Status:
COMPLETED
Safety Study of Group A, C, Y & W-135 Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine for Meningitis
Lead Sponsor:
JN-International Medical Corporation
Conditions:
Meningococcal Meningitis
Meningococcal Infections
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief 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...
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...
Eligibility Criteria
Inclusion
- Willing and able to give informed consent and comply with all aspects of the evaluation after the nature of the study is explain
- For the purpose of this study, a healthy volunteer is defined as healthy male or female, with no significant chronic conditions
- Age 18 to 50 years old
- Either gender. Abstinence or use of contraception during the eight weeks after vaccination will be required for non menopausal (\< two years post-menopause) or non surgically sterile women
- Persons with antibody titer(s) of \<2 µg/mL to serogroup(s) A, C, Y, or W-135 polysaccharides as measured by ELISA
Exclusion
- Age less than 18 years or over 50 years.
- History of Guillain-Barré syndrome (GBS).
- Pregnancy or lactation.
- History of meningococcal meningitis.
- History of invasive (clinical or laboratory diagnosis) meningococcal disease.
- History of meningococcal meningitis vaccination.
- Screening laboratory abnormalities (in the opinion of the Investigator) that would raise safety concerns for participation in the study.
- Use of immunosuppressive drugs within 30 days prior to study enrollment, not including topical or inhaled steroids/cytotoxic agents.
- History of anaphylactic shock, asthma, urticaria, or other allergic or hypersensitivity reactions following vaccination.
- History of severe allergic disorders or autoimmune connective tissue disorders, including rheumatoid arthritis. A high sensitivity C-Reactive Protein (CRP) test at screening will be used as part of the assessment of autoimmune disorders by the Principal Investigator.
- Use of systemic antibiotics within 72 hours prior to study enrollment.
- History of cirrhosis.
- Positive results of testing for HepBsAg, Hepatitis C or HIV-1 or HIV-2 antibodies.
- Positive results of drug screen (amphetamine, THC, cocaine).
- Persons with antibody titer(s) of \>2 µg/mL to serogroup (s) A, C, Y, or W 135 as measured by ELISA.
- Unable to understand all of the study requirements.
- Prisoners.
- Participation in a clinical trial in the last three months.
- History of any serious chronic medical or psychiatric illnesses.
- History of significant head trauma, alcohol or substance abuse or other medical illnesses that could cause a neurological deficit (e.g., cerebro-vascular disease) .
- Chronic medication use that, in the opinion of the Investigator, may influence or bias the clinical outcome of the trial.
- Individuals will be excluded from participation in this trial if they are judged by the Principal Investigator as having a significant impairment in their capacity for judgment or reasoning that compromise their ability to make decisions in their best interest.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01482052
Start Date
November 1 2011
End Date
January 1 2013
Last Update
January 14 2013
Active Locations (1)
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1
Kings Cardiology Group
Hanford, California, United States, 93230