MedTrace Logo

Safety and Immunogenicity of Meningococcal ACWY Conjugate Versus Polysaccharide Vaccine in Children 2 to 10 Years of Age

NCT00329849 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1500

Last updated 2018-10-09

Study results available
· View outcomes & findings →

Summary

Safety and immunogenicity of meningococcal ACWY conjugate versus polysaccharide vaccine in children 2 to 10 years of age

Conditions

  • Meningococcal Disease

Interventions

BIOLOGICAL

Meningococcal ACWY-CRM conjugate vaccine

MenACWY-CRM vaccine was obtained by extemporaneous mixing of the lyophilized MenA component to be resuspended with the liquid MenCWY component. One dose (0.5 mL) was administered by IM injection in the deltoid area of the arm without a BCG scar.

BIOLOGICAL

Meningococcal ACWY-PS polysaccharide vaccine

MenACWY-PS vaccine was supplied as a single dose (one vial of vaccine and one vial of diluent). One dose (0.5 mL) of MenACWY-PS vaccine was administered by SC injection in the deltoid area of the arm without a BCG scar.

Sponsors & Collaborators

  • Novartis Vaccines

    lead INDUSTRY

Principal Investigators

  • Novartis Vaccines & Diagnostics · Novartis Vaccines & Diagnostics

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2007-03-31
Completion
2007-03-31

Countries

  • Argentina

Study Locations

More Related Trials

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 NCT00329849 on ClinicalTrials.gov