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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Influenza

Treatments

Biological: Fluarix

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00380211

IDB-200-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

660 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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)