Primary immunization of healthy children aged 12-14 months and 3-5 years against meningococcal serogroups A, C, W-135 and Y diseases.
Conditions
Interventions
Product Name: MenACWY conjugate vaccine
Product Code: MenACWY-TT
Pharmaceutical Form: Powder and solvent for solution for injection
Concentration unit: µg microgram(s)
Concentration type: equal
Concen
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects 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. - A male or female between, and including, 12 and 14 months or 3 and 5 years (36 to 60 months) of age at the time of the first vaccination - Written informed consent obtained from the the parent or guardian of the subject. - Free of obvious health problems as established by medical history and clinical examination before entering into the study. - Previously completed routine childhood vaccinations to the best of his/her parents’/guardians’ knowledge. For pertussis vaccination, the children aged 12-14 months should have been vaccinated with an acellular pertussis vaccine. 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(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. - Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.) - Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the first dose of vaccine and up to one month after administration of each study vaccine dose with the exception of oral polio vaccine (OPV). - Previous vaccination against meningococcal serogroup A, C, W-135 or Y disease. - Administration of a H. influenzae type b, diphtheria or tetanus vaccine within 3 months before the first dose of vaccine. - For subjects aged 12-14 months at enrolment, a DTPa/Hib containing booster vaccination, in the second year of life: these booster vaccines will be given at Visit 2. - History of meningococcal serogroup A, C, W-135 or Y disease. - Known exposure to meningococcal serogroup A, C, W-135 or Y disease within the previous year. - Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. - A family history of congenital or hereditary immunodeficiency. - History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. - Major congenital defects or serious chronic illness. - History of any neurologic 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 / Rectal temperature <38°C) - Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Based on the immune response induced one month post vaccination, to select the best of four different formulations of GSK Biologicals’ new generations MenACWY-TT conjugate vaccine when given as one single dose to healthy children aged 12-14 months and 3-5 years. ;Secondary Objective: Evaluate immune response induced by 4 formulations MenACWY-TT or control (incl. persistence 15 months after priming for group with selected dose and control) given as 1 dose to healthy children aged 12-14 months (control MENINGITEC™) or 3-5 years (control MENCEVAX ACWY) Evaluate immune memory by giving 1/5 dose MENCEVAX ACWY 15 months after priming, in subjects primed with selected formulation or MENINGITEC™ aged 12-14 months. Evaluate safety/reactogenicity induced by 4 formulations of MenACWY-TT or control given as 1 dose in subjects aged 12-14 months (control MENINGITEC™) or 3-5 years (control MENCEVAX ACWY). In the subjects primed at 12-14 months of age: - Evaluate safety/reactogenicity elicited by a booster dose of a DTPa/Hib containing vaccine given 1 month after MenACWY-TT or MENINGITEC™. Evaluate safety/reactogenicity induced by 1/5 dose MENCEVAX ACWY given to subjects primed 15 months before (age 12-14 months) with selected formulation of MenACWY-TT or MENINGITEC™. ;Primary end point(s): One month after the first vaccine dose, in all subjects: Percentage (%) of SBA-MenA, SBA-MenC, SBA-MenW-135 and SBA-MenY responders (A responder is defined as a subject having a greater than or equal to a 4-fold increase in SBA titer from pre to post vaccination) | — |
Countries
Germany
Outcome results
None listed