Invasive disease caused by Neisseria meningitidis serogroups A, C W-135 and Y MedDRA version: 18.0 Level: LLT Classification code 10028910 Term: Neisseria meningitides meningitis System Organ Class: 100000004862 MedDRA version: 18.0 Level: LLT Classification code 10028911 Term: Neisseria meningitidis infection NOS System Organ Class: 100000004862
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All subjects must satisfy the following criteria for the per-sistence phase of the study entry: •A male or female toddler who was vaccinated 1, 3 or 5 years ago with the last dose of MenACWY-TT in study with NCT number=00471081. •Written informed consent obtained from parents/guardian of the subject. •Healthy subjects as established by medical history before entering into the study. •Having completed the active phase of the vaccination study with NCT number=00471081 (i.e., not withdrawn, had received all planned doses of study vaccines, provided a post-vaccination blood sample after the final dose). All subjects must meet the following criteria prior to receiving the booster vaccination: •Written informed consent obtained from parents/guardian of the subject. •Subjects who can and will comply with the requirements of the protocol. •Subjects who provide a blood sample 5 years after last vaccination in study with NCT number=00471081. Are the trial subjects under 18? yes Number of subjects for this age range: 387 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: Exclusion criteria for persistence study entry •Use of any investigational or non-registered product (drug or vaccine) within 30 days of each persistence timepoint. •Vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, B, C, W-135, and/or Y outside of study with NCT number=00471081. •History of any meningococcal disease due to serogroup A, B, C, W-135, or Y. •Any confirmed or suspected immunosuppressive or im-munodeficiency condition based on medical history and physical examination (no laboratory testing is required). •Administration of immunoglobulins and/or any blood products within the three months preceding each persistence timepoint. •Concurrently participating in another clinical study within 30 days of each persistence timepoint, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). •Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy. •Subjects withdrew consent to be contacted for follow-up studies. Exclusion criteria for booster vaccination at year 5 study entry (to be checked at Year 5) •Subjects who were enrolled in the Kaiser Healthcare system in study with NCT number=00471081, but are no longer enrolled. •Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the booster vaccina-tion, 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 booster vaccination. (For corticosteroids, this will mean prednisone, or equivalent, = 0.5 mg/kg/day. Inhaled and topical steroids are allowed). •Vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, B, C, W-135, and/or Y outside of study with NCT number=00471081. •History of any meningococcal disease due to serogroup A, B, C, W-135, or Y. •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history (no laboratory testing is required). •Administration of immunoglobulins and/or any blood products within the three months preceding the booster vaccination or planned administration during the study period. •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). •Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy. •Subjects withdrew consent to be contacted for follow-up studies. •Hypersensitivity to latex. •Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine(s) with the exception of any licensed inactivated influenza vaccine (live attenuated influenza vaccine is not allowed). •Previous vaccination with tetanus and diphtheria toxoids within the last month (i.e., Tdap, Td, and TT-containing vaccine). •A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated. •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 neurological disorders or seizures. •Acute disease at the time of vaccination. (Acute disease is defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To evaluate the long-term persistence of the immunogenicity induced by one or two doses of MenACWY-TT vaccine administered at 12 months or 9 and 12 months of age in terms of the percentage of subjects with N. meningitidis serogroup A (MenA), N. meningitidis serogroup C (MenC), N. meningitidis serogroup W-135 (MenW-135), and N. meningitidis serogroup Y (MenY) antibody titers >= 1:8 as measured by a serum bactericidal assay using human complement (hSBA). ;Secondary Objective: •long-term persistence of MenACWY-TT in all subjects with respect to the percentage of subjects with hSBA-MenA/C/W-135/Y titers = 1:4 and GMTs and rSBA-MenA/C/W-135/Y titers. at Years 1, 3 and 5 •long-term persistence of MenACWY-TT vaccine in all subjects with respect to ELISA at Year 1 only. One month post-booster and post-primary (naïve control group) vaccination with MenACWY-TT. •immunogenicity of a booster and a primary vaccination of MenACWY-TT with respect to the percent of subjects with hSBA-MenA/C/W-135/Y titers = 1:4, = 1:8 and GMTs and rSBA-MenA/C/W-135/Y titers. •immunogenicity of a booster and a primary vaccination of MenACWY-TT with respect to the percentage of subjects with hSBA-MenA/C/W-135/Y and rSBA-MenA/C/W-135/Y vaccine response •To evaluate the safety of MenACWY-TT with respect to: -Local and general solicited symptoms -Unsolicited serious and non-serious adverse events -Serious adverse events and new onset of chronic illness(es) ;Primary end point(s): Meningococcal hSBA antibody titers;Timepoint(s) of evaluation of this end point: One year, three years, and five years after primary vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Meningococcal hSBA antibody titers Meningococcal rSBA antibody titers Meningococcal ELISA concentrations Meningococcal hSBA and rSBA vaccine response Occurrence of solicited local and general symptoms Occurrence of non-serious adverse events Occurrence of serious adverse events an new onset chronic illness(es) ;Timepoint(s) of evaluation of this end point: One month post booster vaccination with GSK134612 vaccine at year 5 after primary vaccination and one month post-primary vaccination in newly enrolled One year, three years, and five years after primary vaccination and one month post booster vaccination with GSK134612 vaccine at year 5 after primary vaccination and one month post-primary vaccination in newly enrolled One year after primary vaccination one month post booster vaccination with GSK134612 vaccine at year 5 after primary vaccination and one month post-primary vaccination in newly enrolled 4 days following vaccination 31 days following vaccination 6 months following vaccination | — |
Countries
United States
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed