The study is designed to evaluate the persistence of bactericidal antibodies in subjects aged 7 to 15 years (not yet 16 years) who had been vaccinated five years previously in Study 603-02. In addition, the kinetics of the antibody response will be evaluated in a subset of participants who will receive a booster dose of Menactra® vaccine and children in the same age group not previously vaccinated with a meningococcal vaccine or had meningitis disease who will receive a dose of Menactra® vaccine.

Condition	Intervention	Phase
Meningitis Meningococcal Infection	Vaccine: Menactra®: Polysaccharide Diphtheria Conjugate Vaccine	Phase IV

Further study details as provided by Sanofi-Aventis:

Ages Eligible for Study:  7 Years   -   15 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• Subject is healthy, as determined by medical history.
• Subject is between the ages of 7 and 15 years (not yet 16 years).
• For subjects who participated in Study 603-02, subject previously received one dose of Menactra® vaccine or Menomune®-A/C/Y/W-135 vaccine.
• The date of vaccination during Study 603-02 will have occurred 5 years ± 6 months before the collection of the blood sample obtained for Study MTA23.
• A negative urine pregnancy test is required for menstruating female subjects.
• Parent/legal guardian has signed an Institutional Review Board (IRB)-approved informed consent form and subject has signed an IRB-approved assent form.

Exclusion Criteria:

• Subjects who participated in sanofi pasteur Study MTA17 Stage I (a subset of subjects from Study 603-02 who had been recruited for the follow-up challenge study)
• History of documented invasive meningococcal disease
• Received any other meningococcal vaccine
• Received any vaccine in the 28-day period prior to enrollment
• Received antibiotic therapy within the 72 hours prior to collection of a blood sample
• Actively enrolled or scheduled to be enrolled in another clinical study
• Serious chronic disease (i.e., cardiac, renal, neurologic, rheumatologic, metabolic, gastrointestinal, psychiatric, or other organ system)
• Known or suspected impairment of immunologic function
• Acute medical illness with or without fever within 72 hours or an oral temperature >= 100.4°F (>= 38.0°C) at the time of inclusion
• Scheduled to receive any vaccination in the 7-day or 14-day period after enrollment
• Administration of immune globulin, other blood products, or corticosteroid within 8 weeks (56 days) of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting < 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
• Personal of family history of Guillain-Barres Syndrome
• 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
• Any condition which, in the opinion of the investigator, would pose a health risk to the participant.

Please refer to this study by ClinicalTrials.gov identifier  NCT00258856

Public Registry Sanofi Pasteur       RegistryContactUs@sanofipasteur.com

Arkansas
      Jonesboro,  Arkansas,  United States
      Little Rock,  Arkansas,  United States
Georgia
      Marietta,  Georgia,  United States
Maryland
      Baltimore,  Maryland,  United States
Massachusetts
      Woburn,  Massachusetts,  United States
Missouri
      Bridgeton,  Missouri,  United States
New York
      Rochester,  New York,  United States
Pennsylvania
      Pittsburgh,  Pennsylvania,  United States
      Sellersville,  Pennsylvania,  United States
Utah
      Salt Lake City,  Utah,  United States
Virginia
      Norfolk,  Virginia,  United States

Study ID Numbers:  MTA23
Last Updated:  December 8, 2005
Record first received:  November 24, 2005
ClinicalTrials.gov Identifier:  NCT00258856
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10