A Phase III, Open-Label, Single-Dose Study to Evaluate the Safety and Immunogenicity of Fluviral® Vaccine

A Phase III, Open-Label, Single-Dose Study to Evaluate the Safety and Immunogenicity of Fluviral® Trivalent Split Virion Influenza Vaccine (2007 - 2008 Season) in Adults Ranging in Age From 18 to 60 Years and 61 Years and Over

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00505453

Enrollment

110

Registered

2007-07-23

Start date

2007-07-31

Completion date

2007-08-31

Last updated

2016-11-04

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

Conditions

Influenza

Keywords

Influenza

Brief summary

Vaccination is currently the most effective means of controlling influenza and preventing its complications and mortality in persons at risk. Once a year, a meeting of WHO experts takes place, leading to a recommendation on the influenza A and B strains that should be used for the production of vaccine for the coming influenza season. This study is designed to test the safety/reactogenicity and the immunogenicity of the Fluviral Trivalent Split Virion Influenza Vaccine containing the influenza strains recommended for the 2007-2008 season.

Interventions

BIOLOGICALFluviral®

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Healthy male and female adults, 18 years of age and older. * Female subject of non-childbearing potential. Written informed consent obtained from subject.

Exclusion criteria

* Acute disease at the time of enrollment. * Blood pressure abnormalities. * Any immunosuppressive condition, such as HIV or cancer. * Renal impairment, hepatic dysfunction, complicated insulin-dependent diabetes mellitus. * Unstable cardiopulmonary disease requiring chronic medical therapy or associated with functional impairment. * Any demyelinating disease, including Guillain-Barré syndrome. * Alcohol consumption and/or drug abuse. * Receipt of an influenza vaccine within 9 months prior to enrollment or of any vaccines within 30 days prior to enrollment. * Any known or suspected allergy to the Fluviral vaccine.

Design outcomes

Primary

Measure	Time frame
To evaluate the immunogenicity of Fluviral influenza vaccine in adults 18 years or older	21 days after vaccination

Secondary

Measure	Time frame
Evaluate safety & reactogenicity: Solicited AEs	4 days
Evaluate safety & reactogenicity: Unsolicited AEs	21 days
Evaluate safety & reactogenicity: SAEs	entire study

Countries

Canada

Outcome results

None listed

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