Study of a Tetravalent Meningococcal Diphtheria Toxoid Conjugate Vaccine in Toddlers 9 to 18 Months of Age
January 21, 2014 updated by: Sanofi Pasteur, a Sanofi Company
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
- Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
- Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
- Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
- Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
- Biological: A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)
Detailed Description
This is a Phase II, open-label, parallel, exploratory, multi-center study in healthy toddlers.
Study Type
Interventional
Enrollment (Actual)
378
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arkansas
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Little Rock, Arkansas, United States, 72205
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Connecticut
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Norwich, Connecticut, United States, 06360
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Georgia
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Atlanta, Georgia, United States, 30322
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Marietta, Georgia, United States, 30062
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Kentucky
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Bardstown, Kentucky, United States, 40004
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Maryland
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Baltimore, Maryland, United States, 21201
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Massachusetts
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Woburn, Massachusetts, United States, 01801
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Ohio
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Akron, Ohio, United States, 44308
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Columbus, Ohio, United States, 43205
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Pennsylvania
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Drexel Hill, Pennsylvania, United States, 19026
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Pittsburg, Pennsylvania, United States, 15241
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Sellersville, Pennsylvania, United States, 18960
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Tennessee
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Kingsport, Tennessee, United States, 37664
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Utah
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Salt Lake City, Utah, United States, 84123
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 months to 5 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria :
- Aged either 9, 12, 15 or 18 months of age or 3 to < 6 years of age on the day of inclusion.
- 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
Exclusion Criteria :
- History of a serious chronic disease that could interfere with trial conduct or completion.
- Known or suspected impairment of immunologic function.
- Acute medical illness with or without fever within the last 72 hours, or rectal temperature ≥ 100.4°F (≥ 38.0°C) or axillary temperature ≥ 99.4°F (≥ 37.4°C) on the day of inclusion.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Vaccinated at Age 9 and 12 Months
Participants received Menactra® vaccine at 9 and 12 Months of age
|
0.5 mL, Intramuscular (at age 9 and 12 months)
Other Names:
0.5 mL, Intramuscular (at age 9 and 15 months)
Other Names:
0.5 mL, Intramuscular (at age 12 and 15 months)
Other Names:
0.5 mL, Intramuscular (at age 15 months)
Other Names:
0.5 mL, Intramuscular (at age 18 months)
Other Names:
|
|
Experimental: Vaccinated at Age 9 and 15 Months
Participants received Menactra® vaccine at 9 and 15 Months of age
|
0.5 mL, Intramuscular (at age 9 and 12 months)
Other Names:
0.5 mL, Intramuscular (at age 9 and 15 months)
Other Names:
0.5 mL, Intramuscular (at age 12 and 15 months)
Other Names:
0.5 mL, Intramuscular (at age 15 months)
Other Names:
0.5 mL, Intramuscular (at age 18 months)
Other Names:
|
|
Experimental: Vaccinated at Age 12 and 15 Months
Participants received Menactra® vaccine at Age 12 and 12 Months of age
|
0.5 mL, Intramuscular (at age 9 and 12 months)
Other Names:
0.5 mL, Intramuscular (at age 9 and 15 months)
Other Names:
0.5 mL, Intramuscular (at age 12 and 15 months)
Other Names:
0.5 mL, Intramuscular (at age 15 months)
Other Names:
0.5 mL, Intramuscular (at age 18 months)
Other Names:
|
|
Experimental: Vaccinated at Age 15 Months
Participants received Menactra® vaccine at 15 Months of age
|
0.5 mL, Intramuscular (at age 9 and 12 months)
Other Names:
0.5 mL, Intramuscular (at age 9 and 15 months)
Other Names:
0.5 mL, Intramuscular (at age 12 and 15 months)
Other Names:
0.5 mL, Intramuscular (at age 15 months)
Other Names:
0.5 mL, Intramuscular (at age 18 months)
Other Names:
|
|
Experimental: Vaccinated at Age 18 Months
Participants received Menactra® vaccine at 18 Months of age
|
0.5 mL, Intramuscular (at age 9 and 12 months)
Other Names:
0.5 mL, Intramuscular (at age 9 and 15 months)
Other Names:
0.5 mL, Intramuscular (at age 12 and 15 months)
Other Names:
0.5 mL, Intramuscular (at age 15 months)
Other Names:
0.5 mL, Intramuscular (at age 18 months)
Other Names:
|
|
Active Comparator: Vaccinated at Age 3 Years to <6 Years
Participants received Menomune® vaccine at Age 3 years to <6 years of age
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0.5 mL, Subcutaneous (at 3 years to <6 years of age)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination.
Time Frame: Day 0 (baseline) and Day 28 post-Vaccinations 1 and 2
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Day 0 (baseline) and Day 28 post-Vaccinations 1 and 2
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Time Frame: Day 0 up to 7 post-vaccination
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Solicited local reactions: Redness, Swelling, and Tenderness.
Solicited systemic reactions: Fever (temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability.
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Day 0 up to 7 post-vaccination
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2004
Primary Completion (Actual)
March 1, 2006
Study Completion (Actual)
October 1, 2007
Study Registration Dates
First Submitted
March 24, 2008
First Submitted That Met QC Criteria
March 25, 2008
First Posted (Estimate)
March 26, 2008
Study Record Updates
Last Update Posted (Estimate)
February 14, 2014
Last Update Submitted That Met QC Criteria
January 21, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Infections
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Corynebacterium Infections
- Neisseriaceae Infections
- Diphtheria
- Meningitis
- Meningococcal Infections
Other Study ID Numbers
- MTA26
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