Back to results

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

Primary Purpose

Influenza

Status

Completed

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Fluviral®

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

GSK Investigational Site
GSK Investigational Site

Outcomes

Primary Outcome Measures

To evaluate the immunogenicity of Fluviral influenza vaccine in adults 18 years or older

Secondary Outcome Measures

Evaluate safety & reactogenicity: Solicited AEs

Evaluate safety & reactogenicity: Unsolicited AEs

Evaluate safety & reactogenicity: SAEs

Full Information

NCT ID

NCT00505453

First Posted

July 20, 2007

Last Updated

November 3, 2016

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00505453

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

Influenza

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

110 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

Fluviral®

Primary Outcome Measure Information:

Title

To evaluate the immunogenicity of Fluviral influenza vaccine in adults 18 years or older

Time Frame

21 days after vaccination

Secondary Outcome Measure Information:

Title

Evaluate safety & reactogenicity: Solicited AEs

Time Frame

4 days

Title

Evaluate safety & reactogenicity: Unsolicited AEs

Time Frame

21 days

Title

Evaluate safety & reactogenicity: SAEs

Time Frame

entire study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 1Z1

Country

Canada

Facility Name

GSK Investigational Site

City

Quebec

ZIP/Postal Code

G1W 4R4

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Links:

URL

https://www.clinicalstudydatarequest.com

Description

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

Available IPD and Supporting Information:

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110502

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Annotated Case Report Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110502

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110502

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110502

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110502

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110502

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110502

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

We'll reach out to this number within 24 hrs