MedDataX Logo

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

NCT ID: NCT00505453

Last Updated: 2016-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2007-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Influenza

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Influenza

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fluviral®

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

Québec, Quebec, Canada

Site Status

GSK Investigational Site

Sherbrooke, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.

Document Type: Study Protocol

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Dataset Specification

View Document

Document Type: Clinical Study Report

View Document

Document Type: Informed Consent Form

View Document

Document Type: Individual Participant Data Set

View Document

Related Links

Access external resources that provide additional context or updates about the study.

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

110502

Identifier Type: -

Identifier Source: org_study_id