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A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults

NCT00450437 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3539

Last updated 2015-01-28

Study results available
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Summary

This study will evaluate the lot to lot consistency, safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine in healthy US adolescents and adults.

Conditions

  • Meningococcal Infections
  • Meningococcal Meningitis

Interventions

BIOLOGICAL

MenACWY CRM

One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.

BIOLOGICAL

Meningococcal ACWY Conjugate vaccine

One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.

Sponsors & Collaborators

  • Novartis Vaccines

    lead INDUSTRY

Principal Investigators

  • Novartis Vaccines and Diagnostics · Novartis

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2007-08-31
Completion
2008-01-31

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 NCT00450437 on ClinicalTrials.gov