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

Tracking Information

First Received Date ^ICMJE

February 9, 2007

Last Updated Date

October 22, 2009

Start Date ^ICMJE

February 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00433914 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Single Blind, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Meningococcal Disease

Intervention ^ICMJE

Biological: Serogroup B meningococcal Vaccine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

June 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Months to 8 Months

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00433914

Responsible Party

Study ID Numbers ^ICMJE

V72P9, Eudract Number: 2006-005589-38

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Novartis Vaccines

Investigators ^ICMJE

Study Chair:

Novartis Vaccines (formerly Chiron Vaccines) Novartis

Novartis Vaccines

Information Provided By

Novartis

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP