Clinical trial NCT00920374: A Study for Evaluation of Immunogenicity and Reactogenicity of FluarixTM / Influsplit SSW® 2009/2010 in Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Influenza
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-06-15
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Hemagglutination Inhibition (HI) Antibody Titer
timeFrame: Day 0 and Day 21
measure: Number of Subjects With HI Antibody Titer Above the Cut-off Value
timeFrame: Day 0 and Day 21
measure: Number of Seroprotected Subjects
timeFrame: Day 0 and Day 21
measure: Number of Seroconverted Subjects
timeFrame: Day 21
measure: Seroconversion Factor
timeFrame: Day 21
measure: Seroprotection Power
timeFrame: Day 21
Secondary outcomes:
measure: Number of Subjects Reporting Solicited Local Symptoms
timeFrame: During the 4-day (Day 0-3) post-vaccination period
measure: Number of Subjects Reporting Solicited General Symptoms
timeFrame: During the 4-day (Day 0-3) post-vaccination period
measure: Number of Subjects Reporting Unsolicited Adverse Events (AE)
timeFrame: During the 21-day (Day 0-20) post-vaccination period
measure: Number of Subjects Reporting Serious Adverse Events (SAE)
timeFrame: During the entire study period
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Freital
country: Germany
facility: GSK Investigational Site
state: Sachsen
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: