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This study is aimed at studying quadrivalent meningococcal (A, C, Y, and W-135) Tetanus Protein Conjugate Vaccine (TetraMen-T) formulations in Toddlers.
Primary Objectives: Safety and Immunogenicity:
To describe the safety and immunogenicity profiles of:
The study is designed to evaluate the safety profile and the immunogenicity response after a single dose of TetraMen-T in toddlers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental |
| |
| Group 2 | Experimental |
| |
| Group 3 | Experimental |
| |
| Group 4 | Experimental |
| |
| Group 5 | Experimental |
| |
| Group 6 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal Polysaccharide Tetanus Protein Conjugate | Biological | 0.5 mL, Intramuscular |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To provide information concerning the safety and immunogenicity after administration of TetraMenT | 30 days after each injection |
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Inclusion Criteria :
Exclusion Criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herston | Australia | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22094636 | Result | McVernon J, Nolan T, Richmond P, Reynolds G, Nissen M, Lambert SB, Marshall H, Papa T, Rehm C. A randomized trial to assess safety and immunogenicity of alternative formulations of a quadrivalent meningococcal (A, C, Y, and W-135) tetanus protein conjugate vaccine in toddlers. Pediatr Infect Dis J. 2012 Jan;31(1):e15-23. doi: 10.1097/INF.0b013e31823e1e34. |
| Label | URL |
|---|---|
| Related Info | View source |
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| Meningococcal Polysaccharide Tetanus Protein Conjugate |
| Biological |
0.5 mL, Intramuscular |
|
| Meningococcal Polysaccharide Tetanus Protein Conjugate | Biological | 0.5 mL, Intramuscular |
|
| Meningococcal Polysaccharide Tetanus Protein Conjugate | Biological | 0.5 mL, Intramuscular |
|
| Meningococcal Polysaccharide Tetanus Protein Conjugate | Biological | 0.5 mL, Intramuscular |
|
| Meningococcal polysaccharide group C conjugated | Dietary Supplement | 0.5 mL, Intramuscular |
|
|
| Melbourne |
| Australia |
| North Adelaide | Australia |
| Perth | Australia |
| Westmead | Australia |
| ID | Term |
|---|---|
| D008581 | Meningitis |
| D008589 | Meningococcal Infections |
| ID | Term |
|---|---|
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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