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Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children

NCT00616421 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2907

Last updated 2016-02-15

Study results available
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Summary

To evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given to healthy children compared to a licensed Meningococcal ACWY polysaccharide-protein conjugate vaccine.

Conditions

  • Meningococcal Infections

Interventions

BIOLOGICAL

MenACWY-CRM

1 injection of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly

BIOLOGICAL

MenACWY-CRM

2 injections of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly to children 2 to 5 years of age

BIOLOGICAL

Licensed meningococcal ACWY vaccine

1 injection of the licensed meningococcal ACWY 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
2 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-04-30
Completion
2009-10-31

Countries

  • United States
  • Canada

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 NCT00616421 on ClinicalTrials.gov