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CompletedNCT00297817Updated Dec 1, 2016

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

A Phase 2 interventional study of serogroup B meningococcal vaccine and serogroup B meningococcal vaccine in Meningococcal Disease, sponsored by Novartis Vaccines. Completed at 8 sites in United States. Open to participants aged 11 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-01.

Sponsored by Novartis Vaccines · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
203
Allocation
Randomized
Ages
11 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Meningococcal Disease

Keywords

  • Meningococcal Disease; Meningococcal Meningitis; Vaccine
03

In context

Meningococcal Infections

219 studies on the registry are indexed under Meningococcal Infections; 6 are open to participants now.

This study's enrollment of 203 is below the median of 450 across 190 interventional studies indexed under Meningococcal Infections.

Browse Meningococcal Infections studies →

Lead sponsor

Novartis Vaccines is the lead sponsor of 161 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
203 participants (actual)

Study arms

  • Experimental
    Arm 1: rMenB

    Biological: serogroup B meningococcal vaccine

  • Experimental
    Arm 2: rMenB + OMV

    Biological: serogroup B meningococcal vaccine

  • Placebo comparator
    Arm 3: Placebo

    Biological: serogroup B meningococcal vaccine

Interventions

  • Biologicalserogroup B meningococcal vaccine

    0.5mL doses in pre-filled syringes. All subjects will receive the study vaccine following a 0,2,6 vaccination schedule.

  • Biologicalserogroup B meningococcal vaccine

    0.5mL doses in pre-filled syringes. All subjects will receive the study vaccine following a 0,2,6 vaccination schedule.

  • Biologicalserogroup B meningococcal vaccine

    0.5mL doses in pre-filled syringes. All subjects will receive the placebo following a 0,2,6 vaccination schedule.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

07

Study locations

8 sites
  • Encinitas, California 92024, United States
  • Atlanta, Georgia 30322, United States
  • St. Louis, Missouri 63110, United States
  • Cleveland, Ohio 44118, United States
  • Galveston, Texas 77555, United States
  • Layton, Utah 84123, United States
  • Salt Lake City, Utah 84121, United States
  • Seattle, Washington 98101, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00297817
Lead sponsor
Novartis Vaccines
Responsible party
Sponsor
First posted
Mar 1, 2006
Start date
Feb 2006
Primary completion
Apr 2007
Completion
Apr 2007
Last update
Dec 1, 2016

Study contacts

Novartis Vaccines - Drug Information Services
study chair · Novartis

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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