Immunogenicity & Safety Study of Fluviral® (2010 - 2011 Season) in Adults Aged 18 to 60 Years and Over 60 Years

Phase 3

Completed

Conditions: Influenza

Interventions: Biological: Fluviral®

Registration Number: NCT01153685

Lead Sponsor: GlaxoSmithKline

Brief Summary: This study is designed to test the safety and immunogenicity of Fluviral® (2010 - 2011 Season) in adults aged 18 to 60 years and over 60 years.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 120

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.
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 (2009) Fluviral registration study
Administration of any influenza vaccine within 6 months preceding the study start (35 or more subjects in the >60 year old age stratum will be recruited from among those who did NOT receive any inactivated influenza vaccine in 2009-2010 season, i.e. seasonal TIV or pandemic H1N1v).
Administration of any other vaccine(s) 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.
Clinically or virologically confirmed influenza infection within 1 year preceding the study start.
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.
Acute disease at the time of enrollment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever). 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 (prednisone >= 20 mg/day for more than 14 consecutive days) 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.
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 (egg protein, thimerosal) and/or a history of anaphylactic type reaction to consumption of eggs, and/or reactions to products containing mercury (such as thimerosal).
A history of severe adverse reaction to a previous influenza vaccination.
Pregnant and/or 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 A Group	Fluviral®	Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
Fluviral B Group	Fluviral®	Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.

Primary Outcome Measures

Name	Time	Method
Number of Seroconverted Subjects for Antibodies Against Fluviral Vaccine Strains.	At Day 21 after vaccination	A subject seroconverted for haemagglutination inhibition (HI) antibodies was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.
Seroconversion Factor for Antibodies Against Fluviral Vaccine Strains.	At Day 21 after vaccination	Seroconversion Factor (SCF) is defined as the fold increase in serum HI antibody GMTs post-vaccination (Day 21) compared to prevaccination (Day 0).
Geometric Mean Titers (GMTs) of Haemagglutination Inhibition (HI) Antibodies Against Fluviral Vaccine Strains.	At Day 21 after vaccination	The Fluviral vaccine strains were A/California (H1N1), A/Victoria (H3N2) and B/Brisbane
Number of Seroprotected Subjects for Antibodies Against Fluviral Vaccine Strains.	At Day 21 after vaccination	A Seroprotected subject was defined as a subject with a serum haemagglutination inhibition (HI) antibody titer greater than or equal to 1:40.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With Solicited Local and General Symptoms After Administration of Fluviral.	During a 4-days (Day 0-3) follow-up period after vaccination.	Solicited local symptoms assessed were pain, redness and swelling at the injection site. Solicited general symptoms assessed were bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face and temperature (defined as orally temperature equal or above 38.0 degrees Celcius)
Number of Subjects With Serious Adverse Events (SAEs)	During the entire study period	SAEs assessed include medical occurences that results 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.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)	Within the 21-day post-vaccination period	Unsolicited adverse events (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptoms with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of any adverse event regardless of intensity grade or relationship to vaccination. Grade 3 = an unsolicited AE that prevented normal everyday activity. Related = event assessed by the investigator as causally related to the vaccination.
Number of Subjects Reporting Unsolicited Adverse Events (AEs).	Within the 21-day 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.