Study of the Safety and Immune Response of Two Serogroup B Meningococcal Vaccines Administered to Healthy Adolescents

This study has been completed.

Sponsors and Collaborators:	Novartis Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00297817

Purpose

The purpose of this study is to evaluate the safety and immunogenicity of two serogroup B meningococcal vaccines in comparison to placebo administered to healthy adolescents ages 11 to 18 years.

Condition	Intervention	Phase
Prevention of Meningococcal Disease	Biological: serogroup B meningococcal vaccine	Phase II

MedlinePlus related topics: Childhood Immunization

Drug Information available for: Meningococcal Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Novartis:

Primary Outcome Measures:

Safety, tolerability and immunogenicity as measured by serum bactericidal activity of the two vaccines in healthy adolescents, 1 month after completion of immunization schedule.

Secondary Outcome Measures:

Safety, tolerability and immunogenicity as measured by serum bactericidal activity of the two vaccines in healthy adolescents, 6 months after completion of immunization schedule.

Estimated Enrollment:	200
Study Start Date:	February 2006

Eligibility

Ages Eligible for Study:	11 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy Adolescents between and including 11-18 years of age, who provide written informed consent.

Exclusion Criteria:

Previous or suspected disease caused by N. meningitidis; or previous immunization with a serogroup B meningococcal vaccine; Any acute, chronic or progressive disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00297817

Locations

United States, California

Encinitas, California, United States, 92024
United States, Georgia

Atlanta, Georgia, United States, 30322
United States, Missouri

St. Louis, Missouri, United States, 63110
United States, Ohio

Cleveland, Ohio, United States, 44118
United States, Texas

Galveston, Texas, United States, 77555
United States, Utah

Layton, Utah, United States, 84123

Salt Lake City, Utah, United States, 84121
United States, Washington

Seattle, Washington, United States, 98101

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators

Study Chair:

Novartis Vaccines - Drug Information Services

Novartis

More Information

Study ID Numbers:	V72P3
Study First Received:	February 27, 2006
Last Updated:	April 23, 2008
ClinicalTrials.gov Identifier:	NCT00297817
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Meningococcal Disease; Meningococcal Meningitis; Vaccine

Study placed in the following topic categories:

Bacterial Infections
Meningococcal Infections
Meningitis, Meningococcal
Healthy

Meningococcal infection
Gram-Negative Bacterial Infections
Neisseriaceae Infections
Meningitis

ClinicalTrials.gov processed this record on January 15, 2009