Non-Inferiority Study of GSK Biologicals' Influenza Vaccine GSK576389A Using Different Formulations - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00633074

Purpose

The purpose of this study is to show the non-inferiority of different formulations of GlaxoSmithKline Biologicials' influenza vaccine.

Condition	Intervention	Phase
Influenza Infection	Biological: GSK Bio's influenza vaccine GSK576389A	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	Non-Inferiority Study of GlaxoSmithKline Biologicals' Influenza Vaccine GSK576389A Using Different Formulations.

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Fluvirin Influenza Vaccines

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Serum haemagglutination-inhibition (HI) antibody titer [ Time Frame: Days 0 and 21 ] [ Designated as safety issue: No ]
GMTs of HI antibody titers. [ Time Frame: Days 0 and 21 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Serum haemagglutination-inhibition (HI) antibody titer. [ Time Frame: Days 0 and 21 ] [ Designated as safety issue: No ]
Seropositivity rates [ Time Frame: Days 0 and 21 ] [ Designated as safety issue: No ]
Seroconversion rates. [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
Seroconversion factors. [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
Seroprotection rates [ Time Frame: Days 0 and 21 ] [ Designated as safety issue: No ]
Occurrence, intensity, duration and relationship to vaccination of solicited local and general signs and symptoms. [ Time Frame: During a 7-day period after vaccination. ] [ Designated as safety issue: Yes ]
Occurrence, intensity, duration and relationship to vaccination of unsolicited AEs. [ Time Frame: During a 21-day period after vaccination. ] [ Designated as safety issue: Yes ]
Occurrence, intensity, duration and 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. [ Time Frame: During a 21-day period after vaccination. ] [ Designated as safety issue: Yes ]
Occurrence and relationship to vaccination of serious adverse events [ Time Frame: During the entire study period (up to Day 21). ] [ Designated as safety issue: Yes ]

Enrollment:	834
Study Start Date:	March 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Biological: GSK Bio's influenza vaccine GSK576389A IM administration, 1 dose
B: Experimental	Biological: GSK Bio's influenza vaccine GSK576389A IM administration, 1 dose

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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 65 years of age or older at the time of 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:

Suspected (based on clinical symptoms) or confirmed (based on laboratory results) influenza infection within the last 6 months.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, 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.
Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
Previous vaccination against influenza with any seasonal vaccine since July 2007.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
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) including egg and chicken protein.
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 dose of study vaccine or planned administration during the study period.
Any medical conditions in which IM injections are contraindicated

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00633074

Locations

Estonia
GSK Investigational Site
Tartu, Estonia, 50417
GSK Investigational Site
Saku, Estonia, 75501
GSK Investigational Site
Tallinn, Estonia, 13419

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	111454
Study First Received:	February 29, 2008
Last Updated:	May 21, 2009
ClinicalTrials.gov Identifier:	NCT00633074 History of Changes
Health Authority:	Estonia: The State Agency of Medicine

Keywords provided by GlaxoSmithKline:

Influenza

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

Virus Diseases
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections

Influenza, Human
Orthomyxoviridae Infections
Infection

ClinicalTrials.gov processed this record on September 10, 2009