Immunogenicity and Safety Study of GSK Biologicals' Fluviral® (2008 - 2009 Season) in Adults Over 18 Years

NCT ID: NCT00718120

Last Updated: 2019-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-18
• Study Completion Date: 2008-08-09

Brief Summary

This study will evaluate the immunogenicity and safety of GSK Biologicals' Trivalent split virion influenza vaccine Fluviral for the 2008-2009 season in adults over the age of 18.

Conditions

Influenza Vaccines

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Fluviral Adult Group

Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.

Group Type: EXPERIMENTAL

Fluviral®

Intervention Type: BIOLOGICAL

One intramuscular injection into the deltoid region of the non-dominant arm

Fluviral Elderly Group

Subjects aged more than 60 years received a single dose of Fluviral® vaccine.

Group Type: EXPERIMENTAL

Fluviral®

Intervention Type: BIOLOGICAL

One intramuscular injection into the deltoid region of the non-dominant arm

Interventions

Fluviral®

One intramuscular injection into the deltoid region of the non-dominant arm

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes can and will comply with the requirements of the protocol.
• Male and female adults, 18 to 60 years of age and over 60 years of age.
• Written informed consent obtained from the subject.
• Satisfactory baseline medical assessment by history and physical examination.
• Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits.

Exclusion Criteria

• Acute disease at the time of enrollment.
• Significant acute or chronic, uncontrolled medical or psychiatric illness.
• Any confirmed or suspected immunosuppressive condition including:

• History of human immunodeficiency virus (HIV) infection,
• Cancer or treatment for cancer, within 3 years of study enrollment. Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.
• History of renal impairment.
• History of hepatic dysfunction due to hepatitis B, C or toxins including alcohol.
• Complicated insulin-dependent diabetes mellitus.
• Unstable cardiopulmonary disease requiring chronic medical therapy or associated with functional impairment.
• Presence of blood dyscrasias, including hemaglobinopathies and myelo- or lymphoproliferative disorder.
• Receipt of systemic glucocorticoids within 1 month of study enrollment, or any cytotoxic or immunosuppressive drugs within six months of study enrollment. Inhaled and topical steroids are allowed.
• A history of any demyelinating disease including Multiple Sclerosis and Guillain-Barré syndrome.
• Presence of an active neurological disorder.
• History of chronic alcohol consumption and/or drug abuse.
• Any significant disorder of coagulation that increases the risk of intramuscular injections or treatment with coumadin derivatives or heparin. Persons receiving prophylactic antiplatelet medications, e.g. low-dose aspirin, and without a clinically-apparent bleeding tendency are eligible.
• Receipt of an influenza vaccine within 6 months prior to study enrollment.
• Administration of any vaccines within 30 days prior to study enrollment or during the study period.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
• Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
• Any known or suspected allergy to any constituent of the vaccine.
• A history of severe adverse reaction to a previous influenza vaccination.
• If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for the duration of the study.
• Lactating/nursing female.
• Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Sherbrooke, Quebec, Canada

Countries

Canada

Study Documents

Document Type: Dataset Specification

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

View Document

Document Type: Informed Consent Form

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

View Document

Document Type: Study Protocol

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

View Document

Document Type: Individual Participant Data Set

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

View Document

Document Type: Annotated Case Report Form

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

View Document

Document Type: Clinical Study Report

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

View Document

Document Type: Statistical Analysis Plan

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

View Document

Related Links

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

110584

Identifier Type: -

Identifier Source: org_study_id