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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00483574 |
This clinical trial will evaluate the safety of two injections of Menactra® Vaccine in subjects aged 9 months and at 12 months when the second dose is given concomitantly with other pediatric vaccines routinely administered in the US.
Safety Objective:
To describe the safety profile of two doses of Menactra® Vaccine.
Condition | Intervention | Phase |
---|---|---|
Meningococcal Meningitis Measles Mumps Rubella Varicella |
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Biological: Routine pediatric vaccines |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
Estimated Enrollment: | 1820 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, IM at age 9 and 12 months
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2: No Intervention |
Biological: Routine pediatric vaccines
At 12 months of age
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Ages Eligible for Study: | 9 Months to 12 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria :
Exclusion Criteria :
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.
United States, New York | |
Liverpool, New York, United States, 13088 | |
United States, Texas | |
Galveston, Texas, United States, 77555 | |
Amarillo, Texas, United States, 79124 | |
Chile | |
Santiago de Chile, Chile |
Study Director: | Medical Director | Sanofi Pasteur Inc |
Responsible Party: | Sanofi Pasteur Inc ( Medical Monitor ) |
Study ID Numbers: | MTA48 |
Study First Received: | June 6, 2007 |
Last Updated: | October 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00483574 |
Health Authority: | United States: Food and Drug Administration; Chile: Instituto de Salud Publica de Chile |
Menactra vaccine Meningococcal meningitis Measles Mumps |
Rubella Varicella virus 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 |