A phase II, open, controlled study to evaluate the reactogenicity and the immunogenicity of GlaxoSmithKline Biologicals AS25 adjuvanted influenza vaccine (FluAS25) in elderly adults previously vaccinated in FluAS25-002 clinical trial with the same candidate vaccine. Fluarix™ will be used as a reference - FluAS25-014
- Conditions
- Immunisation against influenza disease in an elderly population aged over 65 years
- Registration Number
- EUCTR2006-003237-32-BE
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
- Written informed consent obtained from the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
In the FluAS25 group, all subjects must satisfy the following criteria at study entry:
- A male or female aged 67 years or above at the time of the revaccination, who previously received FluAS25 during the FluAS25-002 clinical trial.
In the Fluarix groups, all subjects must satisfy the following criteria at study entry:
- A male or female aged over 65 years at the time of revaccination; who previously received Fluarix during the FluAS25-002 clinical trial.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- 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. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
- History of confirmed influenza infection since the date of previous vaccination.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- History of hypersensivity to a previous dose of influenza vaccine.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine including egg, chicken protein, formaldehyde, thiomersal, gentamicin sulfate or sodium deoxycholate.
- Acute or chronic 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 vaccination or planned administration during the study period.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the safety and reactogenicity of repeated vaccination with FluAS25, during 21 days following the intramuscular administration of the vaccine. Fluarix will be used as reference;Secondary Objective: To evaluate the humoral immune response (anti-haemagglutinin antibody titres), cell-mediated immune response (production of IFN, IL-2, CD40L, and TNF) and anti-MPL antibody titres 21 days after revaccination with FluAS25. Fluarix will be used as reference.;Primary end point(s): - Percentage, intensity and relationship to vaccination of solicited local and general signs and symptoms during a 7 day follow-up period (i.e. day of vaccination and 6 subsequent days) after vaccination and overall. <br>- Percentage, intensity and relationship to vaccination of unsolicited local and general signs and symptoms during a 21 day follow-up period (i.e. day of vaccination and 20 subsequent days) after vaccination and overall.<br>- Occurrence of serious adverse events during the entire study period<br>
- Secondary Outcome Measures
Name Time Method