Status:
TERMINATED
Antibody Responses Following Meningococcal Tetravalent (A, C, Y, and W-135) Conjugate Vaccination in Healthy Adults
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Meningitis
Meningococcemia
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
This study was designed to generate data for the assessment of Meningococcal Polysaccharide Diphtheria Toxoid Conjugate vaccine (Menactra®) when given to adults aged 18 to 55 years. Primary Objective...
Detailed Description
Enrollment was terminated before the planned sample size was achieved because the principal investigator and the Sponsor decided that sufficient sera had been obtained to meet the secondary objective ...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- Participant was at least 18 years of age but not yet 56 years of age at the time of vaccination.
- Participant had received either unconjugated meningococcal polysaccharide (serogroups A and C, or A, C, Y, and W 135) vaccine at least one year prior to enrollment (for assignment to Group 2) or had no prior history of meningococcal vaccination (for assignment to Group 1).
- Participant had signed Ethics Committee-approved informed consent form.
- Exclusion Criteria :
- Serious chronic disease (i.e., cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, etc.)
- Known or suspected impairment of immunologic function
- Acute medical illness with or without fever within the last 72 hours or an oral temperature ≥ 38°C at the time of inclusion
- History of documented invasive meningococcal disease
- Administration of immune globulin or other blood products within the last three months, or injected or oral corticosteroids or other immunomodulatory therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting \< 7 days were allowed to be included in the trial as long as they had not received more than one course within the last two weeks prior to enrollment.
- Antibiotic therapy within the 72 hours prior to vaccination or 72 hours prior to drawing the blood sample at Visit 2
- Received unconjugated meningococcal polysaccharide (serogroups A and C, or A, C, Y, and W 135) vaccine within the one-year period prior to enrollment or a conjugated meningococcal vaccine at any time prior to enrollment
- Received any vaccine in the 28-day period prior to enrollment, or scheduled to receive any vaccination during participation in the study
- Suspected or known hypersensitivity to any of the vaccine components
- Unavailable for the entire study period, or unable to attend the scheduled visits or to comply with the study procedures
- Enrolled in another clinical trial
- In females, pregnancy confirmed by positive urine test result
- In females, current breastfeeding.
Exclusion
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2004
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00772629
Start Date
January 1 2004
End Date
April 1 2004
Last Update
February 14 2014
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Bristol, United Kingdom
2
London, United Kingdom