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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00297817
First received: February 27, 2006
Last updated: January 3, 2012
Last verified: January 2012
  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
Meningococcal Disease
Biological: serogroup B meningococcal vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Phase 2, Single-Blind, Controlled, Randomized Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine ± OMV When Administered at an 0-2-6-Month Schedule in Healthy Adolescents 11-18 Years of Age

Resource links provided by NLM:


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 [ Time Frame: 1 month after completion of immunization schedule ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety, tolerability and immunogenicity as measured by serum bactericidal activity of the two vaccines in healthy adolescents [ Time Frame: 6 months after completion of immunization schedule ] [ Designated as safety issue: Yes ]

Enrollment: 203
Study Start Date: February 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: rMenB Biological: serogroup B meningococcal vaccine
0.5mL doses in pre-filled syringes. All subjects will receive the study vaccine following a 0,2,6 vaccination schedule.
Experimental: Arm 2: rMenB + OMV Biological: serogroup B meningococcal vaccine
0.5mL doses in pre-filled syringes. All subjects will receive the study vaccine following a 0,2,6 vaccination schedule.
Placebo Comparator: Arm 3: Placebo Biological: serogroup B meningococcal vaccine
0.5mL doses in pre-filled syringes. All subjects will receive the placebo following a 0,2,6 vaccination schedule.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Vaccines
Investigators
Study Chair: Novartis Vaccines - Drug Information Services Novartis
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00297817     History of Changes
Other Study ID Numbers: V72P3
Study First Received: February 27, 2006
Last Updated: January 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Meningococcal Disease; Meningococcal Meningitis; Vaccine

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on October 19, 2014