A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults - Full Text View

Sponsors and Collaborators:	Novartis Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00450437

Purpose

This study will evaluate the lot to lot consistency, safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine in healthy US adolescents and adults.

Condition	Intervention	Phase
Meningococcal Disease Meningococcal Meningitis	Biological: Novartis Meningococcal ACWY Conjugate Vaccine	Phase III

MedlinePlus related topics: Meningitis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 3, Multi-Center Study to Evaluate Lot to Lot Consistency, Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults and Compare to the Safety and Immune Response to a Licensed Conjugate Meningococcal ACWY Vaccine

Further study details as provided by Novartis:

Primary Outcome Measures:

Immunogenicity of Novartis MenACWY compared with immunogenicity of a single dose of licensed meningococcal ACWY conjugate vaccine defined as measured by serum bactericidal activity one month after vaccination.
Safety of Novartis MenACWY compared with that of licensed meningococcal ACWY conjugate vaccine as measured by the percentage of subjects presenting at least one severe systemic reaction during the first 7 days (Day 1-7) following a single dose.
To assess the consistency of 3 manufactured lots as measured by geometric mean titers of serum bactericidal antibodies measured one month after vaccination.

Secondary Outcome Measures:

Safety and tolerability

Estimated Enrollment:	3000
Study Start Date:	March 2007

Eligibility

Ages Eligible for Study:	11 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Healthy subjects who are 11-55 years of age inclusive and who have given appropriate written assent and/or consent

Exclusion Criteria:

Subjects with a previous or suspected disease caused by N. meningitidis
previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
previous or suspected disease caused by N. meningitidis
Any serious acute, chronic or progressive disease
Pregnant or breastfeeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00450437

Locations

United States, Alabama

Birmingham, Alabama, United States, 35205

Birmingham, Alabama, United States, 35244

Tuscaloosa, Alabama, United States, 35487-0326
United States, California

Oakland, California, United States, 94612

Sacramento, California, United States, 95817
United States, Colorado

Denver, Colorado, United States, 80218
United States, Georgia

Marietta, Georgia, United States, 30062

Woodstock, Georgia, United States, 30189

Atlanta, Georgia, United States, 30322
United States, Illinois

Chicago, Illinois, United States, 60614-3394
United States, Maryland

Frederick, Maryland, United States, 21702

Annapolis, Maryland, United States, 21401
United States, Massachusetts

Boston, Massachusetts, United States, 02118

Fall River, Massachusetts, United States, 02124
United States, New Hampshire

Lebanon, New Hampshire, United States, 03756
United States, Ohio

Akron, Ohio, United States, 44308

Cleveland, Ohio, United States, 44118

Cincinnati, Ohio, United States, 45229
United States, Pennsylvania

Pittsburgh, Pennsylvania, United States, 15241

Sellersville, Pennsylvania, United States, 18960

Harleyville, Pennsylvania, United States, 19438
United States, Texas

Galveston, Texas, United States, 77555-0371
United States, Washington

Seattle, Washington, United States, 98101-1466

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators

Study Chair:

Novartis Vaccines - Information Services

Novartis

More Information

Study ID Numbers:	V59P13
Study First Received:	March 21, 2007
Last Updated:	April 16, 2008
ClinicalTrials.gov Identifier:	NCT00450437
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Meningococcal
meningitis
vaccine
adolescents
adults

Study placed in the following topic categories:

Bacterial Infections
Central Nervous System Infections
Meningococcal Infections
Meningitis, Bacterial
Meningitis, Meningococcal

Central Nervous System Diseases
Meningococcal infection
Gram-Negative Bacterial Infections
Neisseriaceae Infections
Meningitis

Additional relevant MeSH terms:

Nervous System Diseases
Central Nervous System Bacterial Infections

ClinicalTrials.gov processed this record on January 14, 2009