Immunogenicity and Safety of Vaccine GSK2340272A (H1N1) and GSK Biologicals Fluarix™ Vaccine When Co-administered in Elderly

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Influenza

Treatments: Biological: Placebo; Biological: Pandemrix (Influenza vaccine GSK2340272A); Biological: Fluarix™

Study type: Interventional

Funder types: Industry

Identifiers

NCT00968890

113525

Details and patient eligibility

About

The purpose of the present study is to assess the immunogenicity, safety and reactogenicity of a two-dose schedule with vaccine GSK2340272A when co-administered with GSK Biologicals' Fluarix™ vaccine either at the time of first or second vaccination in elderly subjects aged 61 years and older.

Full description

The study will be conducted in an open manner regarding the administration of vaccine GSK2340272A.

The study will be observer-blind regarding the administration of Fluarix™ and placebo vaccines.

Enrollment: 168 patients

Sex: All

Ages: 61+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female subjects 61 years of age or older at the time of the first vaccination
• Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
• Written informed consent obtained from the subject.
• Satisfactory baseline medical assessment by history and physical examination.
• Access to a consistent means of telephone contact.

Exclusion criteria

• Previous administration of the 2009 Southern Hemisphere or 2009-2010 Northern Hemisphere seasonal influenza vaccine.
• Previous administration of a pandemic influenza vaccine.
• Administration of any vaccine within 30 days before first vaccination.
• Planned administration of a vaccine not foreseen by the study protocol one month (minimum 30 days) after the second vaccination with vaccine GSK2340272A.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of the study vaccines or planned use during the study period. Potential subjects in the follow-up (i.e., no treatment) phase of a prior investigational study may be enrolled if the investigator's judgment is that it will have no effect on safety, reactogenicity, or immunogenicity endpoints in this study, and that it does not violate the protocol requirements of the prior trial.
• Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
• Presence of an oral temperature >= 37.5°C, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
• Diagnosed with cancer, or treatment for cancer, within 3 years.
• Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
• Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to the first vaccination.
• Receipt of any immunoglobulins and/or any blood products within 3 months preceding the first vaccination or planned administration of any of these products during the entire study period.
• Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic anti-platelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency, are eligible.
• An acute evolving neurological disorder or history of Guillain-Barré syndrome.
• Serious chronic disease as determined by medical history and physical examination.
• Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormalities, as determined by physical examination or laboratory screening tests.
• Any known or suspected allergy to any constituent of influenza vaccines.
• History of chronic alcohol consumption and/or drug abuse.
• Clinically or virologically confirmed influenza infection within 6 months preceding the study start.
• Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

168 participants in 2 patient groups

Pandemrix+Fluarix and Pandemrix+Placebo

Experimental group

Description:

Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.

Treatment:

Biological: Placebo

Biological: Pandemrix (Influenza vaccine GSK2340272A)

Biological: Fluarix™

Pandemrix+Placebo and Pandemrix+Fluarix

Experimental group

Description:

Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.

Treatment:

Biological: Placebo

Biological: Pandemrix (Influenza vaccine GSK2340272A)

Biological: Fluarix™