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Co-Administration of Meningococcal Vaccine GSK134612 With Infanrix Hexa™ Versus Individual Administration of Each Vaccine

NCT00508261 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 793

Last updated 2019-01-24

Study results available
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Summary

The purpose of this study is to demonstrate, in 12-23 months old subjects, the non-inferiority of meningococcal vaccine GSK134612 co-administered with Infanrix hexa™, compared to each vaccine administered individually and to licensed meningococcal vaccine Meningitec™.

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

Conditions

  • Infections, Meningococcal

Interventions

BIOLOGICAL

Meningococcal vaccine GSK134612

Single dose intramuscular injection

BIOLOGICAL

Infanrix™ hexa

Single dose intramuscular injection

BIOLOGICAL

Meningitec™

Single dose intramuscular injection

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
23 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-08-01
Primary Completion
2008-05-26
Completion
2008-10-27

Countries

  • Austria
  • Germany
  • Greece

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 NCT00508261 on ClinicalTrials.gov