Last updated: 11/03/2018 11:56:37
A study for evaluation of immunogenicity and reactogenicity of Fluarix™ / Influsplit SSW® 2008/2009 in adults
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Phase III study for evaluation of immunogenicity and reactogenicity of Fluarix™ / Influsplit SSW® 2008/2009 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 2008-2009 season.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Hemagglutination inhibition (HI) antibody titer
Timeframe: At Day 0 and 21
Number of subjects with HI antibody titer above the cut-off value
Timeframe: At Day 0 and 21
Number of seroprotected subjects
Timeframe: At Day 0 and 21
Number of serconverted subjects
Timeframe: At Day 21
Serconversion factor
Timeframe: At Day 21
Seroprotection power
Timeframe: At Day 21
Secondary outcomes:
Number of subjects reporting solicited 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 21-day (Day 0-20) post-vaccination period
Interventions:
Enrollment:
120
Primary completion date:
2008-30-07
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Influenza
Product
SB218352
Collaborators
Not applicable
Study date(s)
July 2008 to July 2008
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 (drug or vaccine) other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
Inclusion and exclusion 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 (drug or vaccine) other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
- Chronic administration (defined as more than 14 days) 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 1 year 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 1 year 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
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
Study complete
Actual primary completion date
2008-30-07
Actual study completion date
2008-30-07
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.
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