The long-term antibody persistence of GSK Biologicals’ meningococcal vaccine GSK134612 in healthy toddlers

Active, not recruiting

• Conditions: Invasive disease caused by Neisseria meningitidis serogroups A, C W-135 and Y; MedDRA version: 18.0Level: LLTClassification code 10028910Term: Neisseria meningitides meningitisSystem Organ Class: 100000004862; MedDRA version: 18.0Level: LLTClassification code 10028911Term: Neisseria meningitidis infection NOSSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2012-002719-24-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-01
• Last Update Posted: 2015-07-10

Recruitment & Eligibility

• Status: Active
• Sex: All
• Target Recruitment: 372

Inclusion Criteria

All subjects must satisfy the following criteria for the per-sistence phase of the study entry:
•A male or female toddler who was vaccinated 1, 3 or 5 years ago with the last dose of MenACWY-TT in study with NCT number=00471081.
•Written informed consent obtained from parents/guardian of the subject.
•Healthy subjects as established by medical history before entering into the study.
•Having completed the active phase of the vaccination study with NCT number=00471081 (i.e., not withdrawn, had received all planned doses of study vaccines, provided a post-vaccination blood sample after the final dose).
All subjects must meet the following criteria prior to receiving the booster vaccination:
•Written informed consent obtained from parents/guardian of the subject.
•Subjects who can and will comply with the requirements of the protocol.
•Subjects who provide a blood sample 5 years after last vaccination in study with NCT number=00471081.
Are the trial subjects under 18? yes
Number of subjects for this age range: 387
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

Exclusion criteria for persistence study entry
•Use of any investigational or non-registered product (drug or vaccine) within 30 days of each persistence timepoint.
•Vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, B, C, W-135, and/or Y outside of study with NCT number=00471081.
•History of any meningococcal disease due to serogroup A, B, C, W-135, or Y.
•Any confirmed or suspected immunosuppressive or im-munodeficiency condition based on medical history and physical examination (no laboratory testing is required).
•Administration of immunoglobulins and/or any blood products within the three months preceding each persistence timepoint.
•Concurrently participating in another clinical study within 30 days of each persistence timepoint, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
•Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
•Subjects withdrew consent to be contacted for follow-up studies.
Exclusion criteria for booster vaccination at year 5 study entry (to be checked at Year 5)
•Subjects who were enrolled in the Kaiser Healthcare system in study with NCT number=00471081, but are no longer enrolled.
•Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the booster vaccina-tion, 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 booster vaccination. (For corticosteroids, this will mean prednisone, or equivalent, = 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
•Vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, B, C, W-135, and/or Y outside of study with NCT number=00471081.
•History of any meningococcal disease due to serogroup A, B, C, W-135, or Y.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history (no laboratory testing is required).
•Administration of immunoglobulins and/or any blood products within the three months preceding the booster vaccination or planned administration during the study period.
•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 (pharmaceutical product or device).
•Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
•Subjects withdrew consent to be contacted for follow-up studies.
•Hypersensitivity to latex.
•Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine(s) with the exception of any licensed inactivated influenza vaccine (live attenuated influenza vaccine is not allowed).
•Previous vaccination with tetanus and diphtheria toxoids within the last month (i.e., Tdap, Td, and TT-containing vaccine).
•A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
•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 neurological disorders or seizures.
•Acute disease at the time of vaccination. (Acute disease is defined

Study & Design

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