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

Novartis

Status and phase: Completed; Phase 2

Conditions: Meningococcal Disease

Treatments: Biological: serogroup B meningococcal vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00297817

V72P3

Details and patient eligibility

About

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.

Enrollment: 203 patients

Sex: All

Ages: 11 to 18 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

203 participants in 3 patient groups, including a placebo group

Arm 1: rMenB

Experimental group

Treatment:

Biological: serogroup B meningococcal vaccine

Biological: serogroup B meningococcal vaccine

Biological: serogroup B meningococcal vaccine

Arm 2: rMenB + OMV

Experimental group

Treatment:

Biological: serogroup B meningococcal vaccine

Biological: serogroup B meningococcal vaccine

Biological: serogroup B meningococcal vaccine

Arm 3: Placebo

Placebo Comparator group

Treatment:

Biological: serogroup B meningococcal vaccine

Biological: serogroup B meningococcal vaccine

Biological: serogroup B meningococcal vaccine