Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Children Aged 12-59 Months.
NCT ID: NCT00310817
Last Updated: 2015-11-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
623 participants
INTERVENTIONAL
2005-03-31
2006-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PREVENTION
DOUBLE
Study Groups
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MenACWY-CRM(Ad+) 12 to 35 Months
Subjects received one dose of MenACWY-CRM conjugate vaccine with adjuvant (Ad+) on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
MenACWY-CRM conjugate vaccine, adjuvanted
MenACWY-CRM(Ad-) 12 to 35 Months
Subjects received one dose of MenACWY-CRM conjugate vaccine without adjuvant (Ad-) on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
MenACWY-CRM conjugate vaccine, unadjuvanted
MenACWY-CRM(Ad-) 36 to 59 Months
Subjects received one dose of MenACWY-CRM conjugate vaccine without adjuvant on day 1 and second dose on day 169 or day 337.
MenACWY-CRM conjugate vaccine, unadjuvanted
MenACWY-PS (36 to 59 Months)
Subjects received one dose of MenACWY polysaccharide (PS) vaccine on day 1 and second dose of MenACWY-CRM conjugate vaccine without adjuvant on day 169 or day 337.
MenACWY polysaccharide vaccine
Interventions
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MenACWY-CRM conjugate vaccine, adjuvanted
MenACWY polysaccharide vaccine
MenACWY-CRM conjugate vaccine, unadjuvanted
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* subjects with any serious acute or chronic progressive disease
12 Months
59 Months
ALL
Yes
Sponsors
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Novartis
INDUSTRY
Novartis Vaccines
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Vaccines - Drug Information Services
Role: STUDY_CHAIR
Novartis
Locations
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University of Tampere Medical School
Tampere, , Finland
Oddz. Neuroinfekcji, Szpital Jana Pawla II, Krakow
Samodzielny ZOZ, Lubartów, , Poland
Countries
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Other Identifiers
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EUDRACT NUMBER: 2004-001896-21
Identifier Type: -
Identifier Source: secondary_id
V59P7
Identifier Type: -
Identifier Source: org_study_id
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