Safety and Immunogenicity of FluLaval™ TR and Fluarix® (Influenza Vaccines) in Young and Older Adults

Influenza Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00380211
• Other study ID #: IDB-200-001
• Status: Completed
• Phase: Phase 3
• First received: September 21, 2006
• Last updated: October 6, 2016
• Start date: September 2006
• Est. completion date: November 2006

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 660
• Est. completion date: November 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Influenza vaccine (A/H3N2, A/H1N1, and B strains)

• Fluarix

Locations

Country	Name	City	State
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Binghamton	New York
United States	GSK Investigational Site	Burke	Virginia
United States	GSK Investigational Site	Fort Worth	Texas
United States	GSK Investigational Site	Lenexa	Kansas
United States	GSK Investigational Site	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	21 days after vaccination: seroconversion rate, seroprotection rate,
Primary	geometric mean titer fold increase
Secondary	Immediate AEs; solicited and spontaneous AEs within 42 days of vaccination;
Secondary	SAEs over the whole study period

External Links

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