One dose primary immunization against Neisseria meningitidis (N. meningitidis) serogroups A, C, W-135, and Y in healthy children aged 12 through 23 months
Conditions
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 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 23 months of age at the time of the first vaccination. •Written informed consent obtained from 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. •Documented three-dose primary vaccination with DTPa, hepatitis B, inactivated polio and Haemophilus influenzae type b conjugate vaccines, completed at least 180 days before administration of the first study vaccination. This will be recorded in the subject’s eCRF. 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 vaccines 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 >= 0.5 mg/kg/day prednisone or equivalent. Inhaled and topical steroids are allowed.) •Planned administration/ administration of any vaccine not foreseen by the study protocol, including measles, mumps, rubella, varicella and pneumococcal vaccines, within 30 days before the first dose of vaccine(s) and 30 days after the last dose of vaccine(s). •Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W and/or Y. •Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W and/or Y. •Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis or Haemophilus influenzae type b. •History of meningococcal disease. •Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing required). •History of reactions or allergic disease likely to be exacerbated by any component of the vaccine(s). •Major congenital defects or serious chronic illness. •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. Oral temperature <37.5°C/ Rectal temperature <38°C / Axillary temperature <37.5°C / Tympanic temperature on oral setting <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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Co-administration of MenACWY-TT and Infanrix hexa In subjects of the MenACWY-TT + Infanrix hexa and MenACWY-TT groups: To demonstrate the non-inferiority of the MenACWY-TT conjugate vaccine co-administered with combined DTPa-HBV-IPV/Hib vaccine to the MenACWY-TT conjugate vaccine given alone in terms of serum bactericidal antibodies (rSBA) for N. meningitidis serogroups A, C, W-135, and Y. In subjects of the MenACWY-TT + Infanrix hexa and Infanrix hexa groups: To demonstrate the non-inferiority of the combined DTPa-HBV-IPV/Hib vaccine co-administered with MenACWY-TT conjugate vaccine to DTPa-HBV-IPV/Hib vaccine given alone in terms of geometric mean concentrations (GMCs) of antibodies to pertussis toxoid (PT), filamentous haemagglutinin (FHA), pertactin (PRN), percentages of subjects with antibody concentrations to PRP >= 1.0µg/ml and to HBsAg >= 10mIU/ml. ;Secondary Objective: evaluate the non-inferiority of Infanrix hexa co-administered with MenACWY-TT to Infanrix hexa given alone compare the immunogenicity of MenACWY-TT co-administered with Infanrix hexa to MenACWY-TT given alone compare the immunogenicity of MenACWY-TT given 1 month after Infanrix hexa to MenACWY-TT given 1 month before Infanrix hexa compare the immunogenicity of Infanrix hexa given one month after MenACWY-TT to Infanrix hexa given one month before MenACWY-TT compare the immunogenicity of MenACWY-TT given alone to Meningitec for N. meningitidis serogroup C compare the immunogenicity of MenACWY-TT co-administered with the Infanrix hexa to Meningitec vaccine for N. meningitidis serogroup C evaluate the safety and reactogenicity of each vaccine in terms of the occurrence of solicited and unsolicited symptoms describe SAEs and specific AEs occurring up to 6 months after meningococcal vaccination;Primary end point(s): 1 month after first vaccine dose: In subjects of the MenACWY-TT + Infanrix hexa and MenACWY-TT groups: •rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers >= 1:8 I | — |
Countries
Austria, Germany, Greece
Outcome results
None listed