Estudio de fase II, aleatorizado, abierto y controlado para evaluar la seguridad e inmunogenicidad de diferentes formulaciones de una vacuna experimental frente a la gripe pandémica (formulación con virus fraccionados adyuvada en AS03) administrada con un esquema de dos dosis (intervalo de 21 días) en niños de entre 3 y 9 años de edad.A phase II, randomized, open, controlled study to evaluate the safety and immunogenicity of different formulations of a pandemic influenza vaccine candidate (split virus formulation adjuvanted with AS03) given following a two-administration schedule (21 days apart) in children between 3 and 9 years of age. - H5N1-009, H5N1-022 STG 009 cohort 2, H5N1-023 STG 009 cohort 3
- Conditions
- Inmunización de niños sanos entre 3 y 9 años de edad frente a (H5N1) influenza.
- Registration Number
- EUCTR2006-001168-22-ES
- Lead Sponsor
- GlaxoSmithKline S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 405
•Children who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
•Children aged between and including 3 and 9 years of age at the time of first vaccination.
•Written informed consent obtained from the parent or guardian of the subject.
•Healthy children as established by medical history and history-directed clinical examination before entering the study.
•Subjects who are likely to reside in the vicinity of the study center for the duration of 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
•Use of any investigational or non-registered product (drug or vaccine) other than the H5N1 vaccine candidate within 30 days prior to the enrolment in this study, or planned use during the study period.
•Administration of licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after the second vaccination, with the exception of routine childhood inoculations which cannot be delayed, but which must not be administered on the same day as the H5N1 vaccine candidate.
•Administration of the interpandemic influenza vaccine 21 days prior to Day 0 or up to Day 51.
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the enrolment in this study. (For corticosteroids, this will mean prednisone, or equivalent, <= 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
•Any chronic drug therapy to be continued during the study period, with the exception of inhalative treatment for seasonal allergies or asthma.
•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 at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. axillary temperature <37.5°C).
•Administration of immunoglubulins 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.
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