Clinical trial NCT00540228: Study to Evaluate an Influenza Vaccine Candidate
Official title: Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Influenza Vaccine GSK1247446A With Various Formulations in Subjects Aged 18-64 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: Influenza
Influenza Vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-10-05
Enrollment: 1006
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
timeFrame: At Days 0, 21 and 180
Secondary outcomes:
measure: Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
timeFrame: At Days 21 and 180
measure: Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
timeFrame: At Days 21 and 180
measure: Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
timeFrame: At Days 0, 21 and 180
measure: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
timeFrame: At Days 0 and 21
measure: Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
timeFrame: At Days 0, 21 and 180
measure: Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
timeFrame: At Days 0, 21 and 180
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
timeFrame: During the 7-day (Days 0-6) post vaccination period
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
timeFrame: During the 7-day (Days 0-6) post vaccination period
measure: Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs).
timeFrame: From Day 0 to Day 180
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
timeFrame: During the 21-day (Days 0-20) post vaccination period
measure: Number of Subjects With Serious Adverse Events (SAEs).
timeFrame: From Day 0 to Day 180
Other outcomes:
Locations:
city: Caen cedex 4
country: France
facility: GSK Investigational Site
city: Lagord
country: France
facility: GSK Investigational Site
city: Lille
country: France
facility: GSK Investigational Site
city: Paris Cedex 18
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Toulouse
country: France
facility: GSK Investigational Site
city: Tuebingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Wuerzburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Freiberg
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Schmiedeberg
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: