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Study of Reduced Dose of Menomune® in Children Who Previously Received Meningococcal Diphtheria Toxoid Conjugate Vaccine

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ClinicalTrials.gov Identifier: NCT00772070
Recruitment Status : Completed
First Posted : October 15, 2008
Results First Posted : May 14, 2009
Last Update Posted : February 14, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE October 13, 2008
First Posted Date  ICMJE October 15, 2008
Results First Submitted Date  ICMJE March 26, 2009
Results First Posted Date  ICMJE May 14, 2009
Last Update Posted Date February 14, 2014
Study Start Date  ICMJE March 2003
Actual Primary Completion Date August 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2009)
Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination. [ Time Frame: Day 0 and Days 8 and 28 post-vaccination ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 14, 2008)
  • Immunogenicity: To provide information concerning immune response of a tetravalent meningococcal polysaccharide diphtheria conjugate vaccine [ Time Frame: 28 days post vaccination ]
  • Safety: To provide information concerning the safety after administration of a tetravalent meningococcal polysaccharide diphtheria conjugate vaccine [ Time Frame: Entire study duration ]
Change History Complete list of historical versions of study NCT00772070 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: January 21, 2014)
  • Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups. [ Time Frame: Baseline to Day 8 and Day 28 post-vaccination ]
  • Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. [ Time Frame: Day 0 to 7 post-vaccination ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Reduced Dose of Menomune® in Children Who Previously Received Meningococcal Diphtheria Toxoid Conjugate Vaccine
Official Title  ICMJE Antibody Responses to a Reduced Dose of Menomune® in Children Who Previously Received an Experimental Tetravalent (A, C, Y, and W-135) Meningococcal Diphtheria Toxoid Conjugate Vaccine, TetraMenD
Brief Summary

This study was designed to simulate meningococcal challenge by vaccination with a fractional combined dose of unconjugated meningococcal polysaccharides A, C, Y, and W-135, Menomune® in children who were vaccinated with one dose of TetraMenD at least 18 months earlier.

Primary Objective:

To evaluate and compare the antibody responses to a reduced dose of Menomune® in participants who had previously received a tetravalent meningococcal diphtheria toxoid conjugate vaccine to those responses in participants who received the same reduced dose of Menomune® but had not previously received any meningococcal vaccine.

Detailed Description This was a two stage, controlled, open-label trial. Stage I of the trial simulated meningococcal challenge Stage II of the trial evaluated the meningococcal vaccine naïve participants from Stage I, who had also received a reduced dose of Menomune® vaccine in Stage I and were administered a full dose of Menactra® vaccine 6 months later.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Meningitis
  • Meningococcemia
  • Neisseria Meningitidis
Intervention  ICMJE Biological: A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)
0.05 mL, Subcutaneous
Other Name: Menomune®
Study Arms  ICMJE
  • Experimental: Previously received TetraMenD
    Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
    Intervention: Biological: A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)
  • Experimental: Meningococcal vaccine-naїve
    Participants have never received a Meningococcal vaccine in the past.
    Intervention: Biological: A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)
Publications * Pichichero M, Papa T, Blatter M, Mitchell D, Kratz R, Sneed J, Bassily E, Casey J, Gilmet G. Immune memory in children previously vaccinated with an experimental quadrivalent meningococcal polysaccharide diphtheria toxoid conjugate vaccine. Pediatr Infect Dis J. 2006 Nov;25(11):995-1000.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 14, 2008)
173
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2004
Actual Primary Completion Date August 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria :

  • Stage I
  • Participant is healthy, as determined by medical history and physical examination.
  • Participant is at least 3 years of age but not yet 6 years of age at the enrolment.
  • For the TetraMenD group: received one dose of TetraMenD as a participant in trial 603-02 no less than 18 months prior to enrolment
  • For the Control group: no previous history of any meningococcal vaccination
  • Parent/Guardian has signed Institutional Review Board- (IRB-) approved informed consent form.
  • Stage II
  • Participant is healthy, as determined by medical history and physical examination.
  • Participant is at least 3 years of age but not yet 6 years of age at the time of enrollment in Stage 1.
  • Enrolled in the Control group only and received one dose of the reduced dose Menomune at Stage 1.
  • Parent/Guardian has signed Institutional Review Board- (IRB-) approved informed consent form.

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 axillary temperature (≥ 99.5ºF [≥ 37.5ºC]) at the time of inclusion
  • For Stage I, history of documented invasive meningococcal disease or previous meningococcal vaccination with exception of those participants recruited from Trial 603-02.
  • For Stage II, history of documented invasive meningococcal disease or participant did not receive Reduced-dose Menomune® six months prior.
  • 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 28-day period prior to study vaccination, or scheduled to receive any vaccination during the 28-day period after study vaccination in Stage 1 of the trial.
  • 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
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00772070
Other Study ID Numbers  ICMJE MTA17
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Sanofi Pasteur Inc.
PRS Account Sanofi
Verification Date January 2014

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