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:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00258856
First received: November 24, 2005
Last updated: January 21, 2014
Last verified: January 2014

November 24, 2005
January 21, 2014
January 2006
March 2007   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]

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.

Not Provided
Complete list of historical versions of study NCT00258856 on ClinicalTrials.gov Archive Site
Not Provided
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Persistence of Antibodies in Children Aged 7 to 15 Years Who Previously Received One Dose of Menactra® or Menomune®
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

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Meningitis
  • Meningococcal Infection
Biological: Polysaccharide Diphtheria Conjugate Vaccine
0.5 mL, Intramuscular
Other Name: Menactra®
  • 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.
    Intervention: Biological: Polysaccharide Diphtheria Conjugate Vaccine
  • 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.
    Intervention: Biological: Polysaccharide Diphtheria Conjugate Vaccine
  • 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.
    Intervention: Biological: Polysaccharide Diphtheria Conjugate Vaccine
  • 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.
    Intervention: Biological: Polysaccharide Diphtheria Conjugate Vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
234
November 2007
March 2007   (final data collection date for primary outcome measure)

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.
Both
7 Years to 15 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00258856
MTA23
Yes
Sanofi ( Sanofi Pasteur, a Sanofi Company )
Sanofi Pasteur, a Sanofi Company
Not Provided
Study Director: Medical Monitor Sanofi Pasteur Inc.
Sanofi
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP