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

November 30, 2016 updated by: Novartis Vaccines

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

203

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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.
Placebo Comparator: Arm 3: Placebo
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 month after completion of immunization schedule

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 months after completion of immunization schedule

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Vaccines

Investigators

  • Study Chair: Novartis Vaccines - Drug Information Services, Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

February 27, 2006

First Submitted That Met QC Criteria

February 27, 2006

First Posted (Estimate)

March 1, 2006

Study Record Updates

Last Update Posted (Estimate)

December 1, 2016

Last Update Submitted That Met QC Criteria

November 30, 2016

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V72P3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe