A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Adults

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Influenza

Treatments: Biological: FluLavalTM-VB; Biological: FluLavalTM-YB; Biological: Quadrivalent seasonal influenza vaccine GSK2282512A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01196975

112963

Details and patient eligibility

About

This study is designed to test the immunogenicity and safety of an investigational influenza vaccine, in adults compared to two other influenza vaccines.

This study will also evaluate the lot-to-lot consistency of three vaccine lots.

Enrollment: 1,707 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who the investigator believes can and will comply with the requirements of the protocol
• A male or female 18 years of age or older, in stable health, as established by medical history and physical examination before entering into the study.
• Written informed consent obtained from the subject.
• Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line, or mobile, but NOT a pay phone or other multiple-user device.
• 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

• Use of an investigational / non-registered product other than the study vaccines within 30 days before study vaccination or planned use during study period.
• Planned administration or administration of a licensed vaccine within 30 days before study vaccination.
• Prior receipt of 2010/2011 influenza vaccine.
• Receipt of any investigational or approved influenza vaccine within six months of the first study visit.
• Any known or suspected allergy to any constituent of influenza vaccines ; a history of anaphylactic-type reaction to constituent of vaccine; or a history of severe adverse reaction to a previous influenza vaccine.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
• History of Guillain-Barre syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
• Presence or evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the investigator to render the potential subject unable / unlikely to provide accurate safety reports.
• Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, based on history and physical examination.
• Presence of significant uncontrolled chronic medical or neuropsychiatric illness, based on history and physical examination
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin
• Chronic administration of immunosuppressants or other immune-modifying drugs within 3 months prior to the first vaccine/product dose.
• Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
• Pregnant or lactating female.
• Fever at the time of enrolment.
• Acute disease at the time of enrolment
• Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,707 participants in 5 patient groups

GSK2282512A 1 Group

Experimental group

Description:

Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Treatment:

Biological: Quadrivalent seasonal influenza vaccine GSK2282512A

GSK2282512A 2 Group

Experimental group

Description:

Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Treatment:

Biological: Quadrivalent seasonal influenza vaccine GSK2282512A

GSK2282512A 3 Group

Experimental group

Description:

Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Treatment:

Biological: Quadrivalent seasonal influenza vaccine GSK2282512A

Victoria Strain FluLaval Group

Active Comparator group

Description:

Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Treatment:

Biological: FluLavalTM-VB

Yamagata Strain FluLaval Group

Active Comparator group

Description:

Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Treatment:

Biological: FluLavalTM-YB