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Lot Consistency, Immuno, Safety of Meningococcal Vaccine GSK134612 Given With Fluarix™ to 18-55 Year-Old Adults

NCT00453986 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1352

Last updated 2018-09-25

Study results available
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Summary

The purpose of this study is to demonstrate, in 18-55 year old adults, the consistency of different manufactured lots of meningococcal vaccine GSK134612, the non-inferiority of GSK134612 compared to licensed meningococcal vaccine Mencevax™, the non-inferiority of GSK134612 when given in an experimental co-administration with Fluarix™ compared to GSK134612 given alone and the immunogenicity of GSK134612 given with Fluarix™.

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

One intramuscular dose

BIOLOGICAL

Mencevax™ACWY

One subcutaneous dose

BIOLOGICAL

Fluarix™

One intramuscular dose

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-04-09
Primary Completion
2007-11-30
Completion
2008-05-21

Countries

  • Lebanon
  • Philippines

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 NCT00453986 on ClinicalTrials.gov