br>Biological: Placebo<br>* Intramuscular dose on Day 42 or on Day -30, according to the vaccination schedule<br>|
| Experimental: Group B<br> | Biological: GSK's candidate influenza vaccine 1562902A<br>* Intramuscular dose on Day 0 and Day 21<br>Biological: FluarixTM<br>* Intramuscular dose on Day 42 or on Day -30, according to the vaccination schedule<br>Biological: Placebo<br>* Intramuscular dose on Day 42 or on Day -30, according to the vaccination schedule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum HI antibody titres |  | Day -30, Day 42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum HI antibody titres |  | Day -30, Day 42, Month 6, Month 12 | 
| Serum neutralising antibody titres |  | Day -30, Day 42, Month 6, Month 12 | 
| Occurrence, intensity, and relationship to vaccination of solicited local and general signs and symptoms |  | Day 0 - Day 6 after each vaccination | 
| Occurrence, intensity and relationship to vaccination of unsolicited adverse events |  | Day 0 - Day 29 after vaccination, Day 0 - Day 20 after investigational vaccination | 
| Occurrence and relationship to vaccination of serious adverse events |  | Day 0 - Month 6 | 
| Occurrence of adverse events of specific interest |  | Day 0 - Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pandemic influenza