Meningococcal disease MedDRA version: 14.1 Level: LLT Classification code 10028911 Term: Neisseria meningitidis infection NOS System Organ Class: 100000004862 MedDRA version: 14.1 Level: LLT Classification code 10070124 Term: Neisseria meningitidis test positive System Organ Class: 100000004848
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Healthy subjects as established by medical history and clinical examination before entering into the study. •Subjects and subjects’ parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol. •A male or female between, and including, 11 and 25 years of age at the time of the first vaccination. •Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject. •Written informed assent obtained from the subjects when applicable according to local regulations. •Female subjects of non-childbearing potential may be enrolled in the study. •Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy or ovariectomy. •Female subjects of childbearing potential may be enrolled in the study, if the subject: -has practiced adequate contraception for 30 days prior to vaccination, and -has a negative pregnancy test on the day of vaccination, and -has agreed to continue adequate contraception during the entire treatment period and for two months after completion of the vaccination series. Are the trial subjects under 18? yes Number of subjects for this age range: 345 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 345 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Child in care. •Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone = 10 mg/day, or equivalent. Inhaled and topical steroids are allowed. •Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose of vaccine and ending 30 days after the last dose of vaccine, with the exception of licensed inactivated influenza vaccine. •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. •Previous vaccination with a meningococcal vaccine. •History of meningococcal disease. •Vaccination with a DTP-containing vaccine within the previous five years. •History of serious allergic reaction following any other DTP-containing vaccine or any component of the study vaccines. •History of encephalopathy within seven days following administration of a previous dose of pertussis vaccine that is not attributable to another identifiable cause. •Temperature of = 40.5°C (105°F) within 48 hours of receipt of a previous dose of DTP vaccine, not due to another identifiable cause. •Collapse or shock-like state within 48 hours of receipt of a previous dose of DTP vaccine. •Seizures with or without fever within three days of a previous dose of DTP vaccine. •Severe Arthus-type hypersensitivity reactions following a prior dose of tetanus toxoid (TT) within the previous ten years. •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination during the study period. •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). •Progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy. •History of any neurologic disorders or seizures, including Guillain-Barré syndrome (GBS). History of a simple, single febrile seizure is permitted. •Bleeding disorders, such as haemophilia or thrombocytopenia, or subjects on anticoagulant therapy. •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. •Pregnant or lactating female. •Female planning to become pregnant or planning to discontinue contraceptive precautions. •Family history of congenital or hereditary immunodeficiency. •Major congenital defects or serious chronic illness. •Acute disease and/or fever at the time of enrolment. -Fever is defined as temperature = 37.5°C /99.5°F for oral, axillary or tympanic route. -Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: •To evaluate the immunogenicity of MenACWY-TT co-administered with Boostrix® or administered alone in all three study groups with respect to (1) the percentage of subjects with rSBA titres = 1:8, = 1:128 prior to and one month after MenACWY-TT vaccination, and (2) the vaccine response one month after MenACWY-TT vaccination. •To evaluate the immunogenicity of Boostrix® co-administered with MenACWY-TT compared to Boostrix® administered alone with respect to (1) anti-D and anti-T GMCs, and (2) a booster response to PT, FHA and PRN one month after Boostrix® vaccination in all three study groups. •To compare the immunogenicity of MenACWY-TT given one month after Boostrix® to MenACWY-TT given one month before Boostrix® and vice versa. •To evaluate the safety and reactogenicity after vaccination with MenACWY-TT and Boostrix® in terms of solicited symptoms, unsolicited symptoms, serious adverse events and new onset of chronic illnesses throughout the study following each vaccination. ;Primary end point(s): 1)rSBA-MenA, rSBA-MenC, rSBA -MenW-135 and rSBA-MenY GMTs 2)Anti-D and anti-T concentrations =1.0 IU/mL Anti-PT, anti-FHA and anti-PRN GMCs. ;Timepoint(s) of evaluation of this end point: 1)One month after MenACWY-TT vaccination in the Co-ad and ACWYTdap groups 2)One month after Boostrix® vaccination in the Co-ad and TdapACWY groups;Main Objective: •To demonstrate the non-inferiority of MenACWY-TT co-administered with Boostrix® compared to MenACWY-TT administered alone with respect to serum bactericidal assay using rabbit complement (rSBA) geometric mean titres (GMTs) for serogroups A, C, W-135 and Y one month after MenACWY-TT vaccination. •To demonstrate the non-inferiority of Boostrix® co-administered with MenACWY-TT compared to Boostrix® administered alone in terms of anti-diphtheria toxoid (anti-D) and anti-tetanus toxoid (anti-T) antibody concentrations one month after Boostrix® vaccination. •To demonstrate the non-inferiority of Boostrix® co-adm | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1)rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titres = 1:8 and = 1:128 2)rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY GMTs 3)rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY vaccine response 4)Anti-D and anti-T concentrations =1.0 IU/mL 5)Anti-D GMCs and seroprotection rates. 6)Anti-T GMCs and seroprotection rates 7)Anti-PT, anti-FHA and anti-PRN concentrations = 5.0 EL/mL 8)Anti-PT, anti-FHA and anti-PRN GMCs 9)Booster responses for anti-PT, anti-FHA and anti-PRN concentrations 10)Occurrence of NOCIs (asthma, autoimmune disorders, type 1 diabetes and allergies) ;Timepoint(s) of evaluation of this end point: 1)Prior to and one month after MenACWY-TT vaccination in all study groups 2)Prior to and one month after MenACWY-TT vaccination in the TdapACWY group 3)One month after MenACWY-TT vaccination in all study groups 4)One month after Boostrix® vaccination in the ACWYTdap group 5)Prior to and one month after Boostrix® vaccination 6)All time points in all study groups 7)Prior to and one month after Boostrix® vaccination in all study groups 8)One month after Boostrix® vaccination in the ACWYTdap group 9)One month after Boostrix® vaccination in all study groups 10)Throughout the study (Month 0 – Month 2) | — |
Countries
Dominican Republic, Germany, Korea, Democratic People's Republic of
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed