Study in Adolescents/Adults to Evaluate Non-Inferiority & Persistence up to 5 Years of GSK Biologicals’ MenACWY Conjugate Vaccine

• Conditions: Prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and/or Y; MedDRA version: 18.0Level: LLTClassification code 10028911Term: Neisseria meningitidis infection NOSSystem Organ Class: 100000004862; MedDRA version: 18.0Level: LLTClassification code 10070124Term: Neisseria meningitidis test positiveSystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2012-002722-75-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-22
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Subjects who the investigator believes that they and/or their parents/legally acceptable representative (LAR) can and will comply with the requirements of the protocol.
• A male or female between, and including, 11 and 55 years of age at the time of vaccination.
• Written informed consent obtained from the subject/ from the parent or LAR of the subject.
• 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’/LARs’ knowledge.
• If the subject is female, she must be of non-childbearing potential, i.e. either surgically sterilised or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, and must agree to continue such precautions for two months after completion of the vaccination series. Female subjects in childbearing potential who are not abstinent must have a negative pregnancy test.
Are the trial subjects under 18? yes
Number of subjects for this age range: 301
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 199
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the 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 within six months prior to the vaccine dose.
• Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine(s).
• Previous vaccination with meningococcal polysaccharide (PS) vaccine of serogroup A, C W and/or Y within the last five previous years.
• Previous vaccination with meningococcal PS conjugate vaccine of serogroup A, C W and/or Y.
• History of meningococcal disease due to serogroup A, C, W or Y.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
• A family history of congenital or hereditary immunodeficiency.
• History of allergic disease or reactions likely to be exac-erbated by any component of the vaccine.
• Major congenital defects or serious chronic illness.
• History of any neurologic disorders or seizures.
• History of Guillain-Barré syndrome.
• Acute disease at the time of enrolment.
• 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.
• History of chronic alcohol consumption and/or drug abuse.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.
Specific criteria to be checked at each study visit for the long term follow-up:
• History of meningococcal serogroup A,C, W and Y disease.
• Administration of a meningococcal PS or a meningococcal PS conjugate vaccine not planned in the protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified