Primary immunization of healthy subjects aged 1 through 10 years against meningococcal disease due to serogroup A, C, W-135 or Y.
Conditions
Interventions
Product Name: MenACWY conjugate vaccine
Product Code: MenACWY-TT
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN:
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All subjects must satisfy the following criteria at study entry: • Subjects who the investigator believes that their parent or legally acceptable representative 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, 1 through 10 years of age at the time of vaccination. • Written informed consent obtained from the parent or legally acceptable representative 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/legally acceptable representative’s knowledge (however, previous meningococcal vaccination is an exclusion criterion) 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: The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study: • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the 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 vaccine dose. (For corticosteroids, this will mean prednisone =0.5 mg/kg/day or its equivalent. Inhaled and topical steroids are allowed.) • Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine(s). • Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C W and/or Y (for subjects below 6 years) or within the last five previous years (for subjects 6 years old or above). • Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C W and/or Y. • previous vaccination with tetanus toxoid containing vaccine within the last 28 days. • History of meningococcal disease due to serogroup A, C, W or Y • 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 diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., Oral temperature <37.5°C / Rectal temperature <38°C / Tympanic temperature on oral setting <37.5°C / Axillary temperature <37.5°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. Specific criteria to be checked at each study visit for the long term follow-up: • History of meningococcal serogroup A,C, W and Y disease. • Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine not planned in the protocol In case one of the two exclusion criteria above becomes applicable during the long-term follow-up, the subject will not enter the long-term follow-up of that particular year and the years that follow and the reason will be documented.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: One month after vaccination: For Subjects of two years of age and above • To evaluate the non-inferiority of the MenACWY-TT conjugate vaccine compared to the licensed Mencevax ACWY in terms of the vaccine response to MenA, MenC, MenY and MenW-135* *Response to a vaccine antigen component is defined as : - for initially seronegative subject, post vaccination rSBA titer = 1:32 - for initially seropositive subject, at least 4-fold increase in rSBA titre from pre to post vaccination For Subjects below two years of age • To evaluate the non-inferiority of the vaccine response induced by the MenACWY-TT conjugate vaccine when compared to the licensed Meningitec vaccine for N. meningitidis serogroup C as measured by serum bactericidal antibodies (rSBA). • To evaluate the immunogenicity induced by the MenACWY-TT conjugate vaccine when compared to the licensed Meningitec vaccine for N. meningitidis serogroups A, W-135, and Y as measured by rSBA. ; Secondary Objective: 1m post vacc: 1) to compare the immunogenicity of MenACWY-TT with that of Mencevax ACWY (subjects= 2y)/Meningitec (subjects < 2y). 2) To evaluate the reactogenicity of MenACWY-TT when compared to Mencevax ACWY (subjects= 2y)/Meningitec (subjects < 2y). To assess the safety profile of MenACWY-TT when compared to Mencevax ACWY (subjects= 2y)/Meningitec (subjects < 2y) in terms of any grade 3 systemic symptom 0-3d post vacc. To describe SAEs, specific AEs, and conditions prompting emergency room/ physician office visits that are not related to well-being care, vaccination, injury, or common acute illnesses and any event related to lack of vaccine efficacy up to 6 m after vaccination. 1-5 y post vaccination: to compare the persistence of the immunogenicity of MenACWY-TT with that of Mencevax ACWY (subjects= 2y)/Meningitec (subjec | — |
Countries
Finland
Outcome results
None listed