MedTrace Logo

A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Healthy Adults

NCT00474487 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2831

Last updated 2014-04-21

Study results available
· View outcomes & findings →

Summary

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

Conditions

  • Meningococcal Meningitis
  • Meningococcal Infections

Interventions

BIOLOGICAL

Meningococcal ACWY Polysaccharide Vaccine

One dose of the licensed meningococcal ACWY polysaccharide vaccine was administered by subcutaneous injection.

BIOLOGICAL

MenACWY CRM (19 to 55 years)

One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection to subjects 19 years to 55 years of age.

BIOLOGICAL

Meningococcal ACWY Conjugate Vaccine

One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered by intramuscular injection.

BIOLOGICAL

Novartis MenACWY Vaccine (56 to 65 Years)

One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection administered to subjects 56 years to 65 years of age.

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
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2007-08-31
Completion
2008-02-29

Countries

  • Argentina
  • Colombia

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 NCT00474487 on ClinicalTrials.gov