A phase IIa, observer-blind, multi-country, multicentre, randomised study to evaluate the immunogenicity, safety and reactogenicity of the GlaxoSmithKline Biologicals’ quadrivalent influenza vaccine (QIV) adjuvanted with various doses of the AS03 (GSK2584786A), administered in children aged 6 to 35 months, and compared to non-adjuvanted QIV and Fluarix™. - FLU D-QIV-AS03-005
- Conditions
- Immunization against influenza A and B of healthy children aged 6 to 35 months who have not received any influenza vaccination (seasonal and pandemic)MedDRA version: 12.1 Level: LLT Classification code 10022000 Term: Influenza
- Registration Number
- EUCTR2010-020312-12-FI
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Not specified
- Target Recruitment
- 4
•Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits, available for phone contact).
•Children, male or female between, and including, 6 and 35 months of age at the time of the first vaccination.
•Written informed consent obtained from the parent(s)/LAR(s) of the subject.
•Healthy subjects as established by medical history and clinical examination before entering into the study.
•Age appropriate scheduled childhood vaccinations completed to the best of parent(s)/LAR(s) knowledge.
•Born after gestation period of 36 to 42 weeks inclusive
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
•Child in care”
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
•Prior receipt of any influenza vaccination (seasonal or pandemic) or planned administration during the study period.
•Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
•Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone >0.5 mg/kg of body weight, 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).
•A family history (parents or siblings) of congenital or hereditary immunodeficiency.
•A family history (parents or siblings) of febrile seizures or/and epilepsy
•Any known or suspected allergy to any constituent of influenza or routine paediatric vaccines, a history of severe adverse reaction to any previous vaccination; or a history of anaphylactic-type reaction to consumption of egg proteins.
•History of any progressive neurological disorders or seizures (including febrile convulsion).
•Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history or physical examination.
•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 =38.0°C on rectal setting.
?Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever might be enrolled at the discretion of the investigator.
•Administration of immunoglobulins and/or any blood products within the 3 month preceding the first dose of study vaccine or planned administration during the study period.
•Any condition which, in the opinion of the investigator, render 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