A phase III, open, non-randomized, trial to evaluate the immunogenicity and safety of a 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 H1N1-022

GlaxoSmithKline Biologicals0 sites300 target enrollmentSeptember 4, 2009

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: GlaxoSmithKline Biologicals
Enrollment: 300
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 4, 2009

End Date

April 30, 2010

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GlaxoSmithKline Biologicals

Eligibility Criteria

Inclusion Criteria

•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 (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 or psychiatric conditions). 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 (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

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. Potential subjects in the follow\-up (i.e., no treatment) 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. 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.
•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 (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 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.