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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00297817

Enrollment

203

Registered

2006-03-01

Start date

2006-02-28

Completion date

2007-04-30

Last updated

2016-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meningococcal Disease

Keywords

Meningococcal Disease; Meningococcal Meningitis; Vaccine

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.

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

11 Years to 18 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Safety, tolerability and immunogenicity as measured by serum bactericidal activity of the two vaccines in healthy adolescents	1 month after completion of immunization schedule

Secondary

Measure	Time frame
Safety, tolerability and immunogenicity as measured by serum bactericidal activity of the two vaccines in healthy adolescents	6 months after completion of immunization schedule

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026