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

Phase 3

Completed

• Conditions: Influenza

• Registration Number: NCT00380211
• Lead Sponsor: GlaxoSmithKline

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.

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-09-21
• Study First Submitted QC: 2006-09-21
• Study First Posted: 2006-09-25
• Study Completion: 2006-11
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-06
• Last Update Posted: 2016-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 660

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
21 days after vaccination: seroconversion rate, seroprotection rate,
geometric mean titer fold increase

Secondary Outcome Measures

Name	Time	Method
Immediate AEs; solicited and spontaneous AEs within 42 days of vaccination;
SAEs over the whole study period

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Burke, Virginia, United States