Study of a Tetravalent Meningococcal Diphtheria Toxoid Conjugate Vaccine in Toddlers 9 to 18 Months of Age
Safety and Immunogenicity of a Tetravalent (A, C, Y, and W-135) Meningococcal Diphtheria Toxoid Conjugate Vaccine (TetraMenD) In Toddlers 9 to 18 Months of Age
1 other identifier
interventional
378
1 country
14
Brief Summary
The purpose of this clinical trial is to describe the safety and immunogenicity of one or two doses of Menactra® (TetraMenD) administered in children less than 2 years of age. Primary Objective: To describe the immunogenicity profile of one or two doses of Menactra® (TetraMenD) when administered to subjects aged 9, 12, 15, or 18 months in comparison to the immunogenicity of one dose of Menomune® when administered to children aged 3 years to \<6 years of age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2004
Typical duration for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 24, 2008
CompletedFirst Posted
Study publicly available on registry
March 26, 2008
CompletedResults Posted
Study results publicly available
January 8, 2010
CompletedFebruary 14, 2014
January 1, 2014
1.2 years
March 24, 2008
September 24, 2009
January 21, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination.
Day 0 (baseline) and Day 28 post-Vaccinations 1 and 2
Other Outcomes (1)
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Day 0 up to 7 post-vaccination
Study Arms (6)
Vaccinated at Age 9 and 12 Months
EXPERIMENTALParticipants received Menactra® vaccine at 9 and 12 Months of age
Vaccinated at Age 9 and 15 Months
EXPERIMENTALParticipants received Menactra® vaccine at 9 and 15 Months of age
Vaccinated at Age 12 and 15 Months
EXPERIMENTALParticipants received Menactra® vaccine at Age 12 and 12 Months of age
Vaccinated at Age 15 Months
EXPERIMENTALParticipants received Menactra® vaccine at 15 Months of age
Vaccinated at Age 18 Months
EXPERIMENTALParticipants received Menactra® vaccine at 18 Months of age
Vaccinated at Age 3 Years to <6 Years
ACTIVE COMPARATORParticipants received Menomune® vaccine at Age 3 years to \<6 years of age
Interventions
0.5 mL, Intramuscular (at age 9 and 12 months)
0.5 mL, Subcutaneous (at 3 years to \<6 years of age)
Eligibility Criteria
You may qualify if:
- Informed consent form that has been approved by the site's Institutional Review Board (IRB) and signed by the parent or legal guardian
- Able to attend all scheduled visits and to comply with all trial procedures
You may not qualify if:
- History of a serious chronic disease that could interfere with trial conduct or completion.
- Known or suspected impairment of immunologic function.
- History of invasive meningococcal disease (confirmed either clinically, serologically or microbiologically) or previous meningococcal vaccination.
- Administration of immune globulin or other blood products within 3 months, or oral or parenteral corticosteroids or other immunosuppressive therapy within the last 6 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 having any blood sample drawn.
- Received or scheduled to receive any vaccine in the 28-day period prior to receipt of either dose of the study vaccine, or scheduled to receive any vaccination other than influenza vaccination and hyposensitization therapy in the 28-day period after receipt of either dose of the study vaccine. Hyposensitization therapy and influenza vaccination may be received up to two weeks before or after receiving the trial vaccine.
- Suspected or known hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
- Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
- Unable to attend one or more of the scheduled visits or to comply with the study procedures.
- Participation in another clinical trial in the 4 weeks preceding enrollment.
- Planned participation in another clinical trial during the present trial period.
- Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Unknown Facility
Little Rock, Arkansas, 72205, United States
Unknown Facility
Norwich, Connecticut, 06360, United States
Unknown Facility
Atlanta, Georgia, 30322, United States
Unknown Facility
Marietta, Georgia, 30062, United States
Unknown Facility
Bardstown, Kentucky, 40004, United States
Unknown Facility
Baltimore, Maryland, 21201, United States
Unknown Facility
Woburn, Massachusetts, 01801, United States
Unknown Facility
Akron, Ohio, 44308, United States
Unknown Facility
Columbus, Ohio, 43205, United States
Unknown Facility
Drexel Hill, Pennsylvania, 19026, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15241, United States
Unknown Facility
Sellersville, Pennsylvania, 18960, United States
Unknown Facility
Kingsport, Tennessee, 37664, United States
Unknown Facility
Salt Lake City, Utah, 84123, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Sanofi Pasteur Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2008
First Posted
March 26, 2008
Study Start
December 1, 2004
Primary Completion
March 1, 2006
Study Completion
October 1, 2007
Last Updated
February 14, 2014
Results First Posted
January 8, 2010
Record last verified: 2014-01