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

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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	Novartis 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

ChemIDplus related topics:

Meningococcal Vaccines

U.S. FDA Resources

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

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:	February 2008

Eligibility

Ages Eligible for Study:	6 Months to 8 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

healthy 6-8 months old infants

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


United Kingdom

	Oxford, United Kingdom, OX3 7LJ

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators


Study Chair:	Novartis Vaccines (formerly Chiron Vaccines) Novartis	Novartis Vaccines

More Information

Study ID Numbers:	V72P9, Eudract Number: 2006-005589-38
First Received:	February 9, 2007
Last Updated:	August 28, 2007
ClinicalTrials.gov Identifier:	NCT00433914
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:

Meningococcal disease, prevention, vaccination

Study placed in the following topic categories:

Bacterial Infections

Meningococcal Infections

Healthy

Meningococcal infection

Gram-Negative Bacterial Infections

Neisseriaceae Infections

ClinicalTrials.gov processed this record on September 05, 2008