Study to Evaluate an Influenza Vaccine Candidate

GlaxoSmithKline1,006 enrolled

Overview

In order to find the formulation leading to a maximal increase of the immune response while maintaining an acceptable safety profile, this study is designed to evaluate the immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals' influenza vaccine administered in adults aged 18-64 years.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

1,006

Conditions

Influenza

Interventions

Influenza Vaccine GSK1247446A - 4 different formulationsBIOLOGICAL

Single dose, Intramuscular injection

Fluarix™BIOLOGICAL

Single dose, Intramuscular injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Only subjects who the investigator believes that they can and will comply with the requirements of the protocol . * A male or female between, and including, 18 - 64 years of age at the time of vaccination. * Written informed consent obtained from the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study. * If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must have a negative pregnancy test, practice adequate contraception for 30 days prior to vaccination, and continue such precautions for 2 months after completion of the vaccination series. Exclusion Criteria: * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose * Administration of a vaccine not foreseen by the study protocol from 30 days before vaccination, up to 21 days after vaccination. * History of hypersensitivity to a previous dose of influenza vaccine. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s) * Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * Confirmed influenza infection within a year preceding the study start. * Administration of an influenza vaccine within a year preceding the study start. * Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. * Pregnant or lactating female. * Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product * Acute disease at the time of enrolment. * History of chronic alcohol consumption and/or drug abuse. * Female planning to become pregnant or planning to discontinue contraceptive precautions. * Any condition which, in the opinion of the investigator, prevents the subject from participating in the study. * History of administration of experimental/licensed vaccine containing squalene and/or tocopherol within the last 12 months.

Locations (15)

GSK Investigational Site

Caen, France

GSK Investigational Site

Lagord, France

GSK Investigational Site

Lille, France

Outcomes

Primary Outcomes

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.

Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA). The seropositivity cut-off assay was 1:10. The results for Day 0 and Day 21 are the primary efficacy variables.

Time frame: At Days 0, 21 and 180

Secondary Outcomes

Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).

Time frame: At Days 21 and 180

Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.

The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).

Time frame: At Days 21 and 180

Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.

A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).

Time frame: At Days 0, 21 and 180

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.

Titers are presented as geometric mean titers (GMTs). The 4 influenza strains assessed were A/Wisconsin (WISC), B/Malaysia (MALA), A/Brisbane (BRIS) and B/Florida (FLOR). The seropositivity cut-off assay was 1:28.

Data from ClinicalTrials.gov

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