Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Trivalent Split Virion Influenza Vaccine Fluviral™ (2013-2014 Season) in Adults Aged 18 Years and Older

NCT ID: NCT01878825

Last Updated: 2018-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-18
• Study Completion Date: 2013-08-09

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.

Conditions

Influenza

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Fluviral 18-60 Years Group

Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Group Type: EXPERIMENTAL

Fluviral™

Intervention Type: BIOLOGICAL

1 dose administered intramuscularly in deltoid region of non-dominant arm.

Fluviral >60 Years Group

Subjects aged \> 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm

Group Type: EXPERIMENTAL

Fluviral™

Intervention Type: BIOLOGICAL

1 dose administered intramuscularly in deltoid region of non-dominant arm.

Interventions

Fluviral™

1 dose administered intramuscularly in deltoid region of non-dominant arm.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Sherbrooke, Quebec, Canada

Countries

Canada

Related Links

https://clinicalstudydatarequest.com

IPD for this study will be made available via the Clinical Study Data Request site.

Other Identifiers

200190

Identifier Type: -

Identifier Source: org_study_id