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

Primary Purpose

Meningococcal Disease

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

serogroup B meningococcal vaccine

About this trial

This is an interventional prevention trial for Meningococcal Disease focused on measuring Meningococcal Disease; Meningococcal Meningitis; Vaccine

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1: rMenB

Arm 2: rMenB + OMV

Arm 3: Placebo

Arm Description

Outcomes

Primary Outcome Measures

Safety, tolerability and immunogenicity as measured by serum bactericidal activity of the two vaccines in healthy adolescents

Secondary Outcome Measures

Safety, tolerability and immunogenicity as measured by serum bactericidal activity of the two vaccines in healthy adolescents

Full Information

NCT ID

NCT00297817

First Posted

February 27, 2006

Last Updated

November 30, 2016

Sponsor

Novartis Vaccines

1. Study Identification

Unique Protocol Identification Number

NCT00297817

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Completed

Study Start Date

February 2006 (undefined)

Primary Completion Date

April 2007 (Actual)

Study Completion Date

April 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Vaccines

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Meningococcal Disease

Keywords

Meningococcal Disease; Meningococcal Meningitis; Vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

203 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1: rMenB

Arm Type

Experimental

Arm Title

Arm 2: rMenB + OMV

Arm Type

Experimental

Arm Title

Arm 3: Placebo

Arm Type

Placebo Comparator

Intervention Type

Biological

Intervention Name(s)

serogroup B meningococcal vaccine

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

serogroup B meningococcal vaccine

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

serogroup B meningococcal vaccine

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

11 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Vaccines - Drug Information Services

Organizational Affiliation

Novartis

Official's Role

Study Chair

Facility Information:

City

Encinitas

State/Province

California

ZIP/Postal Code

92024

Country

United States

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44118

Country

United States

City

Galveston

State/Province

Texas

ZIP/Postal Code

77555

Country

United States

City

Layton

State/Province

Utah

ZIP/Postal Code

84123

Country

United States

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84121

Country

United States

City

Seattle

State/Province

Washington

ZIP/Postal Code

98101

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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