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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 9, 2007

Last Updated Date

August 28, 2007

Start Date ^†

February 2007

Current 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

Original 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

Change History

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

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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

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 ^†

Interventional

Study Design ^†

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

Condition ^†

Meningococcal Disease

Intervention ^†

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 ^†

Active, not recruiting

Enrollment ^†

Completion Date

February 2008

Primary Completion Date

Eligibility 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

Gender

Both

Ages

6 Months to 8 Months

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United Kingdom

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00433914

Responsible Party

Secondary IDs ^††

Eudract Number: 2006-005589-38

Study Sponsor ^†

Novartis

Collaborators ^††

Novartis Vaccines

Investigators ^†

Study Chair:

Novartis Vaccines (formerly Chiron Vaccines) Novartis

Novartis Vaccines

Information Provided By

Novartis

Verification Date

August 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.