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Persistence of Antibodies in Children Aged 7 to 15 Years Who Previously Received One Dose of Menactra® or Menomune®

This study has been completed.

Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00258856
  Purpose

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
Biological: Polysaccharide Diphtheria Conjugate Vaccine
Phase II

MedlinePlus related topics:   Diphtheria    Meningitis   

ChemIDplus related topics:   Meningococcal Vaccines   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Persistence of Bactericidal Antibodies in Children Aged 7 to 15 Years Who Received a Single Dose of Menactra® or Menomune®-A/C/Y/W-135 Five Years Earlier

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • To describe immunogenicity (Approximately 5 years after Menactra® or Menomune®-A/C/Y/W-135 vaccine [ Time Frame: 5 years post vaccination ] [ Designated as safety issue: No ]

Enrollment:   487
Study Start Date:   January 2006
Study Completion Date:   November 2007
Primary Completion Date:   March 2007 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental Biological: Polysaccharide Diphtheria Conjugate Vaccine
0.5 mL, I.M.
2: Experimental Biological: Polysaccharide Diphtheria Conjugate Vaccine
0.5 mL, I.M.
3: Experimental Biological: Polysaccharide Diphtheria Conjugate Vaccine
0.5 mL, I.M.
4: Experimental Biological: Polysaccharide Diphtheria Conjugate Vaccine
0.5 mL, I.M.

  Eligibility
Ages Eligible for Study:   7 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00258856

Locations
United States, Arkansas
      Jonesboro, Arkansas, United States, 72401
      Little Rock, Arkansas, United States, 72205
United States, Georgia
      Marietta, Georgia, United States, 30062
United States, Maryland
      Baltimore, Maryland, United States, 21201-1559
United States, Massachusetts
      Woburn, Massachusetts, United States, 01801
United States, Missouri
      Bridgeton, Missouri, United States, 63044
United States, New York
      Rochester, New York, United States, 14620
United States, Pennsylvania
      Pittsburgh, Pennsylvania, United States, 15241
      Sellersville, Pennsylvania, United States, 18960
United States, Utah
      Salt Lake City, Utah, United States, 84123
United States, Virginia
      Norfolk, Virginia, United States, 23510

Sponsors and Collaborators
Sanofi-Aventis

Investigators
Study Director:     Medical Monitor     Sanofi Pasteur Inc.    
  More Information


Related Info  This link exits the ClinicalTrials.gov site
 
Related Info  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Sanofi Pasteur, Inc. ( Medical Monitor )
Study ID Numbers:   MTA23
First Received:   November 24, 2005
Last Updated:   September 24, 2008
ClinicalTrials.gov Identifier:   NCT00258856
Health Authority:   United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:
Meningitis  
Meningococcal infection  
Neisseria meningitidis  
Menactra®  
Menomune®  

Study placed in the following topic categories:
Bacterial Infections
Antibodies
Central Nervous System Infections
Meningococcal Infections
Central Nervous System Diseases
Neisseria meningitidis
Meningococcal infection
Gram-Negative Bacterial Infections
Neisseriaceae Infections
Meningitis

Additional relevant MeSH terms:
Nervous System Diseases
Infection

ClinicalTrials.gov processed this record on October 06, 2008




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