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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2007-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Meningococcal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Arm 1: rMenB

Group Type EXPERIMENTAL

serogroup B meningococcal vaccine

Intervention Type BIOLOGICAL

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

Arm 2: rMenB + OMV

Group Type EXPERIMENTAL

serogroup B meningococcal vaccine

Intervention Type BIOLOGICAL

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

Arm 3: Placebo

Group Type PLACEBO_COMPARATOR

serogroup B meningococcal vaccine

Intervention Type BIOLOGICAL

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

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

11 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes