Clinical trial NCT01878825: Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Trivalent Split Virion Influenza Vaccine Fluviral™ (2013-2014 Season) in Adults Aged 18 Years and Older
Official title: Immunogenicity and Safety Study of GSK Biologicals' Trivalent Split Virion Influenza Vaccine (GSK1536489A) Fluviral™ (2013-2014 Season) in Adults Aged 18 Years and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Immunogenicity
Trivalent
Safety
Adults
Elderly
Influenza
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-06-17
Enrollment: 121
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: The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of Fluviral™ containing the influenza strains recommended for the 2013-2014 season in adults aged 18 years and older.


Eligibility criteria: Inclusion Criteria:

* Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
* A male or female 18 years of age and older at the time of the first vaccination.
* Written informed consent obtained from the subject.
* Healthy subjects or subjects with well-controlled chronic disease, as established by medical history and clinical examination before entering into the study.
* 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 dose.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine 30 days preceding the dose of study vaccine, or planned use during the study period.
* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. For corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
* Any administration of a long-acting immune-modifying drug (e.g. rituximab, infliximab etc.) within 6 months before study start, or planned administration during the study period.
* Administration of any influenza vaccine within 6 months preceding the study start or planned use of such vaccines during the study period.
* Administration of any other vaccine(s) within 30 days prior to study enrollment or during the study period.
* Clinically or virologically confirmed influenza infection within the 6 months preceding the study vaccination.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required):

  * 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.
* Acute disease and/or fever at the time of enrollment.

  * Acute disease is defined as the presence of a short term, moderate or severe illness, with or without fever.
  * Fever is defined as temperature ≥ 38.0°C/100.4°F for oral, axillary or tympanic route. The preferred route for recording temperature in this study will be oral.
  * Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
* Significant acute or chronic, uncontrolled medical or psychiatric or neurological illness. "Uncontrolled" is defined as:

  * Requiring institution of new medical or surgical treatment within one 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.
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
* Subjects who participated in the registration trial \[116664 (FLU Q-TIV-014)\] for Fluviral™ 2012/2013 conducted in the 2012-2013 season.
* Presence of blood dyscrasias, including hemoglobinopathies and myelo- or lymphoproliferative disorder.
* A history of any demyelinating disease including Multiple Sclerosis and Guillain-Barré syndrome.
* Administration of immunoglobulins and/or any blood products within the 3 months preceding the dose of study vaccine or planned administration during the study period.
* Any known or suspected allergy to any constituent of Fluviral™ and/or a history of anaphylactic type reaction to consumption of eggs, and/or reactions to products containing mercury.
* A history of severe adverse reaction to a previous influenza vaccination.
* Pregnant or lactating female.
* History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
* Any condition which, in the opinion of the investigator, prevents the subject from participation in the study or would make the intramuscular injection unsafe.

Primary outcomes:
measure: Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains
timeFrame: At Days 0 and 21
measure: Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains.
timeFrame: At Day 21
measure: Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.
timeFrame: At Day 21
measure: Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains.
timeFrame: At Days 0 and Day 21
Secondary outcomes:
measure: Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains
timeFrame: At Days 0 and Day 21
measure: Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains.
timeFrame: At Day 21
measure: Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.
timeFrame: At Day 21
measure: Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains.
timeFrame: At Day 0 and Day 21
measure: Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
timeFrame: During the 4-day (Days 0-3) post-vaccination period
measure: Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
timeFrame: During the 4-day (Days 0-3) post-vaccination period
measure: Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
timeFrame: During the 21-day (Days 0-20) post-vaccination period
measure: Number of Subjects Reporting Any Serious Adverse Events (SAEs)
timeFrame: During the entire study period (Days 0-20 post vaccination)
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: