Safety and Immunogenicity of FluLaval™ TR and Fluarix® (Influenza Vaccines) in Young and Older Adults
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Influenza
Intervention: Influenza vaccine (A/H3N2, A/H1N1, and B strains) (Biological); Fluarix (Biological)
Phase: Phase 3
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
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 design: Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 21 days after vaccination: seroconversion rate, seroprotection rate,geometric mean titer fold increase
Secondary outcome: Immediate AEs; solicited and spontaneous AEs within 42 days of vaccination;SAEs over the whole study period
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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)
Locations and Contacts
GSK Clinical Trials Call Center, Miami, Florida 33173, United States
GSK Clinical Trials Call Center, Lenexa, Kansas 66219, United States
GSK Clinical Trials Call Center, Endwell, New York 13760, United States
GSK Clinical Trials Call Center, Austin, Texas 78705, United States
GSK Clinical Trials Call Center, Burke, Virginia 22015, United States
Additional Information
Starting date: September 2006
Last updated: January 25, 2007
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