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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00384397 |
This is a Phase III, modified single-blind, randomized, parallel-group, multicenter, comparative trial in the United States designed to evaluate the immunogenicity and safety of two doses of Menactra vaccine administered alone, and concomitantly with other routine pediatric vaccines typically administered between 12 and 15 months of age.
Primary Objective:
To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W 135.
Secondary Objectives:
Immunogenicity
Safety
- To describe the safety profile within 7 and 30 days of each vaccination, and serious adverse events [SAEs] throughout the course of the study.
Condition | Intervention | Phase |
---|---|---|
Meningococcal Meningitis Measles Mumps Rubella Varicella |
Biological: Polysaccharide Diphtheria Conjugate Vaccine Biological: Meningococcal Polysaccharide Diphtheria Conjugate |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Enrollment: | 1128 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | November 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Menactra vaccine at age 12 months
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Biological: Polysaccharide Diphtheria Conjugate Vaccine
0.5 mL, Intramuscular
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2: Experimental
Menactra + MMRV vaccines at age 12 month
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Biological: Meningococcal Polysaccharide Diphtheria Conjugate
0.5 mL, Intramuscular
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3: Experimental
Menactra + PCV vaccines at age 12 months
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Biological: Meningococcal Polysaccharide Diphtheria Conjugate
0.5 mL, Intramuscular
|
Ages Eligible for Study: | 249 Days to 291 Days |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Medical Monitor | Sanofi Pasteur Inc. |
Responsible Party: | Sanofi Pasteur Inc. ( Medical Monitor ) |
Study ID Numbers: | MTA44 |
Study First Received: | October 5, 2006 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00384397 |
Health Authority: | United States: Food and Drug Administration |
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 |