Evaluate Safety & Immunogenicity of GSK Bio's Influenza Vaccine GSK576389A After Repeated Vaccination in Elderly Adults - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00538473

Purpose

Since influenza vaccines are administered every year because of the frequent change in their antigenic composition, the safety and immunogenicity profile of GSK Biologicals' influenza vaccine GSK576389A will be re-evaluated after repeated vaccine administration. In this study, the subjects previously enrolled in study 107973 will receive a dose with the 2007-2008 season's formulations of Fluarix or GSK576389A. Only subjects who were previously enrolled in study 107973 (NCT00386113) are eligible for participation in this study.

Condition	Intervention	Phase
Influenza	Biological: GSK Biologicals' influenza vaccine GSK576389A Biological: Fluarix™	Phase II

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines Fluvirin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Reactogenicity and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK576389A in Elderly Adults (≥67 Years) Previously Vaccinated With the Same Candidate Vaccine. Fluarix™ Will be Used as Reference.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Occurrence, intensity, duration & relationship to vaccination of solicited local and general signs and symptoms, in each group [ Time Frame: During a 7-day follow-up period after vaccination. ] [ Designated as safety issue: Yes ]
Occurrence, intensity, duration & relationship to vaccination of unsolicited adverse events (AEs), in each group. [ Time Frame: During a 21-day follow-up period after vaccination. ] [ Designated as safety issue: Yes ]
Occurrence, intensity, duration & relationship to vaccination of medically significant conditions prompting emergency room visits, hospitalizations or physician visits & that are not routine visits for physical examination or vaccination, in each group [ Time Frame: During a 21-day follow-up period after vaccination. ] [ Designated as safety issue: Yes ]
Occurrence of serious adverse events, in each group [ Time Frame: During the entire study period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Serum Haemagglutinin Inhibition (HI) antibody titer, against each of the three vaccine strains, in each group. [ Time Frame: At Days 0 and 21 ] [ Designated as safety issue: No ]
Geometric mean titers (GMTs) of HI antibody titers , in each group. [ Time Frame: At Days 0 and 21 ] [ Designated as safety issue: No ]
Seroconversion rates, in each group. [ Time Frame: At Day 21 ] [ Designated as safety issue: No ]
Seroconversion factors, in each group. [ Time Frame: At Day 21 ] [ Designated as safety issue: No ]
Seroprotection rates, in each group. [ Time Frame: At Days 0 and 21 ] [ Designated as safety issue: No ]
Frequency of cytokine-positive CD4/CD8 cells per 10E6 in tests producing at least two different cytokines, in each group. [ Time Frame: At Days 0 and 21 ] [ Designated as safety issue: No ]
Frequency of cytokine-positive CD4/CD8 cells per 10E6 in tests producing at least CD40L and another signal molecule in each group. [ Time Frame: At Days 0 and 21 ] [ Designated as safety issue: No ]
Frequency of cytokine-positive CD4/CD8 cells per 10E6 in tests producing at least IL-2 and another signal molecule in each group. [ Time Frame: At Days 0 and 21 ] [ Designated as safety issue: No ]
Frequency of cytokine-positive CD4/CD8 cells per 10E6 in tests producing at least IFN-γ and another signal molecule in each group. [ Time Frame: At Days 0 and 21 ] [ Designated as safety issue: No ]
Frequency of cytokine-positive CD4/CD8 cells per 10E6 in tests producing at least TNF-α and another signal molecule in each group. [ Time Frame: At Days 0 and 21 ] [ Designated as safety issue: No ]
For each test, geometric mean (GM) of specific influenza CD4/CD8 T lymphocytes, in each group [ Time Frame: At Days 0 and 21 ] [ Designated as safety issue: No ]

Enrollment:	68
Study Start Date:	October 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group B: Active Comparator	Biological: Fluarix™ Single dose, intramuscular injection
Group A: Experimental	Biological: GSK Biologicals' influenza vaccine GSK576389A Single dose, intramuscular injection

Detailed Description:

This study is a year 3 revaccination study. Second year revaccination was done in study 107973 (NCT00386113). First year revaccination was done in study 104540 (NCT00318058). Primary study was study 103304.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Eligibility

Ages Eligible for Study:	67 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects who were previously vaccinated with GlaxoSmithKline Biologicals Fluarix™ or GSK576389A vaccines in the 107973 study (NCT00386113).
Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
A male or female aged >= 67 years at the time of re-vaccination.
Written informed consent obtained from the subject.
Free of an acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed examination) before entering into the study.

Exclusion Criteria:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days prior to vaccination, or planned use during the study period.
Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study.
Planned administration of a vaccine not foreseen by the study protocol up to 21 days after vaccination.
Confirmed influenza infection since the date of previous vaccination.
Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
Vaccination against influenza since January 2007 with the Northern Hemisphere 2007/2008 influenza vaccine or 2006/2007 influenza vaccine.
Administration of more than 14 days of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
History of hypersensitivity to a previous dose of influenza vaccine.
History of allergy or reactions likely to be exacerbated by any component of the vaccine(s).
Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation (medical history and medical history directed physical examination) or pre-existing laboratory screening tests.
Acute disease at the time of enrolment.
Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or planned administration during the study.
Any medical conditions in which intramuscular injections are contraindicated.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00538473

Locations

Belgium
GSK Investigational Site
Gent, Belgium, 9000

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	110223
Study First Received:	October 1, 2007
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00538473
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by GlaxoSmithKline:

GSK Bio's influenza vaccine GSK576389A
Fluarix
Influenza Infection

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections

ClinicalTrials.gov processed this record on January 16, 2009