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Co-Administration of Meningoc...

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

Last Updated: 2019-01-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

793 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-01

Study Completion Date

2008-10-27

Brief Summary

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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.

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Detailed Description

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Multicentre study with 4 parallel groups. One group will receive GSK134612 co-administered with Infanrix hexa™, two groups will receive sequential administration of GSK134612 and Infanrix hexa™ and the final group will receive Meningitec™.

For subjects in Groups B and C, three blood samples will be taken: prior to first vaccination and 1 month after each vaccination.

For subjects in Groups A and D, two blood samples will be taken: prior to and 1 month after vaccination.

Conditions

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Infections, Meningococcal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group A

Meningococcal vaccine GSK134612 co-administered with Infanrix hexa™

Group Type EXPERIMENTAL