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Study of the Safety and Immune Response of a Meningococcal Conjugate Vaccine Administered to Healthy Adolescents

NCT00262041 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 524

Last updated 2018-06-28

Study results available
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Summary

The purpose of this study is to evaluate the safety and immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in comparison to licensed meningococcal polysaccharide vaccine administered to healthy adolescents ages 11 to 17 years.

Conditions

  • Prevention of Meningococcal Disease

Interventions

BIOLOGICAL

MenACWY-CRM conjugate vaccine, adjuvanted

BIOLOGICAL

MenACWY-CRM conjugate vaccine, unadjuvanted

BIOLOGICAL

MenACWY polysaccharide vaccine

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Novartis Vaccines

    lead INDUSTRY

Principal Investigators

  • Novartis Vaccines · Novartis

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2006-03-31
Completion
2006-03-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00262041 on ClinicalTrials.gov