A phase IIIb, open, multi-centre, controlled study to assess the long-term persistence of antibodies after a single dose of GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroup ACWY tetanus-toxoid conjugate vaccine (MenACWY-TT) versus one dose of Novartis’ meningococcal serogroup C CRM197 conjugate vaccine (Menjugate®) administered in healthy subjects aged 2 through 10 years in study MENACWY-TT-081 PRI (111414) and to evaluate the safety and immunogenicity of a booster dose of MenACWY-TT, administered 68 months post-primary vaccination. - MENACWY-TT-088 EXT:081 M32, 44, 56, 68

GlaxoSmithKline Biologicals0 sites282 target enrollmentJuly 9, 2010

Overview

No summary available.

Registry

who.int

Start Date

July 9, 2010

End Date

May 17, 2014

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•All subjects must satisfy ALL the following criteria at study entry:
•Subjects who the investigator believes that their parent(s)/LAR(s) can and will comply with the requirements of the protocol (e.g. return for follow\-up visits) should be enrolled in the study.
•A male or female who was primed with MenACWY\-TT or Menjugate in the primary vaccination study MENACWY\-TT\-081 PRI (111414\).
•Written informed consent obtained from the parent(s)/LAR(s) of the subject and written informed assent obtained from the subject (at investigator discretion).
•Healthy subjects as established by medical history and clinical examination before entering into the study.
•All subjects must meet the additional following criteria prior to receiving the booster vaccination:
•Subjects who had a blood sample taken at Visit 4 during the persistence epoch of the current study.
•Female subjects of non\-childbearing potential may be enrolled in the study.
•\- Non\-childbearing potential is defined as pre\-menarche (absence of menses).
•Female subjects of childbearing potential may be enrolled in the study, if the subject:

•Persistence and Booster
•Child in care.
•Use of any investigational or non\-registered product (drug or vaccine)
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune\-modifying drugs. (For corticosteroids, prednisone \<10 mg/day, or equivalent, inhaled and topical steroids are allowed).
•Concurrently participating in another clinical study or planned participation in another clinical study, at any time during the study period (from the time of the booster until the end of the study), in which the subject has been or will be exposed to an investigational or a non\-investigational product (pharmaceutical product or device).
•History of meningococcal disease
•Vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, B, C, W\-135, and/or Y since the previous vaccination in the primary vaccination study
•Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing is required).
•Serious chronic illness
•Administration of immunoglobulins and/or any blood products