Clinical trial NCT00929331: Immunogenicity & Safety Study of Fluviral® (2009 - 2010 Season) in Adults Aged 18 to 60 Years and Over 60 Years
Official title: Immunogenicity and Safety Study of GSK Biologicals' Trivalent Split Virion Influenza Vaccine Fluviral® (2009 - 2010 Season) in Adults Aged 18 to 60 Years and Over 60 Years.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza, Human
Keywords: Influenza
Fluviral®
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-06-29
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies
timeFrame: At Day 0
measure: GMTs of HI Antibodies
timeFrame: At Day 21 after vaccination
measure: Number of Subjects With a Serum HI Titer Equal to or Above the Cut-off Value
timeFrame: At Day 0
measure: Number of Subjects With a Serum HI Titer Equal to or Above the Cut-off Value
timeFrame: At Day 21 after vaccination
measure: Number of Seroconverted Subjects
timeFrame: At Day 21 after vaccination
measure: Seroconversion Factors
timeFrame: At Day 21 after vaccination
measure: 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
timeFrame: At Day 21 after vaccination
Secondary outcomes:
measure: Number of Subjects Reporting Any Solicited Local Symptoms
timeFrame: During a 4-day (Day 0-3) follow-up period after vaccination
measure: Number of Subjects Reporting Grade 3 Solicited Local Symptoms
timeFrame: During a 4-day (Day 0-3) follow-up period after vaccination
measure: Number of Subjects Reporting Any Solicited General Symptoms
timeFrame: During a 4-day (Day 0-3) follow-up period after vaccination
measure: Number of Subjects Reporting Grade 3 Solicited General Symptoms
timeFrame: During a 4-day (Day 0-3) follow-up period after vaccination
measure: Number of Subjects Reporting Related Solicited General Symptoms
timeFrame: During a 4-day (Day 0-3) follow-up period after vaccination
measure: Number of Subjects Reporting Unsolicited Adverse Events (AEs)
timeFrame: During a 21-day (Day 0-20) follow-up period after vaccination
measure: Number of Subjects With Serious Adverse Events
timeFrame: From the beginning up to the end of the study (Day 0 - Day 21)
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: GSK Investigational Site
state: Quebec
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: