Safety, Tolerability and Immunogenicity of Meningococcal C Conjugate Vaccine to Children 32 to 40 Months of Age
|ClinicalTrials.gov Identifier: NCT00310635|
Recruitment Status : Completed
First Posted : April 4, 2006
Last Update Posted : October 26, 2006
|Condition or disease||Intervention/treatment||Phase|
|Meningococcal Infection||Biological: Meningococcal C conjugate vaccine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||241 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase IV, Multi-Center, Controlled Open-Label Study to Evaluate the Safety, Tolerability and Immunogenicity of a Commercially Available Meningococcal C Vaccine When Given as First, Third or Fourth Immunization to Children 32-40 Months of Age|
|Study Start Date :||June 2005|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00310635
|Mainz, Kehl, Traunreut, Mühldorf am Inn, Bad Sobernheim, Bad Kreuznach, Baldham, Speyer,|
|Oppenheim,, Kempten, Germany|
|Principal Investigator:||Vaccines - Information Services||Novartis Vaccines & Diagnostics|