Last updated: 11/03/2018 07:45:48
Safety study of four candidate influenza vaccines to prevent influenza disease in the elderly population
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Demonstrate the non-inferiority in term of cellular mediated immune response of GSK Biologicals' influenza candidate vaccines containing various adjuvants administered in elderly population (aged 65 years & older) vs Fluarix™ (known as alpha-Rix™ in Belgium) administered in adults (18-40 years)
Trial description: As influenza vaccine efficacy is reported to be lower in elderly subjects compared to healthy adults, probably as a result of immunosenescence, there is a desire to devise ways to increase the current vaccines efficacy for this target population. Adjuvants are known to boost immune responses, thus representing one way to increase the efficacy of the current GlaxoSmithKline Fluarix™ influenza vaccine in elderly subjects. The purpose of this study is to evaluate the immunogenicity and the reactogenicity of a vaccination with four different adjuvanted GlaxoSmithKline influenza vaccines administered to elderly subjects. For immunogenicity and safety evaluations, healthy adults aged 18 to 40 years old and elderly aged 65 years and older will receive Fluarix™ and form the control groups of this trial.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Frequency of influenza-specific Cluster of Differentiation 4+ (CD4+) T-cells expressing at least 2 markers
Timeframe: At Day 21
Secondary outcomes:
Titers for serum Hemagglutination Inhibition (HI) antibodies against 3 strains of influenza disease
Timeframe: At Day 0 and at Day 21
Titers for serum HI antibodies against 3 strains of influenza disease
Timeframe: At Day 90 and Day 180
Number of seroconverted subjects against 3 strains of influenza disease
Timeframe: At Day 21
Number of seroconverted subjects against 3 strains of influenza disease
Timeframe: At Day 90 and Day 180
Seroconversion factor for Hemagglutination Inhibition (HI) antibodies against 3 strains of influenza disease
Timeframe: At Day 21
Seroconversion factor for Hemagglutination Inhibition (HI) antibodies against 3 strains of influenza disease
Timeframe: At Day 90 and Day 180
Number of seroprotected subjects against 3 strains of influenza disease
Timeframe: At Day 0 and at Day 21
Number of seroprotected subjects against 3 strains of influenza disease
Timeframe: At Day 90 and Day 180
Number of subjects with any and Grade 3 solicited local symptoms.
Timeframe: During the 7-day (Days 0-6) follow-up period after vaccination
Number of subjects with any, Grade 3 and related solicited general symptoms.
Timeframe: During the 7-day (Days 0-6) follow-up period after vaccination
Number of subjects with any, Grade 3 and related unsolicited adverse events (AEs).
Timeframe: During the 21-day (Days 0-20) follow-up period after vaccination
Number of subjects with serious adverse events (SAEs).
Timeframe: During the entire study period (Day 0 - Day 180)
Interventions:
Enrollment:
425
Primary completion date:
2006-14-05
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Influenza
Product
GSK576389A
Collaborators
Not applicable
Study date(s)
October 2005 to May 2006
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- A male or female aged between 18 and 40 years or aged 65 years or older at the time of the vaccination.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, 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 administration of the study vaccine.
Inclusion and exclusion criteria
Inclusion criteria:
- A male or female aged between 18 and 40 years or aged 65 years or older at the time of the vaccination.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Exclusion criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, 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 administration of the study vaccine.
- History of confirmed influenza infection since a year from the date of previous vaccination.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- History of hypersensitivity to vaccines.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or during 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
2006-14-05
Actual study completion date
2006-14-05
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
Participate in clinical trial
Additional information
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click hereAccess to clinical trial data by researchers
Visit website