Immunogenicity and safety study of one dose of GSK Biologicals? meningococcal conjugate vaccine (GSK134612) in healthy adolescents aged 10 to 15 years.

• Conditions: Healthy subjects (active immunisation of individuals from the age of 12 months against invasive meningococcal diseases caused by Neisseria meningitidis serogroup A, C, W-135 and Y).; MedDRA version: 16.1Level: LLTClassification code 10028911Term: Neisseria meningitidis infection NOSSystem Organ Class: 100000004862; MedDRA version: 16.1Level: LLTClassification code 10070124Term: Neisseria meningitidis test positiveSystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2013-004778-84-ES
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-25
• Last Update Posted: 30 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

? 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, 10 and 15 years of age at the time of vaccination.
? For the MenC-TT group, a subject who has been vaccinated with a MenC-TT conjugate vaccine in infancy and/or at toddler age (i.e., according to schedule 3+1, 2+1, 1+1, 1), and for whom vaccination is documented.
? For the MenC-CRM group, a subject who has been vaccinated with a MenC-CRM conjugate vaccine in infancy and/or at toddler age (i.e., according to schedule 3+1, 2+1, 1+1, 1), and for whom vaccination is documented.
? For the noMenC group, a subject who has not previously received any dose of MenC vaccine per documentation.
? Written informed consent obtained from the subject/subject?s parent(s)/LAR(s) as applicable according to local regulations.
? Written informed assent obtained from the subjects when applicable according to local regulations.
? Healthy subjects as established by medical history and clinical examination before entering into the study.
? For female subjects of non-childbearing potential:
These subjects may be enrolled in the study.
- In this study, non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy or ovariectomy.
? For female subjects of childbearing potential:
These subjects 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: 600
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

? Child in care
? Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
? Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. (For corticosteroids, this will mean prednisone ? 0.5 mg/kg/day with an upper limit of 10 mg/kg 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 and ending 30 days after the dose of vaccine (i.e., after blood sampling Visit 2), with the exception of a 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 vaccine/product (pharmaceutical product or device).
? Previous vaccination against N. meningitidis with the exception of MenC vaccine for the MenC-TT and MenC-CRM groups.
? For the MenC-TT and MenC-CRM groups, vaccination against N. meningitidis serogroup C after two years of age.
? For the noMenC group, previous vaccination with any meningococcal vaccine.
? Previous vaccination with any TT-containing vaccine within 30 days prior to the first visit.
? History of, or intercurrent, meningococcal disease.
? Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
? Family history of congenital or hereditary immunodeficiency.
? History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
? Major congenital defects or serious chronic illness.
? History of any neurological disorders or seizures, including Guillain-Barré syndrome (GBS). History of a simple, single febrile seizure is permitted.
? Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature >=37.5°C for oral, axillary or tympanic route, or >= 38.0°C on rectal route. The preferred route for recording temperature in this study will be axillary. The oral route is also allowed.
- Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever, may be enrolled at the discretion of the investigator
? Administration of immunoglobulins and/or any blood products within the three months preceding the study vaccination or planned administration during the study period.
? History of chronic alcohol consumption and/or drug abuse.
? Anaphylaxis following the administration of vaccine(s).
? 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