Safety and Immune Response Study of GSK Biologicals' Influenza Virus Vaccine 1388442A Compared With Fluarix

Study Overview
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Brief Summary
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The purpose of the study is to compare the safety of & immune response to a single dose of GSK Biologicals' cell-culture based influenza vaccine 138842A with that of a US licensed, egg-based trivalent influenza vaccine [Fluarix] in healthy adults.

Official Title
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Safety and Immunogenicity Study of GSK Biologicals' Cell Culture-based Influenza Virus Vaccine 1388442A Compared With US Licensed TIV in Healthy Adults

Conditions
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Influenza

Intervention / Treatment
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* Biological: Trivalent influenza vaccine GSK 138842A
* Biological: Fluarix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who the investigator believes can and will comply with the requirements of the protocol A male or non-pregnant, non-lactating female between 18 and 49 years of age at the time of vaccination Access to a telephone for scheduled follow-up telephone contacts Ability to provide written informed consent Healthy subjects as established by medical history and physical examination before entering into the study If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination and continue such precautions for 2 months after receipt of the study vaccine. All women will have a pregnancy test on the day of vaccination. Exclusion Criteria: Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period Receipt of systemic glucocorticoids within 30 days of study enrollment Administration of immunosuppressant, cytotoxic, or other immune-modifying drugs (other than glucocorticoids) or irradiation within 6 months prior to study enrollment or planned administration during the study period Administration of immunoglobulins and/or blood products within 3 months prior to study enrollment or planned administration during the study period Previous vaccination against influenza (2007-2008 influenza season) History of anaphylactic or other allergic reaction to influenza vaccine, any other vaccine, or any vaccine component or excipient History of Guillain-Barre Syndrome (GBS) Acute disease, febrile illness, or upper respiratory infection at screening. History of splenectomy Any confirmed or suspected, acquired, congenital, or hereditary immunodeficiency or immunosuppressive condition (including human immunodeficiency virus [HIV]) based on medical history and physical examination Acquired or congenital coagulation disorders or known thrombocytopenia Current treatment with warfarin or heparin derivatives Known use of an analgesic or antipyretic medication within 12 hours prior to treatment for the purposes of prophylaxis of adverse events Any medical condition for which the US Advisory Committee on Immunization Practices recommends vaccination against influenza

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 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: GSK 1388442A Group<br>Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | Biological: Trivalent influenza vaccine GSK 138842A<br>* IM injection on Day 0<br>|
| Active Comparator: Fluarix Group<br>Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | Biological: Fluarix<br>* IM injection on Day 0<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Solicited Local Symptoms. | Solicited local symptoms were pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. | During the 7-day (Days 0-6) post vaccination period | 
| Number of Subjects With Solicited General Symptoms. | Solicited general symptoms were arthralgia, fatigue, headache, muscle aches, shivering and temperature, assessed as oral temperature above or equal (≥) 38.0 degrees Celsius (°C). Any = occurrence of a symptom regardless of intensity or relationship to vaccination. | During the 7-day (Days 0-6) post vaccination period | 
| Number of Subjects With Medically Attended Adverse Events (MAEs). | Medically-attended events (MAEs) refer to non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits and hospitalization. Related MAE = MAE assessed by the investigator as related to the vaccination. | During the entire study period (Days 0-182) | 
| Number of Subjects With New Onset of Chronic Diseases (NOCDs). | NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies. | During the entire study period (Days 0-182) | 
| Number of Subjects With Unsolicited Adverse Events (AEs). | Unsolicited AEs cover any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination. | During the 90-day (Days 0-89) post-vaccination period | 
| Number of Subjects With Serious Adverse Events (SAEs). | Serious adverse events (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 SAE regardless of intensity or relationship to vaccination. | During the entire study period (Days 0-182) | 
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies for 3 Strains of Influenza Disease. | Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.) | At Day 21 | 
| Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. | A seroprotected subject was defined as a vaccinated subject with a serum HI antibody titer ≥ 1:40, a level of HI antibody that has been viewed as correlating with protection against influenza. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.) | At Day 21 | 
| Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. | 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/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.) | At Day 21 | 
| Geometric Mean Fold-rise (GMFR) in 3 Strains of Influenza Disease. | GMFR was defined as the geometric mean of the ratio of the post-vaccination inverse HI titer to the Day 0 inverse HI titer. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.) | At Day 0 and Day 21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cell culture, Safety, Influenza, Humans, Adults, Immunogenicity, Influenza vaccine, Vaccine