Influenza Clinical Trial
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
NCT number | NCT00920374 |
Other study ID # | 113018 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | June 16, 2009 |
Est. completion date | July 8, 2009 |
Verified date | October 2016 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 118 |
Est. completion date | July 8, 2009 |
Est. primary completion date | July 8, 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Germany | GSK Investigational Site | Dresden | Sachsen |
Germany | GSK Investigational Site | Dresden | Sachsen |
Germany | GSK Investigational Site | Dresden | Sachsen |
Germany | GSK Investigational Site | Dresden | Sachsen |
Germany | GSK Investigational Site | Freital | Sachsen |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hemagglutination Inhibition (HI) Antibody Titer | Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains | Day 0 and Day 21 | |
Primary | Number of Subjects With HI Antibody Titer Above the Cut-off Value | The cut-off value assessed was = 1:10 and was presented for all three vaccine influenza virus strains | Day 0 and Day 21 | |
Primary | Number of Seroprotected Subjects | A seroprotected subject is a subject with a serum HI antibody titer = 1:40 | Day 0 and Day 21 | |
Primary | Number of Seroconverted Subjects | 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 | Day 21 | |
Primary | Seroconversion Factor | 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 | Day 21 | |
Primary | Seroprotection Power | Seroprotection power is defined as the number of subject who had a pre-vaccination titer < 1:40 and a post-vaccination titer = 1:40 | Day 21 | |
Secondary | Number of Subjects Reporting Solicited Local Symptoms | Solicited local symptoms assessed include ecchymosis, induration, pain, redness, and swelling. | During the 4-day (Day 0-3) post-vaccination period | |
Secondary | Number of Subjects Reporting Solicited General Symptoms | Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, shivering, sweating, and fever | During the 4-day (Day 0-3) post-vaccination period | |
Secondary | Number of Subjects Reporting Unsolicited Adverse Events (AE) | 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. | During the 21-day (Day 0-20) post-vaccination period | |
Secondary | Number of Subjects Reporting Serious Adverse Events (SAE) | 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. | During the entire study period |
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