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| ID | Type | Description | Link |
|---|---|---|---|
| Impact N° 919 |
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Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in healthy children
The aim of this study is to investigate the immunogenicity offered by MenCC vaccine when administered in different schedules at different years of life: 2 doses in the first year of life given 2 months apart (at 2 and 4 months of age), with a booster in the second year of life, or 1 dose in the first year of life (at 2 or 6 months of age), with a booster in the second year of life, or only 1 dose in the second year of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: 2+4 Months (2-doses) | Experimental |
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| Group 2: 2 Months (1-dose) | Experimental |
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| Group 3: 6 Months (1-dose) | Experimental |
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| Group 4: 12-16 Months (1 dose in the second year of life) | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal C conjugate vaccine | Biological | Meningococcal conjugate vaccine, active comparator. Groups 1 to 3 were given a booster dose in the second year of life at 12-16 months of age |
| Measure | Description | Time Frame |
|---|---|---|
| Demonstration of non-inferiority of memory antibody response after 1 dose of MenC Vaccine administered to healthy infants at 2 to 6 months of age and as first, second or third dose in the second year of life,as measured by rBCA. | Overall study period |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation and comparison of antibody response and its persistence in terms of GMT and percent responders, as measured by rBCA. | Overall study period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines - Information Services | Novartis Vaccines & Diagnostics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mainz, Kehl, Neumünster, Ettenheim | Germany | |||||
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| ID | Term |
|---|---|
| C410218 | serogroup C meningococcal conjugate vaccine |
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| Kraków, Lubartów, Lublin, Bydgosczcz |
| Poland |