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

Novartis

Status and phase: Completed; Phase 2

Conditions: Meningococcal Disease

Treatments: Biological: Blood test; Biological: MenACWY-CRM197

Study type: Interventional

Funder types: Industry

Identifiers

NCT00601731

2007-004978-16

V59P5E1

Details and patient eligibility

About

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.

Enrollment: 382 patients

Sex: All

Ages: 40 to 63 months old

Volunteers: Accepts Healthy Volunteers

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

Exclusion criteria

• Subjects with any serious, acute or chronic progressive disease

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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382 participants in 2 patient groups

Adjuvanted MenACWY vaccine group

Experimental group

Description:

Blood test

Treatment:

Biological: MenACWY-CRM197

Non-adjuvanted MenACWY vaccine group

Active Comparator group

Description:

Blood test

Treatment:

Biological: Blood test