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Study of a Booster Dose of Meningococcal Diphtheria Toxoid Conjugate Vaccine in Adolescents

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ClinicalTrials.gov Identifier: NCT00777790
Recruitment Status : Completed
First Posted : October 22, 2008
Results First Posted : March 19, 2009
Last Update Posted : February 14, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description
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Brief Summary:

This study was designed to evaluate the antibody response to a Menactra® booster dose in participants who previously received one dose of Menactra® or Menomune® as adolescents 3 years earlier in Study MTA02.

Primary Objective:

To evaluate the antibody responses to a booster dose of a tetravalent meningococcal diphtheria toxoid conjugate vaccine (Menactra®) in participants who had previously received Menactra® or Menomune® as adolescents in the MTA02 Study and antibody responses to a dose of Menactra® in naive adolescents.


Condition or disease Intervention/treatment Phase
Meningitis Meningococcemia Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Phase 2

Detailed Description:
All subjects were given a single boosting dose of Menactra® to evaluate the kinetics of the response, the magnitude and the avidity of the antibody produced.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 241 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Antibody Responses to a Booster Dose of an Experimental Tetravalent (A, C, Y, and W-135) Meningococcal Diphtheria Toxoid Conjugate Vaccine, Menactra® in Adolescents Who Previously Received Menomune® or Menactra®
Study Start Date : February 2004
Actual Primary Completion Date : April 2004
Actual Study Completion Date : April 2005

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Menactra® Group
Received Menactra® vaccine in Study MTA02
 Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Other Name: Menactra®
Experimental: Menomune® Group
Received Menomune® vaccine in Study MTA02
 Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Other Name: Menactra®
Experimental: Control Group
Meningococcal vaccine-naïve Control Group.
 Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Other Name: Mneactra®


Outcome Measures
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Primary Outcome Measures :
  1. Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. [ Time Frame: Day 0 and 8 and 28 days post-vaccination ]
    Geometric mean titers and their 95% confidence interval of serum bactericidal activity for the 4 vaccine serogroups before vaccination, at 8 days post- and 28 days post-booster dose of Menactra vaccine or a primary dose of Menactra vaccine in the meningococcal vaccine-naïve Control group.


Eligibility Criteria
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Ages Eligible for Study:   13 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria :

  • Participant is healthy, as determined by medical history and physical examination.
  • Participant is at least 13 years of age but not yet 22 years of age at time of enrollment.
  • For the Menactra® and Menomune® groups, participant received one dose of Menactra® or Menomune® in MTA02 trial and completed trial (2 blood samples, contacted for Month 6 safety follow up).
  • For the Control group, participant has no previous history of any meningococcal vaccination.
  • If < 18 years of age, participant has signed Institutional Review Board (IRB) approved informed assent form and his/her parent/legal guardian has signed an IRB-approved informed consent form.
  • If ≥ 18 years of age, participant has signed an IRB-approved informed consent form.
  • Able to provide vaccination log.

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 ≥ 100.4ºF (≥ 38.0ºC) at the time of inclusion.
  • For the Menactra® and Menomune® groups, history of documented invasive meningococcal disease or previous meningococcal vaccination with the exception of meningococcal vaccination given as part of MTA02 trial.
  • For the Control group, history of documented invasive meningococcal disease or previous meningococcal vaccination.
  • Administration of immune globulin, other blood products within the last three months, 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 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.
  • Antibiotic therapy within the 72 hours prior to vaccination or antibiotic therapy within the 72 hours prior to having any blood sample drawn.
  • Received any vaccine in the 14-day period prior to study vaccination, or scheduled to receive any vaccination during the 14-day period after study vaccination.
  • 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.
  • In females, a positive or equivocal urine pregnancy test at the time of vaccination.
  • Enrolled in another clinical trial.
  • Any condition, which, in the opinion of the investigator, would pose a health risk to the participant, or interfere with the evaluation of the vaccine.
Contacts and Locations
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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): NCT00777790


Locations
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United States, Georgia
Atlanta, Georgia, United States, 30322
Marietta, Georgia, United States, 30062
United States, Massachusetts
Woburn, Massachusetts, United States, 01801
United States, New York
Albany, New York, United States, 12208
United States, Ohio
Akron, Ohio, United States, 44308
Columbus, Ohio, United States, 43205
United States, Pennsylvania
Sellersville, Pennsylvania, United States, 18960
United States, Tennessee
Kingsport, Tennessee, United States, 37660
United States, Virginia
Norfolk, Virginia, United States, 23501
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Monitor Sanofi Pasteur Inc.
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00777790    
Other Study ID Numbers: MTA19
First Posted: October 22, 2008    Key Record Dates
Results First Posted: March 19, 2009
Last Update Posted: February 14, 2014
Last Verified: January 2014
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Meningitis
Meningococcemia
Neisseria meningitidis
Additional relevant MeSH terms:
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Meningococcal Infections
Diphtheria
Meningitis
Central Nervous System Diseases
Nervous System Diseases
Neisseriaceae Infections
 Gram-Negative Bacterial Infections
Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections