Study of a Tetravalent Meningococcal Diphtheria Toxoid Conjugate Vaccine in Toddlers 9 to 18 Months of Age
NCT ID: NCT00643916
Last Updated: 2014-02-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
378 participants
INTERVENTIONAL
2004-12-31
2007-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Vaccinated at Age 9 and 12 Months
Participants received Menactra® vaccine at 9 and 12 Months of age
Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
0.5 mL, Intramuscular (at age 9 and 12 months)
Vaccinated at Age 9 and 15 Months
Participants received Menactra® vaccine at 9 and 15 Months of age
Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
0.5 mL, Intramuscular (at age 9 and 15 months)
Vaccinated at Age 12 and 15 Months
Participants received Menactra® vaccine at Age 12 and 12 Months of age
Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
0.5 mL, Intramuscular (at age 12 and 15 months)
Vaccinated at Age 15 Months
Participants received Menactra® vaccine at 15 Months of age
Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
0.5 mL, Intramuscular (at age 15 months)
Vaccinated at Age 18 Months
Participants received Menactra® vaccine at 18 Months of age
Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
0.5 mL, Intramuscular (at age 18 months)
Vaccinated at Age 3 Years to <6 Years
Participants received Menomune® vaccine at Age 3 years to \<6 years of age
A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)
0.5 mL, Subcutaneous (at 3 years to \<6 years of age)
Interventions
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Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
0.5 mL, Intramuscular (at age 9 and 12 months)
Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
0.5 mL, Intramuscular (at age 9 and 15 months)
Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
0.5 mL, Intramuscular (at age 12 and 15 months)
Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
0.5 mL, Intramuscular (at age 15 months)
Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
0.5 mL, Intramuscular (at age 18 months)
A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)
0.5 mL, Subcutaneous (at 3 years to \<6 years of age)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
9 Months
5 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc.
Locations
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Little Rock, Arkansas, United States
Norwich, Connecticut, United States
Atlanta, Georgia, United States
Marietta, Georgia, United States
Bardstown, Kentucky, United States
Baltimore, Maryland, United States
Woburn, Massachusetts, United States
Akron, Ohio, United States
Columbus, Ohio, United States
Drexel Hill, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Sellersville, Pennsylvania, United States
Kingsport, Tennessee, United States
Salt Lake City, Utah, United States
Countries
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Related Links
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Related Info
Other Identifiers
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MTA26
Identifier Type: -
Identifier Source: org_study_id
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