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Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 2-10 Year Old Subjects

NCT00514904 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1504

Last updated 2020-10-27

Study results available
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Summary

The purpose of this study is to demonstrate, in 2-10 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

  • Infections, Meningococcal
  • Meningococcal Vaccines

Interventions

BIOLOGICAL

Nimenrix

Single dose, intramuscular injection

BIOLOGICAL

Mencevax

Single dose, subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-09-18
Primary Completion
2008-09-03
Completion
2009-01-06

Countries

  • India
  • Lebanon
  • Philippines
  • Saudi Arabia

Study Locations

More Related Trials

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 NCT00514904 on ClinicalTrials.gov