Clinical trial NCT00538473: Evaluate Safety and Immunogenicity of GSK Bio's Influenza Vaccine GSK576389A After Repeated Vaccination in Elderly Adults
Official title: Reactogenicity and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK576389A in Elderly Adults (≥67 Years) Previously Vaccinated With the Same Candidate Vaccine. Fluarix™ Will be Used as Reference.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: GSK Bio's influenza vaccine GSK576389A
Influenza Infection
Fluarix
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-10-02
Enrollment: 68
Sex: ALL
Minimum age (years): 67
Standard ages: 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 study, the subjects previously enrolled in study 107973 will receive a dose with the 2007-2008 season's formulations of Fluarix or GSK576389A. Only subjects who were previously enrolled in study 107973 (NCT00386113) are eligible for participation in this study.

Detailed description: This study is a year 3 revaccination study. Second year revaccination was done in study 107973 (NCT00386113). First year revaccination was done in study 104540 (NCT00318058). Primary study was study 103304.

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

Eligibility criteria: Inclusion Criteria:

* Subjects who were previously vaccinated with GlaxoSmithKline Biologicals Fluarix™ or GSK576389A vaccines in the 107973 study (NCT00386113).
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
* A male or female aged \>= 67 years at the time of re-vaccination.
* Written informed consent obtained from the subject.
* Free of an acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed examination) before entering into the study.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days prior to vaccination, or planned use during the study period.
* 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 21 days after vaccination.
* Confirmed influenza infection since the date of previous vaccination.
* Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
* Vaccination against influenza since January 2007 with the Northern Hemisphere 2007/2008 influenza vaccine or 2006/2007 influenza vaccine.
* Administration of more than 14 days of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine.
* 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 clinical evaluation (medical history and medical history directed 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 administration of the study vaccine or planned administration during the study.
* Any medical conditions in which intramuscular injections are contraindicated.

Primary outcomes:
measure: Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
timeFrame: During a 7-day follow-up period after vaccination
measure: Duration of Solicited Local Symptoms
timeFrame: During a 7-day follow-up period after vaccination
measure: Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During a 7-day follow-up period after vaccination
measure: Duration of Solicited General Symptoms
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
measure: Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
timeFrame: During a 21-day follow-up period after vaccination
measure: Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
timeFrame: Throughout the entire study (up to Day 21)
Secondary outcomes:
measure: Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains
timeFrame: At Days 0 and 21
measure: Number of Subjects Seropositive for HI Antibodies 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 (SCFs) 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 Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
timeFrame: At Days 0 and 21
measure: Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
timeFrame: At Days 0 and 21
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: