Safety, Tolerability and Immunogenicity of Three Doses of Novartis Meningococcal B Vaccine When Administered to Healthy at-Risk Adults - Full Text View

Purpose

This study is aimed to evaluate safety, tolerabilty and immunogenicity of three doses of Novartis Meningococcal B vaccine and of one dose of Novartis Menongococcal ACWY vaccine when adnministered to healthy at-risk adults

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

ChemIDplus related topics:

Meningococcal Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Phase 2, Multi-Center, Open-Label Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Vaccine When Administered at a 0, 2, 6-Month Schedule and of a Single Dose of Novartis Meningococcal ACWY Vaccine in Healthy At-Risk Adults 18-50 Years of Age

Further study details as provided by Novartis:

Primary Outcome Measures:

Immunogenicity as measured by serum bactericidal activity of the Meningococcal B vaccine at one month after completion of immunization schedule [ Time Frame: one month ]
Safety and tolerability of the two Meningococcal vaccines throughout the clinical study [ Time Frame: one month ]

Secondary Outcome Measures:

Immunogenicity as measured by serum bactericidal activity of the Meningococcal B vaccine at one month after the first and the second immunization [ Time Frame: one month ]
Immunogenicity as measured by serum bactericidal activity of the Meningococcal ACWY vaccine at one month after the immunization [ Time Frame: one month ]

Estimated Enrollment:	250
Study Start Date:	July 2007
Estimated Study Completion Date:	April 2009

Arms	Assigned Interventions
1	Biological: serogroups ACWY meningococcal vaccine a single dose of a 0.5 mL injectable solution Biological: Serogroup B meningococcal Vaccine All subjects will receive the study vaccine following a 0,2,6 vaccination schedule. Pre-filled syringe, administered by intramuscular injection into the deltoid area of the non dominant arm.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

healthy adults,18 through 50 years of age, who are or may be routinely exposed to N. meningitidis cultures

Exclusion Criteria:

previous ascertained or suspected disease caused by N. meningitidis;
pregnancy or breastfeeding;
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: NCT00560313

Contacts


Contact: Novartis Drug information services	+1 800 244 7668

Locations


Italy
	Azienda USL 7 of Siena	Recruiting
	Siena, Italy, 53100
	Contact 0039 0577 51293
	Principal Investigator: Novartis Vaccines

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators


Study Chair:	Novartis Vaccines	Novartis Vaccines

More Information

Study ID Numbers:	V72P4, 2007-001563-29
First Received:	November 16, 2007
Last Updated:	November 16, 2007
ClinicalTrials.gov Identifier:	NCT00560313
Health Authority:	Germany: Paul-Ehrlich-Institute

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 October 15, 2008

Sponsors and Collaborators:	Novartis Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00560313