Last updated: 11/03/2018 16:26:44
A study to evaluate the safety and immunogenicity of GSK Biologicals’ seasonal influenza vaccine in adults
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A phase III study for evaluation of immunogenicity and reactogenicity of Fluarix™/Influsplit SSW® 2010/2011 in people aged 18 years or above
Trial description: This study is designed to test the immunogenicity and reactogenicity of the Fluarix™/Influsplit SSW® influenza vaccine containing the influenza strains recommended for the 2010-2011 season.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Hemagglutination Inhibition (HI) Antibody Titer
Timeframe: Day 0 and Day 21
Number of Seroprotected Subjects
Timeframe: Day 0 and Day 21
Number of Seroconverted Subjects
Timeframe: Day 21
Seroconversion Factor
Timeframe: Day 21
Seroprotection Power
Timeframe: Day 21
Secondary outcomes:
Number of Subjects Reporting Solicited Local Symptoms
Timeframe: During the 4-day (Day 0-3) post-vaccination period
Number of Subjects Reporting Solicited General Symptoms
Timeframe: During the 4-day (Day 0-3) post-vaccination period
Number of Subjects Reporting Unsolicited Adverse Events (AE)
Timeframe: During the 21-day (Day 0-20) post-vaccination period
Number of Subjects Reporting Serious Adverse Events (SAE)
Timeframe: During the entire study period (From Day 0 up to Day 21)
Interventions:
Biological/vaccine: Fluarix™/Influsplit SSW®
Enrollment:
114
Observational study model:
Not applicable
Primary completion date:
2010-10-07
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Influenza
Product
SB218352
Collaborators
Not applicable
Study date(s)
June 2010 to July 2010
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
Exclusion criteria:
- 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.
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.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2010-10-07
Actual study completion date
2010-10-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
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