Immunisation of healthy children aged 3 years to 9 years against novel H1N1 influenza of pandemic potential.
Conditions
Interventions
Product Name: GlaxoSmithKline (GSK) Biologicals’ A/California/7/2009 (H1N1)v-like vaccine adjuvanted with AS03A
Product Code: GSK2340272A
Pharmaceutical Form: Emulsion for injection
INN or Proposed IN
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether the humoral immune response of the 3.75 µg dosage with AS03A H1N1 candidate vaccine meets or exceeds the CHMP criteria at 21 days post-dose 2 vaccination. To evaluate whether the humoral immune response of the 1.9 µg dosage with AS03B H1N1 candidate vaccine meets or exceeds the CHMP criteria at 21 days post-dose 2 vaccination.;Secondary Objective: Evaluate immunogenicity in terms of HI antibodies at 21 days after each vaccination in all subjects and per each age strata (3-5 years; 6-9 years). Evaluate immunogenicity in terms of neutralising antibodies at 21 days after each vaccination per each age strata (3-5 years; 6-9 years). Evaluation of persistence up to 6 months after last vaccine dose. To evaluate, after each vaccination, the safety and reactogenicity of the H1N1 candidate vaccine in terms of 7-day solicited local and general symptoms, 21 day post-dose 1, and post-dose 2 unsolicited adverse events (AEs). To describe medically attended visits (MAEs), adverse events of specific interest (AESIs)/potentially immune mediated disease (pIMDs), and serious adverse events (SAEs) during the whole study period. ;Primary end point(s): For the humoral immune response in terms of vaccine H1N1 HI antibodies against A/California/7/2009 (H1N1)v-like virus, the following parameters will be calculated with 95% CIs: Observed variable H1N1 HI antibodies at Day 42 Derived variables: GMTs and seropositivity rates of H1N1 HI antibodies at Day 42 SCR at Day 42 SPR at Day 42 GMFR at Day 42 | — |
Countries
Czech Republic
Outcome results
None listed