Safety and Immunogenicity of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in To… (NCT00631995) | Clinical Trial Compass
CompletedPhase 1
Safety and Immunogenicity of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Toddlers
Australia360 participantsStarted 2008-04
Plain-language summary
This study is aimed at studying quadrivalent meningococcal (A, C, Y, and W-135) Tetanus Protein Conjugate Vaccine (TetraMen-T) formulations in Toddlers.
Primary Objectives: Safety and Immunogenicity:
To describe the safety and immunogenicity profiles of:
* A single dose of each formulation of TetraMen-T vaccine
* A single dose of NeisVac-C® vaccine.
Who can participate
Age range12 Months – 12 Months
SexALL
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Inclusion Criteria :
* Subject is healthy, as determined by medical history and physical assessment.
* Aged 12 months (± 21 days) on the day of inclusion.
* Institutional Review Board (IRB)-approved informed consent form signed by the subject's parent/legal guardian.
* Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion Criteria :
* Serious acute or chronic disease (e.g., cardiac, renal, metabolic, rheumatologic, psychiatric, hematologic, or autoimmune disorders, diabetes, atopic conditions, congenital defects, convulsions, encephalopathy, blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic system, acute untreated tuberculosis) that could interfere with trial conduct or completion.
* Known or suspected impairment of immunologic function.
* Acute medical illness within the last 72 hours, or temperature ≥ 37.5ºC (axillary) at the time of enrollment (temporary contraindication).
* History of documented invasive meningococcal disease or previous meningococcal vaccination.
* Known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C seropositivity as reported by the parent or legal guardian.
* Received either immune globulin or other blood products within the last 3 months, or received injected or oral corticosteroids or other immunomodulator therapy within 6 weeks of the study vaccines. Individuals on a tapering dose schedule of oral steroids lasting \< 7 days and i…
What they're measuring
1
To provide information concerning the safety and immunogenicity after administration of TetraMenT