Primary immunization of healthy adolescents/young adults against meningococcal disease due to Neisseria meningitidis (N. meningitidis) of serogroups A, C, W-135 and Y
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects who the investigator believes they and/or their parents/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, 15 and 19 years of age at the time of the first vaccination. - Written informed consent obtained from the subject prior to enrolment (for subjects below the legal age of consent, written informed consent must be obtained from a parent or legally acceptable representative and, in addition, the subject should sign and personally date a written informed assent). - 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 knowledge and/or his/her parents/legally acceptable representative’s knowledge. - If the subject is female, she must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (i.e. intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant® or DepoProvera®) for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after the vaccination. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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: - 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 during thestudy period. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.) - Any chronic drug therapy to be continued during the study period. - Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the study vaccine dose. - Previous vaccination against meningococcal disease of serogroup A, C, W-135 or Y. - Previous vaccination against tetanus within the last 6 months. - History of meningococcal disease. - Known exposure to N. meningitidis of serogroup A, C, W-135 or Y within previous 12 months. - 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., Axillary temperature <37.5°C / Oral 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. - Pregnant or lactating female. - Female planning to become pregnant or planning to discontinue contraceptive precautions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the immune response induced by four different formulations of GSK Biologicals’ MenACWY-TT candidate conjugate vaccine versus MENCEVAX™ ACWY in healthy adolescents/young adults aged 15-19 years.;Secondary Objective: To evaluate the safety and reactogenicity of four different formulations of GSK Biologicals’ MenACWY-TT candidate conjugate vaccine versus MENCEVAX™ ACWY in healthy adolescent/young adults aged 15-19 years;Primary end point(s): One month after the vaccine dose, in all subjects: - Percentage (%) of serum bactericidal activity SBA-MenA, SBA-MenC, SBA-MenW-135 and SBA-MenY responders.* *A responder is defined as a subject having a greater than or equal to a 4-fold increase in SBA titer from pre to post vaccination. | — |
Countries
Belgium
Outcome results
None listed