Antibody Responses Following Meningococcal Tetravalent (A, C, Y, and W-135) Conjugate Vaccination in Healthy Adults
Antibody Responses Following Meningococcal Tetravalent (A, C, Y, and W-135) Conjugate Vaccination in Healthy Adults
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:

 To describe the antibody response to each serogroup prior to, and 4 to 6 weeks following, the
 administration of one dose of the investigational Meningococcal Polysaccharide Diphtheria
 Toxoid Conjugate vaccine (Menactra®), as measured by serum bactericidal activity using baby
 rabbit complement (SBA BR) in participants in each of the two study groups.

 Secondary Objective:

 To collect reference sera for the development and refinement of laboratory assays for the
 measurement of antibody responses to serogroups Y and W 135.
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 of the study.

 There were no safety concerns involved in the decision to stop enrollment. Subjects that were
 enrolled at the time completed the study as per protocol, the last subject last visit was on
 29 April 2004.
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.