EUCTR2012-005816-25-FI
Active, not recruiting
Phase 1
A phase III, open, multi-centre, controlled study to evaluate the long-term antibody persistence at 2, 3, 4, 5 and 6 years after a booster dose of meningococcal serogroup A, C, W-135, Y- tetanus toxoid conjugate vaccine (MenACWY-TT) or Meningitec® administered in healthy 5-year-old children in study MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036), who were primed with thesame vaccine in study MENACWY-TT-039 (109670) at 12 through 23 months of age. - C0921001 (MENACWY-TT-102 EXT: 048 Y2, 3, 4, 5, 6)
Pfizer Inc (235 East 42nd Street, New York, New York 10017)0 sites248 target enrollmentMay 17, 2013
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Pfizer Inc (235 East 42nd Street, New York, New York 10017)
- Enrollment
- 248
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All subjects must satisfy ALL the following criteria at study entry:
- •Subjects’ parent(s)/Legally Acceptable Representative(s) \[LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. return for follow\-up visits).
- •A male or female who has received primary and booster vaccination with the MenACWY\-TT or Meningitec vaccines in studies MENACWY\-TT\-039 (109670\) and MENACWY\-TT\-048 EXT: 039 Y2, 3, 4, 5 (112036\), respectively.
- •Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 248
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range 0
- •F.1\.3 Elderly (\>\=65 years) no
Exclusion Criteria
- •The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
- •Child in care
- •History of meningococcal disease.
- •Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine outside of studies MENACWY\-TT\-039 (109670\) and MENACWY\-TT\-048 EXT: 039 Y2, 3, 4, 5 (112036\).
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •Bleeding disorders, such as thrombocytopenia, or subjects on anti\-coagulant therapy.
Outcomes
Primary Outcomes
Not specified
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