A phase III, randomised, observer-blind, multicentre study to evaluate the immunogenicity and safety of a 2-dose vaccination with the new process manufactured adjuvanted pandemic H1N1 influenza candidate vaccine in children aged 3 to 9 years old. - FLU D-PAN H1N1-AS03-025

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits, be available for telephone/fax contacts).
Children, male or female, aged between 3 and 9 years at the time of first study vaccination.
Written informed consent obtained from the parent(s) or LAR(s) of the subject.
Healthy children, as established by medical history and clinical examination when entering the study.

Are the trial subjects under 18? yes
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) 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.
Clinically or virologically confirmed influenza infection within six months preceding the study start.
Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
Have received any seasonal flu vaccine since last year.
Previous administration of any H1N1 A/California-like vaccine.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period. For corticosteroids, this will mean prednisone = 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by 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 vaccines such as egg protein or thiomersal.
History of any neurological disorders or seizures.
Acute disease and/or fever at the time of enrolment:
Fever is defined as temperature >= 37.5°C on oral, axillary or tympanic setting, or >= 38°C on rectal setting.
Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
Any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study.
Child in Care.