Immunogenicity of the Booster Dose of Two MenC Vaccines
NCT ID: NCT00392808
Last Updated: 2013-10-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
389 participants
INTERVENTIONAL
2007-01-31
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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MENC-CRM/MENC-CRM
Children primed with 3 doses of MenC-CRM vaccine, Intervention: boosted with one dose of MenC-CRM vaccine
conjugated polysaccharide menC vaccine
Booster vaccine dose at 14 to 18 months.
MENC-CRM/MENC-TT
Children Primed with three doses of MenC-CRM vaccine. Intervention: boosted with one dose of MenC-TT
conjugated polysaccharide menC vaccine
Booster vaccine dose at 14 to 18 months.
MENC-TT/MENC-CRM
Children primovacccinated with two MenC-TT vaccine doses. Intervention: boosted with one dose MenC-CRM vaccine
conjugated polysaccharide menC vaccine
Booster vaccine dose at 14 to 18 months.
MENC-TT/MENC-TT
Children primovacccinated with two MenC-TT vaccine doses. Intervention boosted with one dose MenC-TT vaccine
conjugated polysaccharide menC vaccine
Booster vaccine dose at 14 to 18 months.
Interventions
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conjugated polysaccharide menC vaccine
Booster vaccine dose at 14 to 18 months.
Eligibility Criteria
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Inclusion Criteria
* Toddlers of 14 to 19 months of age (including the day that the toddler is 14 and the day before he is 19 months of age)
* Children previously vaccinated with two doses of polysaccharide meningococcal C vaccine conjugated to tetanus toxoid or three doses of polysaccharide meningococcal C conjugated to CRM197 before 7 month of age.
* Informed consent signed by one or both parents who are adequately informed about the study.
Exclusion Criteria
* Toddlers with severe chronic diseases
* Toddlers who have received any other vaccine within the last month or with a programmed vaccination within the 28 subsequent days after the administration of the vaccine of study.
* Toddlers with clinical or bacteriological diagnosis of previous meningococcal disease.
* Toddlers with hypersensitivity to any of the components of the vaccines to study or antibiotics used during the manufacturing process that could be present as non- detectable traces (streptomycin, neomycin, polymyxin B).
* Toddlers with personal history of convulsions.
* Toddlers with known bleeding disorder no controlled
* Toddlers with known congenital or acquired immunodeficiency
* Toddlers who are receiving or have been received any treatment that could change the immune response (administration of intravenous immunoglobulin, systemic corticosteroids or haemoderivates) within the 3 previous months.
* A toddler that under investigator opinion is probable to be lost during the follow-up
* A toddler that is currently included or is planned to be included in any other clinical trial.
* A toddler that under investigator opinion must not be included in the study due to other medical or social reasons.
14 Months
19 Months
ALL
Yes
Sponsors
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Centro Superior de Investigación en Salud Publica
OTHER_GOV
Responsible Party
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Principal Investigators
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Javier Diez-Domingo, PhD
Role: STUDY_CHAIR
Centro Superior Investigacion Salud Publica (CSISP)
Locations
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Universidad Rey Juan Carlos I
Madrid, , Spain
Centro Superior Investigación en Salud Publica
Valencia, , Spain
Countries
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References
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Diez-Domingo J, Planelles-Cantarino MV, Baldo-Torrenti JM, Ubeda-Sansano I, Jubert-Rosich A, Puig-Barbera J, Gutierrez-Gimeno MV. Antibody persistence 12 months after a booster dose of meningococcal-C conjugated vaccine in the second year of life. Pediatr Infect Dis J. 2010 Aug;29(8):768-70. doi: 10.1097/INF.0b013e3181d9e653.
Diez-Domingo J, Cantarino MV, Torrenti JM, Sansano MI, Rosich AJ, Merino AH, de Miguel AG, Gonzalez JB, Marcos MD; MenC Study Group. A randomized, multicenter, open-label clinical trial to assess the immunogenicity of a meningococcal C vaccine booster dose administered to children aged 14 to 18 months. Pediatr Infect Dis J. 2010 Feb;29(2):148-52. doi: 10.1097/INF.0b013e3181b9a831.
Other Identifiers
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EUDRA 2006-003525-82
Identifier Type: -
Identifier Source: secondary_id
CSISP-VAC-MENC1
Identifier Type: -
Identifier Source: org_study_id