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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00380211

Enrollment

660

Registered

2006-09-25

Start date

2006-09-30

Completion date

2006-11-30

Last updated

2016-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

Thimerosal reduced content, Immunogenicity, safety, reactogenicity, Young and elderly adults, Influenza vaccine

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.

Interventions

BIOLOGICALInfluenza vaccine (A/H3N2, A/H1N1, and B strains)

BIOLOGICALFluarix

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
21 days after vaccination: seroconversion rate, seroprotection rate,	—
geometric mean titer fold increase	—

Secondary

Measure	Time frame
Immediate AEs; solicited and spontaneous AEs within 42 days of vaccination;	—
SAEs over the whole study period	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026