Study of the Safety and Immune Response of Two Serogroup B Meningococcal Vaccines Administered to Healthy Adolescents
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
1 other identifier
interventional
203
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2006
Shorter than P25 for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 27, 2006
CompletedFirst Posted
Study publicly available on registry
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedDecember 1, 2016
January 1, 2012
1.2 years
February 27, 2006
November 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Safety, tolerability and immunogenicity as measured by serum bactericidal activity of the two vaccines in healthy adolescents
6 months after completion of immunization schedule
Study Arms (3)
Arm 1: rMenB
EXPERIMENTALArm 2: rMenB + OMV
EXPERIMENTALArm 3: Placebo
PLACEBO COMPARATORInterventions
0.5mL doses in pre-filled syringes. All subjects will receive the study vaccine following a 0,2,6 vaccination schedule.
Eligibility Criteria
You may qualify if:
- Healthy Adolescents between and including 11-18 years of age, who provide written informed consent.
You may not qualify if:
- Previous or suspected disease caused by N. meningitidis; or previous immunization with a serogroup B meningococcal vaccine; Any acute, chronic or progressive disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Unknown Facility
Encinitas, California, 92024, United States
Unknown Facility
Atlanta, Georgia, 30322, United States
Unknown Facility
St Louis, Missouri, 63110, United States
Unknown Facility
Cleveland, Ohio, 44118, United States
Unknown Facility
Galveston, Texas, 77555, United States
Unknown Facility
Layton, Utah, 84123, United States
Unknown Facility
Salt Lake City, Utah, 84121, United States
Unknown Facility
Seattle, Washington, 98101, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Novartis Vaccines - Drug Information Services
Novartis
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2006
First Posted
March 1, 2006
Study Start
February 1, 2006
Primary Completion
April 1, 2007
Study Completion
April 1, 2007
Last Updated
December 1, 2016
Record last verified: 2012-01