Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
333 participants
INTERVENTIONAL
2008-06-30
2009-10-31
Brief Summary
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Primary Objective:
To assess, by age group, the immune response to Menactra vaccine after each vaccine injection.
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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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Menactra® Group 1
Participants aged 2 to \< 4 years
Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate
0.5 mL, 2 doses Intramuscular
Menactra® Group 2
Participants aged 4 to \< 6 years
Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate
0.5 mL, 2 doses Intramuscular
Menactra® Group 3
Participants aged 6 to \< 11 years
Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate
0.5 mL, 1 dose Intramuscular
Interventions
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Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate
0.5 mL, 2 doses Intramuscular
Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate
0.5 mL, 2 doses Intramuscular
Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate
0.5 mL, 1 dose Intramuscular
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Provision of assent form signed by the subject (depending on age) and informed consent form signed by the parent(s) or another legally acceptable representative.
* Subject and parent/legal guardian able to attend all scheduled visits and comply with all trial procedures.
Exclusion Criteria
* Participation in the active (i.e., treatment) portion of another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
* Planned participation in another clinical trial during the present trial period.
* Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
* Suspected or known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a product containing any of the substances present in the study vaccine .
* Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
* Receipt of blood or blood-derived products in the past 3 months.
* Received any vaccine (other than desensitization therapy for allergies or influenza vaccine within 2 weeks before vaccination) in the 4 weeks preceding the first trial vaccination.
* Planned receipt of any vaccine within the 4 weeks following any trial vaccination(s).
* Known human immunodeficiency virus (HIV), hepatitis B surface antigen (HBs antigen), or hepatitis C seropositivity.
* History of invasive meningococcal infection (confirmed either clinically, serologically, or microbiologically).
* Thrombocytopenia, coagulation disorder, or anticoagulant use in the 3 weeks preceding inclusion contraindicating intramuscular (IM) vaccination.
* Anticipated to receive oral or injected antibiotic therapy within the 72 hours prior to any of the trial blood draws.
* Personal or family history of Guillain-Barré Syndrome (GBS).
* 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.
2 Years
10 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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Jonesboro, Arkansas, United States
Little Rock, Arkansas, United States
Boca Raton, Florida, United States
Viera, Florida, United States
Woburn, Massachusetts, United States
Las Vegas, Nevada, United States
Cleveland, Ohio, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Kingsport, Tennessee, United States
Fort Worth, Texas, United States
San Antonio, Texas, United States
Orem, Utah, United States
Midlothian, Virginia, United States
Spokane, Washington, United States
Countries
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Related Links
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Related Info
Other Identifiers
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MTA61
Identifier Type: -
Identifier Source: org_study_id
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