A Phase II, open (partially double-blind), randomized, controlled dose-range study to evaluate the immunogenicity, reactogenicity and safety of four different formulations of GlaxoSmithKline (GSK) Biologicals’ new generations meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine versus MENINGITEC™ or MENCEVAX™ ACWY when given as one dose to children aged 12 to 14 months and 3 to 5 years old. - MenACWY-TT-013, 014 BST:013
- Conditions
- Primary immunization of healthy children aged 12-14 months and 3-5 years against meningococcal serogroups A, C, W-135 and Y diseases.
- Registration Number
- EUCTR2005-001288-73-AT
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 500
- 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
- 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.
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