A Study for Evaluation of Immunogenicity and Reactogenicity of FluarixTM / Influsplit SSW® 2009/2010 in Adults - Full Text View

Purpose

This study is designed to test the immunogenicity and reactogenicity of the FluarixTM/Influsplit SSW® influenza vaccine containing the influenza strains recommended for the 2009-2010 season.

Condition	Intervention	Phase
Seasonal Influenza	Biological: Fluarix™/Influsplit SSW®	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	A Phase III Study for Evaluation of Immunogenicity and Reactogenicity of FluarixTM / Influsplit SSW® 2009/2010 in People Aged 18 Years or Above

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Hemagglutination Inhibition (HI) Antibody Titer [ Time Frame: Day 0 and Day 21 ] [ Designated as safety issue: No ]
Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains
Number of Subjects With HI Antibody Titer Above the Cut-off Value [ Time Frame: Day 0 and Day 21 ] [ Designated as safety issue: No ]
The cut-off value assessed was ≥ 1:10 and was presented for all three vaccine influenza virus strains
Number of Seroprotected Subjects [ Time Frame: Day 0 and Day 21 ] [ Designated as safety issue: No ]
A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40
Number of Seroconverted Subjects [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
A seroconverted subject is a subject with a pre-vaccination serum HI titer < 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and a fold increase (Day 21/Day 0) ≥ 4
Seroconversion Factor [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
Seroconversion factor, defined as the fold increase in serum HI GMT post-vaccination compared to pre-vaccination (Day 0), is presented for all three vaccine influenza virus strains
Seroprotection Power [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
Seroprotection power is defined as the number of subject who had a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40

Secondary Outcome Measures:

Number of Subjects Reporting Solicited Local Symptoms [ Time Frame: During the 4-day (Day 0-3) post-vaccination period ] [ Designated as safety issue: No ]
Solicited local symptoms assessed include ecchymosis, induration, pain, redness, and swelling.
Number of Subjects Reporting Solicited General Symptoms [ Time Frame: During the 4-day (Day 0-3) post-vaccination period ] [ Designated as safety issue: No ]
Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, shivering, sweating, and fever
Number of Subjects Reporting Unsolicited Adverse Events (AE) [ Time Frame: During the 21-day (Day 0-20) post-vaccination period ] [ Designated as safety issue: No ]
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Number of Subjects Reporting Serious Adverse Events (SAE) [ Time Frame: During the entire study period ] [ Designated as safety issue: No ]
An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

Enrollment:	118
Study Start Date:	June 2009
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Fluarix Adult Group Subjects who are 18-60 years of age received one dose of Fluarix™	Biological: Fluarix™/Influsplit SSW® single intramuscular dose on Day 0
Experimental: Fluarix Elderly Group Subjects who are > 60 years of age received one dose of Fluarix™	Biological: Fluarix™/Influsplit SSW® single intramuscular dose on Day 0

Eligibility

Ages Eligible for Study:	18 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 aged 18 years or above at the time of the vaccination.
Written informed consent obtained from the subject.
Healthy subjects or with well-controlled chronic diseases as established by medical history and clinical examination before entering into the study.
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 2 months after completion of the vaccination series.

Exclusion Criteria:

Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
Administration of an influenza vaccine within 6 months preceding the study start.
Administration of an influenza vaccine other than the study vaccine during the entire study
Clinically or virologically confirmed influenza infection within 6 months preceding the study start
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Acute disease at the time of enrolment.
Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Not stabilized or clinically serious chronic underlying disease.
Lactating female.
History of chronic alcohol consumption and/or drug abuse.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00920374

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00920374 History of Changes
Other Study ID Numbers:	113018
Study First Received:	June 12, 2009
Results First Received:	April 22, 2010
Last Updated:	March 14, 2013
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by GlaxoSmithKline:

Influenza

Additional relevant MeSH terms:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections

Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013