A phase III, open, randomized, trial to evaluate the immunogenicity and safety of a single or two-dose schedule of the A/California/7/2009 (H1N1)v-like candidate vaccine manufactured in Dresden adjuvanted with AS03A, in adults aged 18 years and above - FLU D-PAN H1N1-008
- Conditions
- Immunization against A/California/7/2009 (H1N1)v-like influenza in male and female subjects aged 18 years and above.
- Registration Number
- EUCTR2009-013837-92-BE
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 240
•A male or female aged 18 years or above at the time of the first vaccination.
•Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
•Written informed consent obtained from the subject.
•Satisfactory baseline medical assessment by history and physical examination. Stable health status is defined as the absence of a health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within one month prior to enrolment.
•Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device.
•Female subjects of non-childbearing potential may be enrolled in the study.
•Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
•Female subjects of childbearing potential may be enrolled in the study, if the subject:
-has practiced adequate contraception for 30 days prior to vaccination, and
-has a negative pregnancy test on the day of vaccination, and
-has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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 other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period. Potential subjects in the follow-up phase of a prior investigational study may be enrolled if the investigator’s judgment is that it will have no effect on safety, reactogenicity, or immunogenicity endpoints in this study, and that it does not violate the protocol requirements of the prior trial.
•Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
•Presence of an axillary temperature = 37.5ºC, or acute symptoms greater than mild” severity on the scheduled date of first vaccination.
•Diagnosed with cancer, or treatment for cancer, within the past 3 years.
-Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.
-Persons with a history of histological-confirmed basal cell carcinoma of the skin successfully treated with local excision only are excepted and may enrol within 3 years of diagnosis, but other histological types of skin cancer require a 3 year untreated and disease-free window as above.
-Women who are disease-free 3 years or more after treatment for breast cancer and receiving long-term prophylactic hormonal therapy are excepted and may enrol.
•Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus infection.
•Chronic administration of immunosuppressants or other immune modifying drugs within 6 months of study enrolment or planned administration during the study period. For corticosteroids, this will mean a dose equivalent to 20 mg/day of prednisone when administered for > 2 weeks. Inhaled and topical steroids are allowed.
•Receipt of any immunoglobulins and/or any blood products within 3 months of study enrolment or planned administration of any of these products during the study period.
•Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency, are eligible.
•An acute evolving neurological disorder or history of Guillain-Barré syndrome.
•Clinically or virologically confirmed influenza infection within 6 months preceding the study start.
•Administration of any vaccines within 30 days before vaccination.
•Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
•Pregnant or lactating female
•Female planning to become pregnant or planning to discontinue contraceptive precautions.
•Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method