The long-term antibody persistence of GSK Biologicals’ meningo-coccal vaccine GSK134612 in healthy adolescents/adults.
- Conditions
- Invasive disease caused by Neisseria meningitidis serogroups A, C W-135 and YMedDRA version: 18.0Level: LLTClassification code 10028910Term: Neisseria meningitides meningitisSystem Organ Class: 100000004862MedDRA version: 18.0Level: LLTClassification code 10051931Term: Neisseria infection NOSSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2012-002718-38-Outside-EU/EEA
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 749
Persistence phase:
•A male or female who was between and including 10 and 25 years of at the time of primary vaccination in the study with NCT number = 00454909.
•Written informed consent obtained from parents/guardian of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday.
•Healthy subjects as established by medical history.
•Having completed the active phase of the vaccination study with NCT number = 00454909..
Booster phase:
•Written informed consent obtained from parents/guardian of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday.
•Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
•Healthy subjects as established by medical history and history-directed physical examination before entering into the study.
•If the subject is female, she must be of non-childbearing potential, i.e., pre-menarche, have a current tubal ligation, hysterectomy, oopherectomy or be post-menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test on the day of vaccination and continue adequate contraception for 2 months after vaccination.
Additional inclusion criterion for the naïve control group:
•A male or female between, and including, 15 and 30 years of age (has not attained his/her 31st birthday) at the time of the vaccination.
Are the trial subjects under 18? yes
Number of subjects for this age range: 68
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 580
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Persistence phase:
•Use of any investigational or non-registered product within 30 days of each persistence time point.
•Vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C, W-135, and/or Y outside of study with NCT number = 00454909.
•History of any meningococcal disease due to serogroup A, B, C, W-135, or Y.
•Any confirmed or suspected immunosuppressive or im-munodeficient condition, based on medical history
•Administration of immunoglobulins and/or any blood prod-ucts within the three months preceding each persistence time point.
•Concurrently participating in another clinical study within 30 days of each persistence time point, in which the subject has been or will be exposed to an investigational or a non-investigational product
•Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
•Chronic alcohol or drug abuse.
•Subjects withdrew consent to be contacted for follow-up studies.
Booster phase (to be checked at Year 5 for all subject, including naïve control group):
•Child in care
•Not enrolled in the Kaiser Healthcare system.
•Use of any investigational or non-registered product within 30 days preceding administration of the study vaccine, or planned use throughout the extended safety follow-up period.
•Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to administration of the booster dose
•Previous vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C, W-135, and/or Y outside of study with NCT number = 00454909.
•History of any meningococcal disease
•Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection based on medical history and physical examination
•Administration of immunoglobulins and/or any blood products within the three months preceding the booster vaccination or planned administration through Day 30 after vaccination.
•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
•Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
•History of chronic alcohol consumption and/ or drug abuse.
•Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days before until 30 days after the day of administration of the dose of vaccine(s) with the exception of any licensed inactivated influenza vaccine
•Previous vaccination with tetanus and diphtheria toxoids within the last month.
•A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vac-cine recipient is demonstrated.
•History of allergic disease or any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine, including latex.
•Major congenital defects or serious chronic illness.
•History of any neurological disorders or seizures.
•Previous history of Guillain-Barré syndrome
•Acute disease at the time of vaccination.
•Pregnant or lactating female.
•Female planning to become pregnant or planning to discontinue contraceptive precautions within 2 months after vaccination.
•For subjects who participated in the primary study NCT number = 00454909: Subjects withdrew consent to be contacted for follow-up studies
•Note: If the su
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