EUCTR2008-003824-51-FI
Active, not recruiting
Not Applicable
A phase III, open, multi-centre, controlled study to evaluate the long-term antibody persistence at 2 years, 3 years and 4 years after a single dose of GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroup A, C, W-135, Y- tetanus toxoid conjugate (MenACWY-TT) vaccine versus one dose of Meningitec™ administered in healthy 12 through 23-month old children who were primed in study MenACWY-TT-039 (109670) and to evaluate the immunogenicity and safety of a booster dose of the same meningococcal conjugate vaccine as given in the primary study, 4 years after priming. - MENACWY-TT-048 EXT:039 Y2, 3, 4, 5
DrugsMeningitec
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- GlaxoSmithKline Biologicals
- Enrollment
- 992
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects who the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow\-up visits) should be enrolled in the study.
- •Written informed consent obtained from the parent(s) or guardian(s) of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •A male or female having completed the primary study MenACWY\-TT\-039 (109670\) and who was primed with MenACWY\-TT or Meningitec vaccines.
- •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
Exclusion Criteria
- •Exclusion criteria for persistence study entry (i.e. Month 24, 36 or 48\):
- •Use of any investigational or non\-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the subject’s first visit.
- •History of meningococcal disease\*.
- •Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine outside of study MenACWY\-TT\-039 (109670\).
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history (no laboratory testing is required).
- •Administration of immunoglobulins and/or blood products within the three months preceding the subjects first visit.
- •Concurrently participating in another clinical study, within 30 days of study entry, 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.
- •\* Meningococcal disease history has to be documented using a SAE form.
- •Additional exclusion criteria for booster vaccination (to be checked at Month 48\):
Outcomes
Primary Outcomes
Not specified
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