Safety, Tolerability and Immunogenicity of Meningococcal C Conjugate Vaccine to Children 32 to 40 Months of Age

This study has been completed.

First Received: April 3, 2006 Last Updated: October 25, 2006 History of Changes

Sponsor:	Novartis
Collaborator:	Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00310635

Purpose

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

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Phase IV, Multi-Center, Controlled Open-Label Study to Evaluate the Safety, Tolerability and Immunogenicity of a Commercially Available Meningococcal C Vaccine When Given as First, Third or Fourth Immunization to Children 32-40 Months of Age

Further study details as provided by Novartis:

Primary Outcome Measures:

Determination of memory antibody response to Neisseria meningitidis serogroup C after 2 or 3 doses of MenC vaccine given during infancy, as measured by hBCA at day 0 and day 28.

Secondary Outcome Measures:

Determination of antibody titers in naïve control subjects.
Determination of persistence of antibody response after either 2 or 3 doses of MenC vaccine given during infancy and one dose of MenPS A/C vaccine given at 12 months of age.
Evaluation of the safety and tolerability of a single 0.5 mL intramuscular (IM) injection of MenC Vaccine when given to children approximately three years of age.

Estimated Enrollment:	241
Study Start Date:	June 2005

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

known hypersensitivity to any vaccine component
significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past 14 days
ascertained or suspected disease caused by N. meningitidis
household contact with or intimate exposure to an individual with a positive culture of N. meningitidis serogroup C within the previous 60 days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00310635

Locations

Germany, Kempten
Mainz, Kehl, Traunreut, Mühldorf am Inn, Bad Sobernheim, Bad Kreuznach, Baldham, Speyer,
Oppenheim,, Kempten, Germany

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators

Principal Investigator:

Vaccines - Information Services

Novartis Vaccines & Diagnostics

More Information

No publications provided

Study ID Numbers:	M14P1E1, Impact N° 1453
Study First Received:	April 3, 2006
Last Updated:	October 25, 2006
ClinicalTrials.gov Identifier:	NCT00310635 History of Changes
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by Novartis:

Prevention of meningococcal infection

Additional relevant MeSH terms:

Bacterial Infections
Communicable Diseases
Meningococcal Infections

Infection
Gram-Negative Bacterial Infections
Neisseriaceae Infections

ClinicalTrials.gov processed this record on November 27, 2009