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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
History of Changes
  Purpose

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


Condition Intervention Phase
Meningococcal Meningitis
 Biological: Men ACWY conjugate vaccine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:

MedlinePlus related topics: Meningitis
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 621
Study Start Date: March 2005
  Eligibility

Ages Eligible for Study:   1 Year to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00310817

Locations
Finland
University of Tampere Medical School
Tampere, Finland
Poland
Oddz. Neuroinfekcji, Szpital Jana Pawla II, Krakow
Samodzielny ZOZ, Lubartów, Poland
Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines - Drug Information Services Novartis
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00310817     History of Changes
Other Study ID Numbers: V59P7, EUDRACT NUMBER:2004-001896-21
Study First Received: April 3, 2006
Last Updated: April 16, 2008
Health Authority: United States: Food and Drug Administration
Finland: Finnish Medicines Agency
Poland: CEBK (Central Register of Clinical Trials)

Keywords provided by Novartis:
meninigitis
children
vaccine

Additional relevant MeSH terms:
Meningitis
Meningitis, Meningococcal
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
 Central Nervous System Bacterial Infections
Bacterial Infections
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on May 19, 2013