Clinical trial NCT00318149: Safety Study of Four Candidate Influenza Vaccines to Prevent Influenza Disease in the Elderly Population
Official title: Demonstrate the Non-inferiority in Term of Cellular Mediated Immune Response of GSK Biologicals' Influenza Candidate Vaccines Containing Various Adjuvants Administered in Elderly Population (Aged 65 Years &Amp; Older) vs Fluarix™ (Known as Alpha-Rix™ in Belgium) Administered in Adults (18-40 Years)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-04-26
Enrollment: 425
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: As influenza vaccine efficacy is reported to be lower in elderly subjects compared to healthy adults, probably as a result of immunosenescence, there is a desire to devise ways to increase the current vaccines efficacy for this target population. Adjuvants are known to boost immune responses, thus representing one way to increase the efficacy of the current GlaxoSmithKline Fluarix™ influenza vaccine in elderly subjects. The purpose of this study is to evaluate the immunogenicity and the reactogenicity of a vaccination with four different adjuvanted GlaxoSmithKline influenza vaccines administered to elderly subjects. For immunogenicity and safety evaluations, healthy adults aged 18 to 40 years old and elderly aged 65 years and older will receive Fluarix™ and form the control groups of this trial.


Eligibility criteria: Inclusion Criteria:

* A male or female aged between 18 and 40 years or aged 65 years or older at the time of the vaccination.
* Free of obvious health problems as established by medical history and clinical examination 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 preceding the administration of the 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 six months prior to the administration of the study vaccine.
* History of confirmed influenza infection since a year from the date of previous vaccination.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
* History of hypersensitivity to vaccines.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
* Acute disease at the time of enrolment.
* Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or during the study.

Primary outcomes:
measure: Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T-cells Expressing at Least 2 Markers
timeFrame: At Day 21
Secondary outcomes:
measure: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease
timeFrame: At Day 0 and at Day 21
measure: Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease
timeFrame: At Day 90 and Day 180
measure: Number of Seroconverted Subjects Against 3 Strains of Influenza Disease
timeFrame: At Day 21
measure: Number of Seroconverted Subjects Against 3 Strains of Influenza Disease
timeFrame: At Day 90 and Day 180
measure: Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease
timeFrame: At Day 21
measure: Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease
timeFrame: At Day 90 and Day 180
measure: Number of Seroprotected Subjects Against 3 Strains of Influenza Disease
timeFrame: At Day 0 and at Day 21
measure: Number of Seroprotected Subjects Against 3 Strains of Influenza Disease
timeFrame: At Day 90 and Day 180
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
timeFrame: During the 7-day (Days 0-6) follow-up period after vaccination
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
timeFrame: During the 7-day (Days 0-6) follow-up period after vaccination
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
timeFrame: During the 21-day (Days 0-20) follow-up period after vaccination
measure: Number of Subjects With Serious Adverse Events (SAEs).
timeFrame: During the entire study period (Day 0 - Day 180)
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: