Immunogenicity & Safety Study of Fluviral® (2009 - 2010 Season) in Adults Aged 18 to 60 Years and Over 60 Years

Phase 3

Completed

Conditions: Influenza, Human

Interventions: Biological: Fluviral®

Registration Number: NCT00929331

Lead Sponsor: GlaxoSmithKline

Brief Summary: This study is designed to test the safety and immunogenicity of Fluviral® (2009 - 2010 Season) in adults aged 18 to 60 years and over 60 years.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 110

Inclusion Criteria

Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
Written informed consent obtained from the subject
Male and female adults, 18 to 60 years of age and over 60 years of age.
Satisfactory baseline medical assessment by history and physical examination
Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits.
Female subjects of non-childbearing potential may be enrolled in the study.
- Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria

Participation in previous year's (2008) Fluviral® registration study
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s)/product(s) within 30 days preceding the first dose of study vaccine/product, or planned use during the study period.
Acute disease at the time of enrollment. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral temperature <38.0°C.
Significant acute or chronic, uncontrolled medical or psychiatric illness. "Uncontrolled" is defined as:

Requiring institution of new medical or surgical treatment within one (1) month prior to study enrollment, or Requiring the re-institution of a previously discontinued medication or medical treatment within one month prior to study enrollment, or Requiring a change in medication dosage in the one month prior to study enrollment due to uncontrolled symptoms or drug toxicity (elective dosage adjustments in stable subjects are acceptable), or Hospitalization or an event fulfilling the definition of a SAE within one month prior to study enrollment.

• Any confirmed or suspected immunosuppressive condition including: History of human immunodeficiency virus (HIV) infection, Cancer or treatment for cancer, within 3 years of study enrollment. Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.

History of renal impairment.
History of hepatic dysfunction due to hepatitis B, C or toxins including alcohol.
Complicated insulin-dependent diabetes mellitus.
Unstable cardiopulmonary disease requiring chronic medical therapy or associated with functional impairment.
Presence of blood dyscrasias, including hemoglobinopathies and myelo- or lymphoproliferative disorder.
Receipt of systemic glucocorticoids within 1 month of study enrollment, or any cytotoxic or immunosuppressive drugs within six months of study enrollment. Inhaled and topical steroids are allowed.
A history of any demyelinating disease including Multiple Sclerosis and Guillain-Barré syndrome.
Presence of an active neurological disorder.
History of chronic alcohol consumption and/or drug abuse.
Any significant disorder of coagulation that increases the risk of intramuscular injections or treatment with coumadin derivatives or heparin. Persons receiving prophylactic antiplatelet medications, e.g. low-dose aspirin, and without a clinically-apparent bleeding tendency are eligible.
Receipt of an influenza vaccine within 6 months prior to study enrollment.
Administration of any vaccines within 30 days prior to study enrollment or during the study period. Subjects who receive such treatment after enrollment will be followed per protocol and included in the safety analysis, but excluded from the according-to-protocol cohort.
Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
Any known or suspected allergy to any constituent of Fluviral® and/or a history of anaphylactic type reaction to constituent of the vaccine.
A history of severe adverse reaction to a previous influenza vaccination.
Lactating/nursing female.
Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluviral Elderly Group	Fluviral®	Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
Fluviral Adult Group	Fluviral®	Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm

Primary Outcome Measures

Name	Time	Method
GMTs of HI Antibodies	At Day 21 after vaccination	Data are displayed as GMTs for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.
Number of Subjects With a Serum HI Titer Equal to or Above the Cut-off Value	At Day 21 after vaccination	The cut-off value was defined as a serum HI titer \>= 1:40, which is usually accepted as indicating protection. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.
Number of Subjects With a Pre-vaccination Titer Below the Cut-off Value and a Post-vaccination Titer Equal to or Above the Cut-off Value	At Day 21 after vaccination	The cut-off value was a titer of 1:40. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies	At Day 0	Data are displayed as GMTs for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.
Number of Seroconverted Subjects	At Day 21 after vaccination	A seroconverted subject is a subject who had either a prevaccination 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. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.
Seroconversion Factors	At Day 21 after vaccination	Seroconversion factors are defined as the fold increase in serum HI GMTs post-vaccination (Day 21) compared to pre-vaccination (Day 0). Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Reporting Any Solicited Local Symptoms	During a 4-day (Day 0-3) follow-up period after vaccination	Solicited local symptoms assessed include pain, redness and swelling at the site of injection. Any = Solicited local symptoms are presented regardless of their intensity grade
Number of Subjects Reporting Any Solicited General Symptoms	During a 4-day (Day 0-3) follow-up period after vaccination	Solicited local symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, temperature (orally) in degrees celsius. Any = solicited general symptoms are presented regardless of their intensity grade or relationship to vaccination. For temperature this means equal to or above 38.0 degrees celsius.
Number of Subjects Reporting Grade 3 Solicited General Symptoms	During a 4-day (Day 0-3) follow-up period after vaccination	Solicited local symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, temperature (orally) in degrees celsius. Grade 3 general symptom = symptom that prevented normal activity Grade 3 temperature = temperature above 39.0 degrees celsius
Number of Subjects Reporting Grade 3 Solicited Local Symptoms	During a 4-day (Day 0-3) follow-up period after vaccination	Solicited local symptoms assessed include pain, redness and swelling at the site of injection. Grade 3 pain = pain that prevented normal activity, Grade 3 redness/swelling = redness/swelling \> 100 mm
Number of Subjects Reporting Related Solicited General Symptoms	During a 4-day (Day 0-3) follow-up period after vaccination	Solicited local symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, temperature (orally) in degrees celsius. Related = general symptom assessed by the investigator as related to the vaccine
Number of Subjects Reporting Unsolicited Adverse Events (AEs)	During a 21-day (Day 0-20) follow-up period after vaccination	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 = unsolicited adverse event regardless of intensity. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination.
Number of Subjects With Serious Adverse Events	From the beginning up to the end of the study (Day 0 - Day 21)	SAEs assessed include medical occurrences that result in death, is 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.