Immunogenicity, Safety and Tolerability, of Chiron Meningococcal C Conjugate Vaccine Administered to Healthy Premature and Non Premature Children of 3 Months of Age
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00310674|
Recruitment Status : Completed
First Posted : April 4, 2006
Last Update Posted : March 13, 2007
|Condition or disease||Intervention/treatment||Phase|
|Prevention of Meningococcal Infection||Biological: Meningococcal C Conjugate Vaccine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III, Single Center, Open Label, Uncontrolled Study to Evaluate the Immunogenicity, Safety and Tolerability, of the Chiron Meningococcal C Conjugate Vaccine When Administered to Healthy Premature and Non Premature Children at 3, 5, 11 Months of Age Concomitantly With a Hexavalent Infant Vaccine|
|Study Start Date :||September 2004|
- antibody response, as measured by ELISA, to N. meningitidis serogroup C at one month following three doses of MenC Conjugate Vaccine administered at 3, 5, 11 months of age, together with a hexavalent vaccine.
- safety and tolerability
- antibody response as measured by ELISA at 1 month after second dose of MenC Vaccine and before third dose with hexavalent vaccine
- antibody response as measured by BCA in subset of subjects in each group, at 1 month after second dose, immediately before the third and at 1 month following the third dose of MenC Vaccine together with a hexavalent vaccine.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00310674
|Istituto di Pediatria, Università degli Studi di Milano|
|Milano, Italy, 20122|
|Principal Investigator:||Novartis - Information Services||Novartis Vaccines & Diagnostics|