Observer-blind, Post-Marketing Study to Compare the Safety and Immunogenicity of Fluviral® Trivalent Split Virion Influenza Vaccine (2007-2008 Season) Made With New vs. Aged Bulk Material, in Adults Ranging in Age From 18 to 60 Years

GlaxoSmithKline1 site in 1 country1,000 target enrollmentDecember 14, 2007

ConditionsInfluenza Vaccines

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Influenza Vaccines
Sponsor: GlaxoSmithKline
Enrollment: 1000
Locations: 1
Primary Endpoint: Geometric Mean Titers (GMTs) of Anti-H3 and B Strains
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 World Health Organization (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. For the strains which do not change from the previous year, the vaccine can be formulated from the old mono bulk from the previous year.

Bulks as old as 12 months may be blended to make trivalent inactivated vaccine (TIV) under the current Canadian and US licenses. This study is conducted to evaluate safety and immunogenicity of Fluviral vaccines made with the aged bulk material compared with the new bulk material. This protocol posting has been updated in order to comply with the FDA Amendment Act, Sept 2007.

Registry

clinicaltrials.gov

Start Date

December 14, 2007

End Date

January 14, 2008

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
•Male and female adults, 18 to 60 years.
•Written informed consent obtained from the subject.
•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.

Exclusion Criteria

•Acute disease at the time of enrollment.
•Any confirmed or suspected immunosuppressive condition
•Presence of blood dyscrasias, including hemaglobinopathies and myelo- or lymphoproliferative disorder.
•Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
•A history of any demyelinating disease including Guillain-Barré syndrome.
•Presence of an active neurological disorder.
•Any significant disorder of coagulation that increases the risk of intramuscular injections or treatment with coumadin derivatives or heparin.
•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.

Outcomes

Primary Outcomes

Geometric Mean Titers (GMTs) of Anti-H3 and B Strains

Time Frame: At Day 21

GMTs for H1 strain is addressed as a secondary endpoint

Secondary Outcomes

Geometric Mean Titers (GMTs) of the H1 Strain and the GMT of the H3 and B Strains(At Days 0 and 21)
Number of Participants Who Seroconverted.(At Day 21.)
Number of Seroprotected Participants.(At Days 0 and 21)
Seroconversion Factors Defined as the Fold Increase in Serum HI GMTs Post-vaccination for Influenza Antigen H1N1(At Day 21 compared to Day 0)
The Fold Increase in Anti-HI GMTs for Influenza Antigens H3 and B(At Day 21 compared to Day 0)
Number of Participants Reporting Solicited Local Symptoms(During the 4-day follow up period following vaccination.)
Number of Participants Reporting Solicited General Symptoms(During the 4-day period following each vaccination.)
Number of Participants Reporting Unsolicited Adverse Events (AE).(During the 21-day period following each vaccination.)
Number of Participants Reporting Serious Adverse Events (SAE)(Within 21 days after vaccination)