Persistence of Antibody Response to N. Meningitidis Group C in Children - Full Text View

Sponsors and Collaborators:	Novartis Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00316654

Purpose

Persistence of Antibody Response to N. meningitidis Group C in Children

Condition	Intervention	Phase
Prevention of Meningococcal Infection	Biological: Meningococcal C conjugate vaccine	Phase IV

MedlinePlus related topics: Childhood Immunization

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase IV, Multi-Center, Open-Label, Unrandomized Study to Evaluate the Persistence of Antibody Response to N. Meningitidis Group C, Before and After 2 Doses of the Conjugate Pneumococcal Vaccine, in Children Seven Months and Older Who Previously Received Immunization With Chiron Meningococcal C Conjugate Vaccine and a Hexavalent Infant Vaccine According to the Applicable Infant Immunization Schedule

Further study details as provided by Novartis:

Primary Outcome Measures:

Immunogenicity: serum antibody responses, as measured by bactericidal activity,using hBCA

Secondary Outcome Measures:

Evaluate and compare persistence of antibody response to N. meningitidis serogroup C as measured by serum bactericidal activity
safety and tolerability

Estimated Enrollment:	573
Study Start Date:	February 2005

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00316654

Locations

Poland

Olsztyn, Lubartów, Kielce, Kraków, Bydgoszcz, Poland
Spain

Valencia, Spain

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators

Principal Investigator:

Novartis Vaccines - Drug Information Services

Novartis Vaccines & Diagnostics

More Information

Study ID Numbers:	V14P38E1, Impact N° 1396
Study First Received:	April 19, 2006
Last Updated:	September 13, 2006
ClinicalTrials.gov Identifier:	NCT00316654
Health Authority:	Spain: Spanish Agency of Medicines; Poland: Ministry of Health

Keywords provided by Novartis:

Prevention of Meningococcal Meningitis
vaccines, conjugate
immunology
child
antibody persistence

Study placed in the following topic categories:

Bacterial Infections
Antibodies
Meningococcal Infections
Meningitis, Meningococcal
Neisseria meningitidis

Immunoglobulins
Meningococcal infection
Gram-Negative Bacterial Infections
Neisseriaceae Infections
Meningitis

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009