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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00772070
First received: October 13, 2008
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Meningitis
Meningococcemia
Neisseria Meningitidis
Biological: A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination. [ Time Frame: Day 0 to 7 post-vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 173
Study Start Date: March 2003
Study Completion Date: May 2004
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Previously received TetraMenD
Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
Biological: A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)
0.05 mL, Subcutaneous
Other Name: Menomune®
Experimental: Meningococcal vaccine-naїve
Participants have never received a Meningococcal vaccine in the past.
Biological: A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)
0.05 mL, Subcutaneous
Other Name: Menomune®

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.

  Eligibility

Ages Eligible for Study:   3 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772070

Locations
United States, Arkansas
Jonesboro, Arkansas, United States, 72401
Little Rock, Arkansas, United States, 72211
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, Virginia
Norfolk, Virginia, United States, 23501
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Monitor Sanofi Pasteur Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00772070     History of Changes
Other Study ID Numbers: MTA17
Study First Received: October 13, 2008
Results First Received: March 26, 2009
Last Updated: January 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Menactra®
Menomune®
Meningitis
Meningococcemia
Neisseria meningitidis

Additional relevant MeSH terms:
Meningitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 01, 2014