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| Sponsor: | 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 - 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 |
|---|---|---|
|
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 |
|
Mouth Diseases Bacterial Infections Morbillivirus Infections Measles Meningitis, Meningococcal Rubella Meningitis Gram-Negative Bacterial Infections Rubivirus Infections Parotid Diseases Meningococcal Infections Central Nervous System Bacterial Infections Salivary Gland Diseases Neisseriaceae Infections Herpes Zoster |
RNA Virus Infections Paramyxoviridae Infections Nervous System Diseases Meningitis, Bacterial Rubulavirus Infections Chickenpox Central Nervous System Diseases Togaviridae Infections Herpesviridae Infections Virus Diseases Central Nervous System Infections DNA Virus Infections Stomatognathic Diseases Mumps Parotitis |