Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers
NCT ID: NCT00483574
Last Updated: 2016-05-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1378 participants
INTERVENTIONAL
2007-05-31
2009-04-30
Brief Summary
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Safety Objective:
To describe the safety profile of two doses of Menactra® Vaccine.
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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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Group 1: Menactra® and Routine Pediatric Vaccines
Participants received Menactra® alone at age 9 months and Menactra® concomitantly with routine pediatric vaccines (measles-mumps-rubella-varicella \[MMRV: ProQuad\], pneumococcal conjugate \[PCV\], and hepatitis A \[HepA\]) at age 12 months.
Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, IM at age 9 and 12 months
Measles-mumps-rubella-varicella vaccine
0.5 mL, intramuscular at 12 months of age
Routine paediatric vaccine - Pneumococcal conjugate (PCV)
0.5 mL, Intramuscular at age 12 months
Routine paediatric vaccine - Hepatitis A
0.5 mL, Intramuscular at age 12 months
Group 2: Routine Pediatric Vaccines
Participants received routine pediatric vaccines (measles-mumps-rubella-varicella \[MMRV: ProQuad\], pneumococcal conjugate\[PCV\], and hepatitis A \[HepA\]) at age 12 months.
Measles-mumps-rubella-varicella vaccine
0.5 mL, intramuscular at 12 months of age
Routine paediatric vaccine - Pneumococcal conjugate (PCV)
0.5 mL, Intramuscular at age 12 months
Routine paediatric vaccine - Hepatitis A
0.5 mL, Intramuscular at age 12 months
Interventions
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Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, IM at age 9 and 12 months
Measles-mumps-rubella-varicella vaccine
0.5 mL, intramuscular at 12 months of age
Routine paediatric vaccine - Pneumococcal conjugate (PCV)
0.5 mL, Intramuscular at age 12 months
Routine paediatric vaccine - Hepatitis A
0.5 mL, Intramuscular at age 12 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged 9 months (249 to 305 days) or 12 months (365 to 400 days) at the time of enrollment
* The parent or legal guardian has signed and dated the Independent Ethics Committee (IEC)-/Institutional Review Board (IRB)-approved informed consent form.
Exclusion Criteria
* Known or suspected impairment of immunologic function.
* Acute medical illness within the last 72 hours or a temperature ≥ 100.4ºF (≥ 38.0ºC) at the time of enrollment.
* History of documented invasive meningococcal disease or previous meningococcal vaccination.
* Has received the fourth dose of Prevnar, or the first dose of measles-mumps-rubella (MMR), varicella, or hepatitis A (HepA) vaccine.
* 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.
* Suspected or known hypersensitivity to any of the vaccine components.
* 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 the study vaccine(s), or scheduled to receive any vaccination other than influenza vaccination and hyposensitization therapy in the 30-day period after receipt of the study vaccine(s).
* 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.
For the subjects scheduled to provide blood samples:
\- Anticipated to receive oral or injected antibiotic therapy within the 72 hours prior to either of the study blood draws. Topical antibiotics and antibiotic drops are not included in this exclusion criterion.
9 Months
12 Months
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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Birmingham, Alabama, United States
Birmingham, Alabama, United States
Dothan, Alabama, United States
Pinson, Alabama, United States
Tuscaloosa, Alabama, United States
Chandler, Arizona, United States
Bentonville, Arkansas, United States
Conway, Arkansas, United States
Hardy, Arkansas, United States
Jonesboro, Arkansas, United States
Downy, California, United States
Fountain Valley, California, United States
Huntington Beach, California, United States
Huntington Park, California, United States
La Jolla, California, United States
LaCosta, California, United States
Pico Rivera, California, United States
Centennial, Colorado, United States
Longmont, Colorado, United States
Thornton, Colorado, United States
Lake Mary, Florida, United States
Tampa, Florida, United States
Stone Mountain, Georgia, United States
Boise, Idaho, United States
Evansville, Indiana, United States
Arkansas City, Kansas, United States
Wichita, Kansas, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Louisville, Kentucky, United States
Louisville, Kentucky, United States
Fall River, Massachusetts, United States
Clifton, New Jersey, United States
Endwell, New York, United States
Liverpool, New York, United States
Utica, New York, United States
Garner, North Carolina, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Fargo, North Dakota, United States
Minot, North Dakota, United States
Cincinnati, Ohio, United States
Fairfield, Ohio, United States
Huber Heights, Ohio, United States
Kettering, Ohio, United States
Mason, Ohio, United States
Poland, Ohio, United States
Youngstown, Ohio, United States
Meadowbrook, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Barrington, Rhode Island, United States
Providence, Rhode Island, United States
Warwick, Rhode Island, United States
Barnwell, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Watertown, South Dakota, United States
Bristol, Tennessee, United States
Jackson, Tennessee, United States
Tullahoma, Tennessee, United States
Amarillo, Texas, United States
Amarillo, Texas, United States
Carrollton, Texas, United States
Fort Worth, Texas, United States
Grapevine, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Sugar Land, Texas, United States
Tomball, Texas, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
West Valley City, Utah, United States
Newport News, Virginia, United States
Norfolk, Virginia, United States
Vienna, Virginia, United States
Bellingham, Washington, United States
Santiago, , Chile
Countries
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Related Links
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Related Info
Other Identifiers
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MTA48
Identifier Type: -
Identifier Source: org_study_id
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