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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003085-41 | EudraCT Number |
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Invasive meningococcal disease is a worldwide problem with serious repercussions for those affected. Vaccination is recognized as the best way to combat it. The cost of vaccination is prohibitive in many low-resource settings at home and abroad. By harnessing the special immunologic properties of the skin, a dose reduction may be achieved by intradermal administration of the vaccine. The cost savings associated with dose reduction will increase availability of the vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Menveo, dose escalating | Experimental |
| |
| Nimenrix, dose escalating | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEN-ACYW135 reduced-dose intradermal administration | Biological | Modified traditional dose escalation rule (TER) in an adaptive design. The study will be performed in duplicate, with 2 vaccines. |
| Measure | Description | Time Frame |
|---|---|---|
| Seroprotection rate against meningococcal serogroups ACYW135 (anti-meningococcal antibody titre at baseline and 28 days after vaccination) | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Local and systemic adverse events (subject log and investigator inspection). | 28 days |
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Inclusion Criteria:
Meningococcal C naive subjects are required to fulfill all of the following criteria:
Meningococcal C experienced subjects are required to fulfill all of the following criteria:
Exclusion Criteria:
Meningococcal C naïve subjects should not have:
Meningococcal C experienced subjects should not have:
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| Name | Affiliation | Role |
|---|---|---|
| Leo Visser, MD, PhD | Leiden University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden University Medical Center | Leiden | South Holland | 2333ZA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29778515 | Derived | Jonker EFF, van Ravenhorst MB, Berbers GAM, Visser LG. Safety and immunogenicity of fractional dose intradermal injection of two quadrivalent conjugated meningococcal vaccines. Vaccine. 2018 Jun 18;36(26):3727-3732. doi: 10.1016/j.vaccine.2018.05.064. Epub 2018 May 16. |
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| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D022401 | Meningococcal Vaccines |
| ID | Term |
|---|---|
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
| D007239 | Infections |