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

Novartis Vaccines203 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

203

Conditions

Meningococcal Disease

Interventions

serogroup B meningococcal vaccineBIOLOGICAL

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

serogroup B meningococcal vaccineBIOLOGICAL

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

serogroup B meningococcal vaccineBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 11 YearsMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (8)

Unnamed facility

Encinitas, California, United States

Unnamed facility

Atlanta, Georgia, United States

Unnamed facility

St Louis, Missouri, United States

Unnamed facility

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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