Evaluation of Meningococcal ACWY Immune Response in Children Aged 40 and 60 Months

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

PHASE2

Total Enrollment

382 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-09-30

Brief Summary

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The purpose of this study is to evaluate how well the immuno response against meningococcal serogroups A, C, W and Y lasts in children who were vaccinated with MenACWY as infants.

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Detailed Description

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Conditions

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Meningococcal Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Adjuvanted MenACWY vaccine group

Blood test

Group Type EXPERIMENTAL

MenACWY-CRM197

Intervention Type BIOLOGICAL

Blood test, 40-months and 60-months children

Non-adjuvanted MenACWY vaccine group

Blood test

Group Type ACTIVE_COMPARATOR

Blood test

Intervention Type BIOLOGICAL

Blood test, 40-months and 60-months children

Interventions

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MenACWY-CRM197

Blood test, 40-months and 60-months children

Intervention Type BIOLOGICAL

Blood test

Blood test, 40-months and 60-months children

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Follow-on, healthy 40, 60 months old participants who have completed the V59P5 study and are in good health
* Control subjects: healthy 60 months old who had received a complete MenC immunization course