A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers
NCT ID: NCT00384397
Last Updated: 2016-04-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1128 participants
INTERVENTIONAL
2006-09-30
2009-02-28
Brief Summary
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Primary Objective:
To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135.
Secondary Objectives:
Immunogenicity
* To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, when Menactra vaccine is administered alone or concomitantly with Hib and MMRV vaccines.
* To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, when Menactra vaccine is administered alone or concomitantly with PCV vaccine.
Safety
\- To describe the safety profile within 7 and 30 days of each vaccination, and serious adverse events (SAEs) throughout the course of the study.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Group 1: Menactra® Vaccine
Participants will receive Menactra® vaccine at age 9 months and 12 months, respectively.
Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine
0.5 mL, Intramuscular
Group 2: Menactra® + MMRV
Participants will receive Menactra® at age 9 months followed by Menactra® and Measles-Mumps-Rubella-Varicella (MMRV) vaccines at Age 12 Months
Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Group 3: Menactra® + PCV
Participants will receive Menactra® at age 9 months followed by Menactra® and Pneumococcal Conjugate (PCV) vaccines at Age 12 Months
Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Interventions
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Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine
0.5 mL, Intramuscular
Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged 9 months (249 to 291 days) at the time of enrollment.
* The parent or legal guardian has signed and dated the Institutional Review Board-approved informed consent form
Exclusion Criteria
* Known or suspected impairment of immunologic function.
* Acute medical illness within the last 72 hours, or temperature ≥ 100.4 ºF (≥ 38.0 ºC) at the time of enrollment.
* History of documented invasive meningococcal disease or previous meningococcal vaccination.
* Known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C seropositivity as reported by the parent or legal guardian
* Received either immune globulin or other blood products within the last 3 months, or received injected or oral corticosteroids, or other immunomodulator therapy within 6 weeks of the study vaccines. Individuals on a tapering dose schedule of oral steroids lasting \< 7 days and individuals (e.g., asthmatics) on a short schedule of oral steroids lasting 3 to 4 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. Topical steroids are not included in this exclusion criterion.
* Anticipated to receive oral or injected antibiotic therapy within the 72 hours prior to the study blood draw. Topical antibiotics or antibiotic drops are not included in this exclusion criterion.
* Suspected or known hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the study vaccines or a vaccine containing the same substances. For ProQuad vaccine recipients, this includes a hypersensitivity to gelatin or a history of anaphylactic reactions to neomycin.
* Thrombocytopenia or a bleeding disorder contraindicating intramuscular (IM) vaccination.
* Parent or legal guardian unable or unwilling to comply with the study procedures.
* Participation in another interventional clinical trial in the 30 days preceding enrollment, or participation in another clinical trial involving the investigation of a drug, vaccine, medical procedure, or medical device during the subject's trial period.
* Diagnosed with 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.
* Received any vaccine in the 30-day period prior to receipt of study vaccine, or scheduled to receive any vaccination other than influenza vaccination and hyposensitization therapy in the 30-day period after receipt of any study vaccine. Hyposensitization therapy and influenza vaccination may be received up to two weeks before or two weeks after receiving the study vaccines. Subjects should not have received their 4th dose of Pneumococcal Conjugate (PCV) or Hib vaccine or their first dose of Measles-Mumps-Rubella-Varicella (MMRV) vaccine before enrollment.
* Personal or family history of Guillain-Barré Syndrome (GBS).
* History of seizures, including febrile seizures, or any other neurologic disorder.
* Known hypersensitivity to dry natural rubber latex (pertinent to the Menactra® vaccine needle shield)
249 Days
305 Days
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 Monitor
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc.
Locations
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Montgomery, Alabama, United States
Fayetteville, Arkansas, United States
Jonesboro, Arkansas, United States
Little Rock, Arkansas, United States
Little Rock, Arkansas, United States
Norwich, Connecticut, United States
Cocoa Beach, Florida, United States
Viera, Florida, United States
Atlanta, Georgia, United States
Marietta, Georgia, United States
Bardstown, Kentucky, United States
Woburn, Massachusetts, United States
Bridgeton, Missouri, United States
St Louis, Missouri, United States
Las Vegas, Nevada, United States
Rochester, New York, United States
Syracuse, New York, United States
Chapel Hill, North Carolina, United States
Goldsboro, North Carolina, United States
Laurinburg, North Carolina, United States
Sylva, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Tulsa, Oklahoma, United States
Pittsburgh, Pennsylvania, United States
Sellersville, Pennsylvania, United States
Kingsport, Tennessee, United States
Fort Worth, Texas, United States
Layton, Utah, United States
Ogden, Utah, United States
Pleasant Grove, Utah, United States
Provo, Utah, United States
Salt Lake City, Utah, United States
Charlottesville, Virginia, United States
Midlothian, Virginia, United States
Norfolk, Virginia, United States
Spokane, Washington, United States
La Crosse, Wisconsin, United States
Countries
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Related Links
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Related Info
Other Identifiers
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MTA44
Identifier Type: -
Identifier Source: org_study_id
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