Safety, Tolerability and Immunogenicity of Meningococcal C Conjugate Vaccine to Children 32 to 40 Months of Age
Phase 4
Completed
- Conditions
- Meningococcal Infection
- Registration Number
- NCT00310635
- Lead Sponsor
- Novartis
- Brief Summary
Safety, Tolerability and Immunogenicity of Meningococcal C Conjugate Vaccine to Children 32 to 40 Months of Age
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 241
Inclusion Criteria
- Healthy children
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Exclusion Criteria
- known hypersensitivity to any vaccine component
- significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past 14 days
- ascertained or suspected disease caused by N. meningitidis
- household contact with or intimate exposure to an individual with a positive culture of N. meningitidis serogroup C within the previous 60 days
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Determination of memory antibody response to Neisseria meningitidis serogroup C after 2 or 3 doses of MenC vaccine given during infancy, as measured by hBCA at day 0 and day 28.
- Secondary Outcome Measures
Name Time Method Determination of antibody titers in naïve control subjects. Determination of persistence of antibody response after either 2 or 3 doses of MenC vaccine given during infancy and one dose of MenPS A/C vaccine given at 12 months of age. Evaluation of the safety and tolerability of a single 0.5 mL intramuscular (IM) injection of MenC Vaccine when given to children approximately three years of age.
Trial Locations
- Locations (1)
Mainz, Kehl, Traunreut, Mühldorf am Inn, Bad Sobernheim, Bad Kreuznach, Baldham, Speyer,
🇩🇪Oppenheim,, Kempten, Germany