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The purpose of this study is to evaluate the safety of a new conjugate vaccine, NmVac4-A/C/Y/W-135-DT, compared to the safety of a similar, licensed meningococcal A/C/Y/W-135-DT conjugate vaccine. The investigators will also evaluate the production of antibodies to of NmVac4-A/C/Y/W-135-DT™ conjugate vaccine compared to the licensed vaccine, as a measure of vaccine effectiveness.
Meningococcal disease is a potentially life-threatening bacterial infection. The disease most commonly is expressed as either meningococcal meningitis, an inflammation of the membranes surrounding the brain and spinal cord, or meningococcemia, the presence of bacteria in the blood. The most common symptoms include high fever, headache, neck stiffness, confusion, nausea, vomiting, lethargy, and rash. If not treated the disease can progress rapidly and can lead to shock and death, often within hours of the onset of symptoms. Neisseria meningitidis capsular polysaccharides are poor immunogens. However, conjugation of bacterial polysaccharides to immunogenic carrier proteins generally results in conjugates that induce strong anti-polysaccharide T-helper cell dependent immune responses, creating a longer-lasting immune response and thus protection against meningococcal infection. This study compares safety and antibody production induced by one intramuscular injection of either NmVac4-A/C/Y/W-135-DT or a licensed meningococcal A/C/Y/W-135-DT conjugate vaccine. Participants will attend a screening visit up to 4 weeks prior to Day 0, then will attend study visits for 8 weeks. There will be a study phone call at Days 2-3, then a post-study telephone call to subjects to assess safety at 26 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Vaccine | Experimental | NmVac4-A/C/Y/W-135-DT™ conjugate vaccine |
|
| US Licensed Vaccine | Active Comparator | Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| meningococcal meningitis conjugate vaccine, quadrivalent | Biological | NmVac4-A/C/Y/W-135-DT™conjugate is a vaccine in liquid form composed of purified polysaccharides (PS) conjugated to diphtheria toxoid. Single intramuscular 0.5 mL dose contains 4 µg each Serogroup A, C, W-135, Y PS conjugated to approximately 16 µg total diphtheria toxoid. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Reactions | local and systemic rates throughout the course of the study | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Immune Response | Antibody titers | 4 and 8 weeks after injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sudesh Nagavalli, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kings Cardiology Group | Hanford | California | 93230 | United States |
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| meningococcal meningitis conjugate vaccine, quadrivalent | Biological | Meningococcal (Groups A,C,Y and W-135-DT) Polysaccharide Conjugate Vaccine 0.5 mL dose, intramuscular. Single dose contains 4 µg each Serogroup A, C, W-135, Y PS conjugated to approximately 48 µg total diphtheria toxoid. |
|
| ID | Term |
|---|---|
| D008585 | Meningitis, Meningococcal |
| D008589 | Meningococcal Infections |
| D002494 | Central Nervous System Infections |
| D008581 | Meningitis |
| ID | Term |
|---|---|
| D016920 | Meningitis, Bacterial |
| D020806 | Central Nervous System Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |
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