Clinical trial NCT00529516: Evaluate Safety & Immunogenicity of GSK Bio's Influenza Vaccine GSK576389A After Repeated Vaccination in Elderly Adults
Official title: Observer Blind Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals Influenza Vaccine GSK576389A Administered to Adults Over 65 Years Previously Vaccinated With the Same Vaccine, Compared to Fluarix™
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Fluarix
GSK Bio's influenza vaccine GSK576389A
Influenza infection
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-09-14
Enrollment: 1252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Since influenza vaccines are administered every year because of the frequent change in their antigenic composition, the safety and immunogenicity profile of GSK Biologicals' influenza vaccine GSK576389A will be re-evaluated after repeated vaccine administration. In this observer blind study, the subjects previously enrolled in study 104888 (NCT00377585) will receive a dose with the 2007-2008 season's formulations of Fluarix or GSK576389A. Only subjects who were previously enrolled in study 104888 (NCT00377585) are eligible for participation in this study.

Detailed description: This study involves 2 age groups (based on primary study):

Subjects enrolled in the \>= 65 yrs age group in the primary study. Subjects enrolled in the 18-40 yrs age group in the primary study. The study will be conducted in an open manner for this age group.

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

Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
* Written informed consent obtained from the subject.
* Free of an acute aggravation of the health status as established by clinical evaluation 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 practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
* Male or female subjects who participated in the 104888 study (NCT00377585) and were enrolled in the \>= 65 years age group or in the 18-40 years age group .

Exclusion Criteria:

* Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study.
* Planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination
* Planned administration of an influenza vaccine other than the study vaccines during the entire study period
* Any vaccination against influenza since January 2007
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* History of hypersensitivity to a previous dose of influenza vaccine
* History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
* Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or pre-existing laboratory screening tests
* Acute disease at the time of enrolment
* 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
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, or planned use during the study period
* Any medical conditions in which IM injections are contraindicated
* Pregnant or lactating female, or planning to become pregnant or to discontinue contraceptive precautions.

Primary outcomes:
measure: Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
timeFrame: During a 7-day follow-up period after vaccination
measure: Duration of Solicited Local Adverse Events
timeFrame: During a 7-day follow-up period after vaccination
measure: Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs)
timeFrame: During a 7-day follow-up period after vaccination
measure: Duration of Solicited General Adverse Events
timeFrame: During a 7-day follow-up period after vaccination
measure: Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
timeFrame: During a 21-day follow-up period after vaccination
Secondary outcomes:
measure: Number of Subjects With Any and Related Serious Adverse Events (SAEs)
timeFrame: During the vaccination phase of the study (Day 0 to Day 20) and during the long term follow-up phase of the study (Day 21 to Day 179)
measure: Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs)
timeFrame: During the vaccination phase of the study (Day 0 to Day 20) and during the long term follow-up phase of the study (Day 21 to Day 179)
measure: Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains
timeFrame: At Days 0 and 21
measure: Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains
timeFrame: At Day 21
measure: Seroconversion Factors for HI Antibodies Against Each of the Three Vaccine Strains
timeFrame: At Day 21
measure: Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains
timeFrame: At Days 0 and 21
measure: Number of Cluster of Differentiation 4 (CD4) T-cells (Per Million CD4 T-cells) Producing at Least 2 Different Immune Markers
timeFrame: At Day 0 and 21
measure: Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least CD40L and Another Immune Marker
timeFrame: At Day 0 and 21
measure: Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IFN-γ and Another Immune Marker
timeFrame: At Day 0 and 21
measure: Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IL-2 and Another Immune Marker
timeFrame: At Day 0 and 21
measure: Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least TNF-α and Another Immune Marker
timeFrame: At Day 0 and 21
measure: Number of Cluster of Differentiation 8 (CD8) T-cells (Per Million CD8 T-cells) Expressing at Least 2 Different Immune Markers
timeFrame: At Day 0 and 21
measure: Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least CD40L and Another Immune Marker
timeFrame: At Day 0 and 21
measure: Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IFN-γ and Another Immune Marker
timeFrame: At Day 0 and 21
measure: Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IL-2 and Another Immune Marker
timeFrame: At Day 0 and 21
measure: Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least TNF-α and Another Immune Marker
timeFrame: At Day 0 and 21
Other outcomes:
Locations:
city: Clearwater
country: United States
facility: GSK Investigational Site
state: Florida
city: Coral Gables
country: United States
facility: GSK Investigational Site
state: Florida
city: Milford
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Chaska
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Somers Point
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Poughkeepsie
country: United States
facility: GSK Investigational Site
state: New York
city: Carnegie
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Erie
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Gent
country: Belgium
facility: GSK Investigational Site
city: Messkirch
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Augsburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Haag
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Hoehenkirchen-Siegertsbrunn
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Langquaid
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Ruedersdorf
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Bekkestua
country: Norway
facility: GSK Investigational Site
city: Bergen
country: Norway
facility: GSK Investigational Site
city: Elverum
country: Norway
facility: GSK Investigational Site
city: Fredrikstad
country: Norway
facility: GSK Investigational Site
city: Hamar
country: Norway
facility: GSK Investigational Site
city: Haugesund
country: Norway
facility: GSK Investigational Site
city: Skien
country: Norway
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: