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

NCT00297817 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 203

Last updated 2016-12-01

No results posted yet for this study

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.

Conditions

  • Meningococcal Disease

Interventions

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.

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.

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.

Sponsors & Collaborators

  • Novartis Vaccines

    lead INDUSTRY

Principal Investigators

  • Novartis Vaccines - Drug Information Services · Novartis

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2007-04-30
Completion
2007-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00297817 on ClinicalTrials.gov