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
- Conditions
- Vaccination of children 2 to 10 years of age against invasive disease caused by meningococcal serogroups A, C, W-135, and Y.MedDRA version: 12.1Level: LLTClassification code 10027274Term: Meningococcal infection
- Registration Number
- EUCTR2010-018730-51-FR
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 282
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:
- has practiced adequate contraception (including abstinence) for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception (including abstinence) during the entire treatment period and for 2 months after completion of the vaccination series.
Are the trial subjects under 18? yes
Number of subjects for this age range:
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
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
•Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
•Subjects in contact with somebody suffering from an invasive infection with meningococcal serogroups A, C, Y or W-135.
•Subjects living in a geographic area where local outbreak with meningococcal serogroup C has occurred and would thus be likely to participate in a vaccination campaign against meningococcal serogroup C.
Booster only:
•Hypersensitivity to latex.
•Planned administration/ administration of a vaccine not foreseen by the study protocol within the last 30 days of the dose of vaccine(s) with the exception of a licensed inactivated influenza vaccine.
•Previous vaccination with tetanus toxoids within the last 30 days (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.
•History of any neurological disorders or seizures (although subjects with a prior history of a single episode of benign febrile seizures may be allowed to participate in the study).
•Acute disease and/or fever at the time of vaccination.
-Fever is defined as rectal temperature =38°C / axillary temperature =37.5°C / oral temperature of =37.5°C / tympanic temperature on oral setting =37.5°C.
-Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
•History of chronic alcohol consumption and/or drug abuse.
•History of hypotonic-hyporesponsive episodes (HHEs) following vaccination.
•Pregnant or lactating female.
•Female of child-bearing potential planning to become pregnant or planning to discontinue contraceptive precautions.
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