Phase 3
N=120
A Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix™ / Influsplit SSW® 2008/2009 in Adults
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT00706563 ↗Enrolled (actual)
120
Serious AEs
0.8%
Results posted
Aug 2009
Primary outcome: Primary: Hemagglutination Inhibition (HI) Antibody Titer — 13.6; 11.6; 165.5; 68.2 titer
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fluarix™ (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemagglutination Inhibition (HI) Antibody Titer |
13.6; 11.6; 165.5; 68.2; 7.6; 9.7 | — |
| PRIMARY Number of Subjects With HI Antibody Titer Above the Cut-off Value |
36; 35; 61; 58; 19; 23 | — |
| PRIMARY Number of Seroprotected Subjects |
15; 9; 55; 40; 5; 8 | — |
| PRIMARY Number of Serconverted Subjects |
44; 30; 44; 39; 39; 30 | — |
| PRIMARY Serconversion Factor |
12.2; 5.9; 12.0; 12.4; 7.7; 4.9 | — |
| PRIMARY Seroprotection Power |
40; 32; 42; 35; 13; 9 | — |
| SECONDARY Number of Subjects Reporting Solicited Symptoms |
3; 0; 19; 7; 36; 22 | — |
| SECONDARY Number of Subjects Reporting Unsolicited Adverse Events (AE) |
7; 6 | — |
| SECONDARY Number of Subjects Reporting Serious Adverse Events (SAE) |
1; 0 | — |
Summary
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.
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 (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
Data sourced from ClinicalTrials.gov (NCT00706563). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.