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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00422292 |
This is a modified single-blind, randomized, parallel-group, comparative, multicenter study to test Menactra vaccine in toddlers.
Primary Objectives:
Observational Objectives:
Safety - To describe the safety profile throughout the course of the study from Day 0 up to 6 months after the last study vaccination[s]) in subjects in the study groups.
Immunogenicity:
- To describe the antibody responses to meningococcal serogroups A, C, Y, and W-135, 30 days after the first and second Menactra vaccine administration in a subset of subjects in the first study group.
Condition | Intervention | Phase |
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Meningococcal Meningitis Measles Mumps Rubella Varicella |
Biological: Meningococcal Polysaccharide Diphtheria Conjugate Vaccine Biological: Measles, Mumps, Rubella and Varicella |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 1852 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Biological: Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
0.5 mL dose, IM
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2: Experimental |
Biological: Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
0.5 mL dose, IM
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3: Experimental |
Biological: Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
0.5 Ml dose, IM
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4: Active Comparator |
Biological: Measles, Mumps, Rubella and Varicella
0.5 mL dose, SC
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No meningococcal vaccine is presently licensed for the population aged < 2 years in the US, establishing the effectiveness of a quadrivalent polysaccharide conjugate vaccine against invasive meningococcal disease in children aged < 2 years would address this important, currently unmet public health need.
At enrollment, each 9-month old subject will be randomly assigned to a study group and vaccinated. A second vaccination will be administered at 12 months of age. Subjects will provide one blood sample during the trial.
Twelve-month old subjects will also be vaccinated with routine pediatric vaccines and provide one blood sample 30 days after vaccinations in the control group
Ages Eligible for Study: | 9 Months to 12 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria :
Exclusion Criteria :
United States, California | |
Paramount, California, United States, 90723 | |
United States, Nebraska | |
Omaha, Nebraska, United States, 68131 | |
United States, New York | |
Poughkeepsie, New York, United States, 12603 | |
United States, North Carolina | |
Sylva, North Carolina, United States, 28779 | |
United States, Ohio | |
Cincinnati, Ohio, United States, 45245 | |
United States, Pennsylvania | |
Pittsburgh, Pennsylvania, United States, 15241 | |
Hershey, Pennsylvania, United States, 17033 | |
United States, Texas | |
San Antonio, Texas, United States, 78229 | |
Dallas, Texas, United States, 75234 | |
United States, Utah | |
Ogden, Utah, United States, 84405 | |
Salt Lake City, Utah, United States, 84123 | |
St. George, Utah, United States, 84790 | |
United States, Wisconsin | |
Marshfield, Wisconsin, United States, 54449 |
Study Director: | Clinical Trials | sanofi pasteur |
Responsible Party: | Sanofi Pasteur, Inc ( Medical Monitor ) |
Study ID Numbers: | MTA37 |
Study First Received: | January 12, 2007 |
Last Updated: | August 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00422292 |
Health Authority: | United States: Food and Drug Administration |
Menactra vaccine Meningococcal meningitis Measles Mumps |
Rubella Varicella vaccines Haemophilus influenzae type b Pneumococcal conjugate vaccine |
Bacterial Infections Herpes Zoster Haemophilus influenzae Paramyxoviridae Infections Measles Meningitis, Bacterial Meningitis, Meningococcal Central Nervous System Diseases Chickenpox Healthy Rubella Togaviridae Infections |
Meningococcal infection Gram-Negative Bacterial Infections Meningitis Herpesviridae Infections Virus Diseases Central Nervous System Infections Meningococcal Infections Influenza, Human DNA Virus Infections Chicken pox Mumps Neisseriaceae Infections |
Rubivirus Infections RNA Virus Infections Morbillivirus Infections |
Nervous System Diseases Central Nervous System Bacterial Infections Mononegavirales Infections |