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

This study has been completed.

Sponsors and Collaborators:	Novartis Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00310817

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 II

MedlinePlus related topics: Meningitis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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.

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

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

Keywords provided by Novartis:

meninigitis
children
vaccine

Study placed in the following topic categories:

Bacterial Infections
Central Nervous System Infections
Meningococcal Infections
Meningitis, Bacterial
Meningitis, Meningococcal
Central Nervous System Diseases

Healthy
Meningococcal infection
Gram-Negative Bacterial Infections
Neisseriaceae Infections
Meningitis

Additional relevant MeSH terms:

Nervous System Diseases
Central Nervous System Bacterial Infections

ClinicalTrials.gov processed this record on January 15, 2009