Safety and Immunogenicity Study of GSK Biologicals' Seasonal Influenza Candidate Vaccine (GSK2321138A)

Phase 3CompletedNCT01204671

GlaxoSmithKline4,659 enrolled

Overview

This study is designed to assess the safety and immunogenicity of a GSK Biologicals' investigational vaccine GSK2321138A in adults 18 years old and older. This study is also designed to assess the lot-to-lot consistency of vaccine GSK2321138A. The blinding will be double blind for all groups except for the GSK2604409A Group which will be open.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

4,659

Conditions

Influenza

Interventions

Influenza vaccine GSK2321138ABIOLOGICAL

One intramuscular injection

FluarixTMBIOLOGICAL

One intramuscular injection

Influenza vaccine GSK2604409ABIOLOGICAL

One intramuscular injection

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * A male or female 18 years of age or older at the time of the first vaccination * Subjects who the investigator believes can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject. * Healthy subjects or those with chronic well-controlled disease as established by physical examination before entering into the study. * 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 urine 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 any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of the study vaccine or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period. * Administration of an influenza vaccine during the 6 months preceding entry into the study. * Planned administration / administration of a vaccine not foreseen by the study protocol within 30 days before vaccination and up to Day 21. * Any contra-indication to intramuscular administration of the influenza vaccines. * History of hypersensitivity/anaphylaxis to a previous dose of influenza vaccine, history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. * Any administration of a long-acting immune-modifying drug within 3 months before study start, or planned administration during the study period. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * Acute disease and/or fever at the time of enrolment. * Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * History of Guillain-Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine. * Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study. * History of chronic alcohol consumption and/or drug abuse. * Any condition which, in the opinion of the investigator, prevents the subject from participating in the study * Pregnant or lactating female.

Locations (42)

Outcomes

Primary Outcomes

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

Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. HI antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.

Time frame: At Day 0 (D 0), and at Day 21 (D 21)

Number of Seroconverted Subjects Against 4 Strains of Influenza Disease

A seroconverted subject was a vaccinated subject who had either a pre-vaccination hemagglutination inhibition (HI) antibody titer \< 1:10 and a post-vaccination titer above or equal (\>=) 1:40, or a pre-vaccination HI antibody titer \>= 1:10 and at least a 4-fold increase in post-vaccination HI antibody titer. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.

Time frame: At Day 21 (D 21)

Secondary Outcomes

Number of Seropositive Subjects Against 4 Strains of Influenza Disease

A seropositive subject was a vaccinated subject with hemagglutination inhibition (HI) antibody titer above or equal (\>=) the reference cut-off value of 1:10. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.

Time frame: At Day 0 (D 0), and at Day 21 (D 21)

Number of Seroprotected Subjects Against 4 Strains of Influenza Disease

A seroprotected subject was a vaccinated subject who had hemagglutination inhibition (HI) antibody titer above or equal (\>=) 1:40. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.

Data from ClinicalTrials.gov

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GSK Investigational Site

Chandler, Arizona, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Newton, Kansas, United States

GSK Investigational Site

Lexington, Kentucky, United States

GSK Investigational Site

Columbia, Maryland, United States

GSK Investigational Site

Milford, Massachusetts, United States

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

Salisbury, North Carolina, United States

GSK Investigational Site

Erie, Pennsylvania, United States

GSK Investigational Site

Nashville, Tennessee, United States

...and 32 more locations