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Sponsors and Collaborators: |
Novartis Novartis Vaccines |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00616421 |
This study will evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given to healthy children compared to a licensed Meningococcal ACWY conjugate vaccine
Condition | Intervention | Phase |
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Meningococcal Infections |
Biological: MenACWY |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Subject), Single Group Assignment |
Official Title: | A Phase 3, Randomized, Observer-Blind, Multi-Center Study to Compare the Safety and Immunogenicity of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine With One Dose of Licensed Meningococcal ACWY Conjugate Vaccine Administered to Healthy Children 2-10 Years of Age |
Estimated Enrollment: | 1418 |
Study Start Date: | February 2008 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: Experimental
Children 2-5 years of age, 1 dose of MenACWY
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Biological: MenACWY
1 dose of MenACWY
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3: Active Comparator
Children 2-5 years of age, 1 dose of MenACWY
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Biological: MenACWY
1 dose of MenACWY
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4: Experimental
Children 6-10 years of age, 1 dose of MenACWY
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Biological: MenACWY
1 dose of MenACWY
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5: Active Comparator
Children 6-10 years of age, 1 dose of MenACWY
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Biological: MenACWY
1 dose of MenACWY
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1: Experimental
Children 2-5 years of age, Men ACWY Day 1 and Men ACWY Day 61
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Biological: MenACWY
2 doses of MenACWY
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Ages Eligible for Study: | 2 Years to 10 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study Chair: | Novartis Vaccines | Novartis Vaccines |
Responsible Party: | Novartis Vaccines ( Novartis ) |
Study ID Numbers: | V59P20, 11278 |
Study First Received: | January 31, 2008 |
Last Updated: | March 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00616421 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
vaccine children healthy |
meningitis meningococcal Prevention of Meningococcal disease serogroups ACWY |
Bacterial Infections Meningococcal Infections Healthy Meningococcal Infection |
Gram-Negative Bacterial Infections Neisseriaceae Infections Meningitis |
Bacterial Infections Meningococcal Infections Infection Gram-Negative Bacterial Infections Neisseriaceae Infections |