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| Sponsored by: |
Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00422292 |
Purpose
This is a modified single-blind, randomized, parallel-group, comparative, multicenter study to test Menactra vaccine in toddlers.
Primary Objectives:
Observational Objectives:
Safety
Immunogenicity:
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
| Enrollment: | 1664 |
| Study Start Date: | December 2006 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Biological: Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
0.5 mL dose, IM
|
| 2: Experimental |
Biological: Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
0.5 mL dose, IM
|
| 3: Experimental |
Biological: Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
0.5 Ml dose, IM
|
| 4: Active Comparator |
Biological: Measles, Mumps, Rubella and Varicella
0.5 mL dose, SC
|
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
Eligibility| Ages Eligible for Study: | 9 Months to 12 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria :
Exclusion Criteria :
Contacts and Locations| 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 |
More Information
| Responsible Party: | Sanofi Pasteur, Inc ( Medical Monitor ) |
| Study ID Numbers: | MTA37 |
| Study First Received: | January 12, 2007 |
| Last Updated: | April 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00422292 History of Changes |
| 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 Paramyxoviridae Infections Measles Meningitis, Bacterial Haemophilus Influenzae Meningitis, Meningococcal Central Nervous System Diseases Chickenpox Meningococcal Infection Healthy Rubella |
Togaviridae Infections Gram-Negative Bacterial Infections Meningitis Herpesviridae Infections Virus Diseases Central Nervous System Infections Meningococcal Infections Influenza, Human DNA Virus Infections Mumps Neisseriaceae Infections |
|
Bacterial Infections Herpes Zoster RNA Virus Infections Morbillivirus Infections Paramyxoviridae Infections Measles Meningitis, Bacterial Nervous System Diseases Meningitis, Meningococcal Central Nervous System Diseases Chickenpox Rubella |
Togaviridae Infections Gram-Negative Bacterial Infections Meningitis Herpesviridae Infections Virus Diseases Rubivirus Infections Central Nervous System Infections Meningococcal Infections Central Nervous System Bacterial Infections DNA Virus Infections Neisseriaceae Infections Mononegavirales Infections |