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Safety and Immunogenicity of Chiron Meningococcal ACWY Conjugate Vaccine in Healthy Children Aged 12-59 Months.

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00310817
First received: April 3, 2006
Last updated: April 16, 2008
Last verified: April 2008

April 3, 2006
April 16, 2008
March 2005
Not Provided
  • Immune response as measured by serum bactericidal activity of one dose of Men ACWY Ad- with that of a Men ACWY PS vaccine at 28 days following immunization
  • Persistence of functional immune response at 6 or 12 months following administration as measured by GMTs and seroconversion
Not Provided
Complete list of historical versions of study NCT00310817 on ClinicalTrials.gov Archive Site
The booster effect 21 days after a second dose of either Men ACWY Ad+ or Men ACWY Ad- administered at 6 or 12 months after the first dose. Safety and tolerability.
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Safety and Immunogenicity of Chiron Meningococcal ACWY Conjugate Vaccine in Healthy Children Aged 12-59 Months.
A Phase II, Randomized, Observer Blind, Multi-Center, Active Controlled Study to Evaluate the Safety and Immunogenicity of Chiron Meningococcal ACWY Conjugate Vaccine in Healthy Children Aged 12-59 Months.

To compare the functional immune response 28 days after administration of one dose of Men ACWY Ad- with that of a Men ACWY PS vaccine

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Meningococcal Meningitis
Biological: Men ACWY conjugate vaccine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
621
Not Provided
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Inclusion Criteria:

  • healthy 12-<60 month old children;

Exclusion Criteria:

  • who have previously received any meningococcal vaccine
  • subjects with any serious acute or chronic progressive disease
Both
1 Year to 5 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Finland,   Poland
 
NCT00310817
V59P7, EUDRACT NUMBER:2004-001896-21
Not Provided
Not Provided
Novartis
Novartis Vaccines
Study Chair: Novartis Vaccines - Drug Information Services Novartis
Novartis
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP