A phase II open (partially double-blind), randomized, controlled, primary vaccination study to assess the immunogenicity, safety and reactogenicity of one intramuscular dose of four different formulations of GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroups A, C, W-135, Y-tetanus toxoid conjugate (MenACWY-TT) vaccine versus one subcutaneous dose of MENCEVAX™ ACWY in healthy adolescents/young adults aged 15-19 years - MenACWY-TT-009
- Conditions
- Primary immunization of healthy adolescents/young adults against meningococcal disease due to Neisseria meningitidis (N. meningitidis) of serogroups A, C, W-135 and Y
- Registration Number
- EUCTR2004-004248-37-BE
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method