Safety, Tolerability and Immunogenicity of Two Different Formulations of MenB Vaccine, When Administered to Healthy Infants

This study has been completed.

First Received: February 9, 2007 Last Updated: October 22, 2009 History of Changes

Sponsor:	Novartis
Collaborator:	Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00433914

Purpose

This study is aimed to explore safety and immunogenicity of two formulations of a Meningococcal B Vaccine when administered to healthy infants.

Condition	Intervention	Phase
Meningococcal Disease	Biological: Serogroup B meningococcal Vaccine	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 2, Single Blind, Single Center, Randomized Study of the Safety, Tolerability and Immunogenicity of Two Different Formulations of Novartis Meningococcal B Vaccine, When Administered to Healthy Infants

Resource links provided by NLM:

Drug Information available for: Meningococcal Vaccines

Further study details as provided by Novartis:

Primary Outcome Measures:

Immunogenicity as measured by serum bactericidal activity of the two vaccines at one month after completion of immunization schedule
Safety and tolerability of the two vaccines throughout the clinical study

Secondary Outcome Measures:

Immunogenicity as measured by serum bactericidal activity of the two vaccines at one month after 2 vaccine administration

Estimated Enrollment:	60
Study Start Date:	February 2007
Estimated Study Completion Date:	June 2008

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

previous receipt of any meningococcal B vaccine;
previous ascertained or suspected disease caused by N. meningitidis
history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
any present or suspected serious acute or chronic disease
known or suspected autoimmune disease or impairment /alteration of immune function

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00433914

Locations

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators

Study Chair:

Novartis Vaccines (formerly Chiron Vaccines) Novartis

Novartis Vaccines

More Information

No publications provided

Study ID Numbers:	V72P9, Eudract Number: 2006-005589-38
Study First Received:	February 9, 2007
Last Updated:	October 22, 2009
ClinicalTrials.gov Identifier:	NCT00433914 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:

Meningococcal disease, prevention, vaccination

Additional relevant MeSH terms:

Bacterial Infections
Meningococcal Infections
Gram-Negative Bacterial Infections
Neisseriaceae Infections

ClinicalTrials.gov processed this record on November 30, 2009