Clinical trial NCT00380211: Safety and Immunogenicity of FluLaval™ TR and Fluarix® (Influenza Vaccines) in Young and Older Adults
Official title: A Randomized, Double-Blind Trial Evaluating the Safety and Immunogenicity of an Influenza Vaccine With Reduced Preservative (FluLaval™ TR) and a Standard Influenza Vaccine (Fluarix®) in Subjects Between 18-60 and Over 60 Years of Age.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Thimerosal reduced content
Immunogenicity, safety, reactogenicity
Young and elderly adults
Influenza vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-09-25
Enrollment: 660
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: The purpose of this trial is to describe the immunogenicity, the safety, and tolerability of FluLaval™ TR and Fluarix®, the latter serving as active comparator. The results will be compared to a standard immune response criteria, for both young and elderly populations.

Detailed description: This randomized trial will assess the immune protection offered at Day 21 by FluLaval™ TR, Fluarix® being the comparator. In both groups, immune response will be assessed through a blood test before and 21 days following vaccination. The safety and tolerability of the study vaccine will be contrasted to the comparator vaccine over a period of 42 days following vaccination.

Eligibility criteria: Inclusion Criteria:

* Male or female adults (≥18 yrs)
* Stable health status
* Provide informed consent
* Access to direct phone service (NOT a pay phone or a common-use phone service)
* Eligible females must have a negative pregnancy test

Exclusion Criteria:

* Febrile illness (\>38.0°C oral temperature)
* High blood pressure (≥140/90 mmHg)
* Significant acute or chronic
* Uncontrolled medical or psychiatric illness within 1 month prior to vaccination
* Immunosuppressive condition (confirmed or suspected)
* Renal impairment
* Hepatic dysfunction
* Complicated insulin-dependent diabetes mellitus
* Unstable cardiopulmonary disease
* Blood dyscrasias
* Cytotoxic, immunosuppressive drug, or glucocorticoids use within 1 month of vaccination (nasal glucocorticoids allowed)
* History of demyelinating disease
* Active neurological disorder
* Significant alcohol or drug abuse
* Significant coagulation disorder (prophylactic antiplatelet medications allowed)
* Influenza vaccine administrated within 6 months prior to study vaccination
* Administration of any other vaccine from 30 days prior to the end of the study
* Use of non-registered drug within 30 days prior to study vaccination
* Receipt of immunoglobulins and/or any blood products within 3 months of study vaccination
* History or suspected allergy to previous influenza vaccine, or to any constituent of FluLaval™ TR and Fluarix®, or reaction to eggs consumption
* Pregnant or nursing female subjects
* Female subjects not protected by an acceptable contraception method (except if surgically sterile or post-menopausal)

Primary outcomes:
measure: 21 days after vaccination: seroconversion rate, seroprotection rate,
measure: geometric mean titer fold increase
Secondary outcomes:
measure: Immediate AEs; solicited and spontaneous AEs within 42 days of vaccination;
measure: SAEs over the whole study period
Other outcomes:
Locations:
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Lenexa
country: United States
facility: GSK Investigational Site
state: Kansas
city: Binghamton
country: United States
facility: GSK Investigational Site
state: New York
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: GSK Investigational Site
state: Texas
city: Burke
country: United States
facility: GSK Investigational Site
state: Virginia
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: