A phase III, double-blind, randomized, study in adults aged between 18 and 60 years to assess the immunological non-inferiority of two manufacturing processes of the A/California/7/2009 (H1N1)v-like antigen adjuvanted with AS03A. - FLU D-PAN H1N1-AS03-024

• Conditions: Immunization against A/California/7/2009 (H1N1)v-like influenza in male and female subjects aged 18 to 60 years.

• Registration Number: EUCTR2009-015997-36-DE
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•All subjects must satisfy ALL the following criteria at study entry:
•A male or female aged 18 to 60 years of age at the time of the first vaccination.
•Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g. comprehension of the study requirements, ability to comprehend and comply with procedures for collection of safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits).
•Written informed consent obtained from the subject.
•Satisfactory baseline medical assessment by history and physical examination (stable health status with no exclusionary medical, including psychiatric conditions). Stable health status is defined as the absence of 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 multiple-user device (i.e., a common-use phone serving multiple rooms or apartments).
•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.
Please refer to the Glossary of Terms for the definition of menarche and 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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
•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 >= 37.5°C (99.5°F), or acute symptoms greater than mild” severity on the scheduled date of first vaccination. NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, vaccination occurs within the window specified by the protocol, and all other eligibility criteria continue to be satisfied.
•Clinically or virologically confirmed influenza infection within 6 months preceding the study start.
•Diagnosed with cancer, or treatment for cancer, within 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 excisions 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 the treatment for breast cancer and receiving long-term prophylactic tamoxifen are excepted and may enrol.
•Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
•Chronic administration (defined as more than 14 days in total) 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 >= 10 mg/day of prednisone or equivalent for persons 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 coumarin derivatives, other vitamin K antagonists 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 acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible.
•Any contraindication to intramuscular administration of the influenza vaccines.
•An acute evolving neurological disorder or history of Guillain-Barré syndrome.
•Administration of any vaccines within 30 days before vaccination.
•Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins); a history of anaphylactic-type reaction to any constituent of influenza vaccines (including egg proteins); 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