Clinical trial NCT00532298: Non-Inferiority of Various GSK Bio's Influenza Vaccine Presentations in Adults Aged 65 Years and Over
Official title: Non-Inferiority of GlaxoSmithKline Biologicals' Influenza Vaccine (GSK576389A) 1 Container Over 2 Container Presentation in Adults Aged 65 Years and Over
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: Fluarix
Influenza Infection
GSK Biologicals' influenza vaccine GSK576389A
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-09-20
Enrollment: 1596
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This observer blind study is designed to compare the immune response of GSK Biologicals' influenza vaccine GSK576389A when administered using various presentations in adults aged 65 years and older. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed description: The study contains 6 parallel groups, stratified by two age groups: 65-74 years and ≥ 75 years and by two influenza vaccination histories: no influenza vaccination in the last 3 seasons and at least one influenza vaccination in the last 3 seasons.

Eligibility criteria: Inclusion Criteria:

* 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 65 years or older at the time of the vaccination.
* 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.

Exclusion Criteria:

* 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.
* 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 Visit 2 after vaccination.
* Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
* Vaccination against influenza since January 2007 (including the Northern Hemisphere NH 2006/2007 or NH 2007/08 influenza vaccine).
* Chronic administration (defined as 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 hypersensivity to a previous dose of influenza vaccine.
* History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
* Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation 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: Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain
timeFrame: At Days 0 and 21
Secondary outcomes:
measure: HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations
timeFrame: At Days 0 and 21
measure: The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations
timeFrame: At Day 21
measure: HI Antibody Seroconversion Factors
timeFrame: At Day 21
measure: The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations
timeFrame: At Days 0 and 21
measure: Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
timeFrame: During a 7-day follow-up period (Day 0-6) after vaccination
measure: Duration of Solicited Local AEs
timeFrame: During a 7-day follow-up period (Day 0-6) after vaccination
measure: Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
timeFrame: During a 7-day follow-up period (Day 0-6) after vaccination
measure: Duration of Solicited General AEs
timeFrame: During a 7-day follow-up period (Day 0-6) after vaccination
measure: Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
timeFrame: During a 21-day follow-up period (Day 0-20) after vaccination
measure: Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
timeFrame: During a 21-day follow-up period (Day 0-20) after vaccination
measure: Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
timeFrame: During a 21-day follow-up period (Day 0-20) after vaccination
Other outcomes:
Locations:
city: Soeborg
country: Denmark
facility: GSK Investigational Site
city: Tartu
country: Estonia
facility: GSK Investigational Site
city: Bergen
country: Norway
facility: GSK Investigational Site
city: Elverum
country: Norway
facility: GSK Investigational Site
city: Hamar
country: Norway
facility: GSK Investigational Site
city: Stavanger
country: Norway
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: