Safety Study of Group A, C, Y & W-135 Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine for Meningitis
Condition: Meningococcal Meningitis; Meningococcal Infections
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): meningococcal meningitis conjugate vaccine, quadrivalent; meningococcal meningitis conjugate vaccine, quadrivalent
Intervention type(s): Biological; Biological
Intervention description(s): 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.; 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.
Other intervention name(s): NmVac4-A/C/Y/W-135-DT™
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Central Nervous System Infections; Meningitis; toxoid; Meningococcal vaccine; conjugate vaccines