Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in Healthy Children

This study is ongoing, but not recruiting participants.

First Received: April 3, 2006 Last Updated: April 23, 2008 History of Changes

Sponsors and Collaborators:	Novartis Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00311415

Purpose

Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in healthy children

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

MedlinePlus related topics: Memory

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Phase III, Multi-Center, Open-Label, Controlled, Randomized Study to Evaluate the Immunogenicity, Safety, Tolerability and the Ability to Prime for Memory of Chiron Meningococcal C Conjugate Vaccine When Administered to Healthy Infants as One Dose Given at 2 or 6 Months of Age With a Booster at 12-16 Months of Age, in Comparison to Two Doses in the First Year of Life, Given Two Months Apart, With a Booster at 12-16 Months of Age; and in Comparison to One Dose Given at 12-16 Months of Age

Further study details as provided by Novartis:

Primary Outcome Measures:

demonstration of non-inferiority of memory antibody response after 1 dose of MenC Vaccine administered to healthy infants at 2 to 6 months of age and as first, second or third dose in the second year of life,as measured by rBCA.

Secondary Outcome Measures:

Evaluation and comparison of antibody response in terms of GMT and percent responders, as measured by rBCA.

Estimated Enrollment:	252
Study Start Date:	October 2005

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

known hypersensitivity to any vaccine component
significant acute or chronic infections
previously ascertained or suspected disease caused by N. meningitidis
previous household contact with an individual with a positive culture of N. meningitidis serogroup C

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311415

Locations

Germany

Mainz, Kehl, Neumünster, Ettenheim, Germany
Poland

Kraków, Lubartów, Lublin, Bydgosczcz, Poland

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators

Principal Investigator:

Novartis Vaccines - Information Services

Novartis Vaccines & Diagnostics

More Information

No publications provided

Study ID Numbers:	M14P6, Impact N° 919
Study First Received:	April 3, 2006
Last Updated:	April 23, 2008
ClinicalTrials.gov Identifier:	NCT00311415 History of Changes
Health Authority:	Germany: Paul-Ehrlich-Institut; Poland: Office for Registration of Medicinal Products Medical Devices and Biocides

Keywords provided by Novartis:

Prevention of Meningococcal Meningitis
meningococcal vaccines
conjugate

immunology
infant
antibody persistence

Study placed in the following topic categories:

Bacterial Infections
Antibodies
Meningococcal Infections
Meningitis, Meningococcal
Meningococcal Infection

Healthy
Immunoglobulins
Gram-Negative Bacterial Infections
Neisseriaceae Infections
Meningitis

Additional relevant MeSH terms:

Bacterial Infections
Meningococcal Infections
Infection
Gram-Negative Bacterial Infections
Neisseriaceae Infections

ClinicalTrials.gov processed this record on May 07, 2009