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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00258856
First Posted: November 28, 2005
Last Update Posted: February 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):

Primary Outcome Measures:
  • Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination. [ Time Frame: 7 or 14 days post-vaccination ]

    Groups 1 and 2 received booster vaccination; Groups 3 and 4 received primary vaccination.

    Serum bactericidal activity for the Menactra® meningococcal serogroups A, C, Y, and W-135 were at pre-vaccination for all Groups, and at 7 days (Groups 1 and 3), and 14 days (Groups 2 and 4) post-vaccination.



Enrollment: 234
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
Experimental: Menactra® Group 1
Participants who had received Menactra® in Study 603-02. They will provide serum sample before vaccination and on Day 3 and Day 7 after booster vaccination.
Biological: Polysaccharide Diphtheria Conjugate Vaccine
0.5 mL, Intramuscular
Other Name: Menactra®
Experimental: Menactra® Group 2
Participants who had received Menactra® in Study 603-02. They will provide serum sample before vaccination and on Day 5 and Day 14 after booster vaccination.
Biological: Polysaccharide Diphtheria Conjugate Vaccine
0.5 mL, Intramuscular
Other Name: Menactra®
Experimental: Meningococcal Vaccine-naïve Group 3
Participants who have never received a Meningococcal vaccine in the past. They will provide serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.
Biological: Polysaccharide Diphtheria Conjugate Vaccine
0.5 mL, Intramuscular
Other Name: Menactra®
Experimental: Meningococcal Vaccine-naïve Group 4
Participants who have never received a Meningococcal vaccine in the past. They will provide serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination.
Biological: Polysaccharide Diphtheria Conjugate Vaccine
0.5 mL, Intramuscular
Other Name: Menactra®

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Pasteur, a Sanofi Company
Investigators
Study Director: Medical Monitor Sanofi Pasteur Inc.
  More Information

Additional Information:
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00258856     History of Changes
Other Study ID Numbers: MTA23
First Submitted: November 24, 2005
First Posted: November 28, 2005
Results First Submitted: October 19, 2009
Results First Posted: November 25, 2009
Last Update Posted: February 14, 2014
Last Verified: January 2014

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Meningitis
Meningococcal infection
Neisseria meningitidis
Menactra®
Menomune®

Additional relevant MeSH terms:
Meningitis
Meningococcal Infections
Central Nervous System Diseases
Nervous System Diseases
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Antibodies
Immunologic Factors
Physiological Effects of Drugs