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

Phase 2

Completed

• Conditions: Meningococcal Disease
• Interventions: Biological: Blood test; Biological: MenACWY-CRM197

• Registration Number: NCT00601731
• Lead Sponsor: Novartis Vaccines

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-01-15
• Study First Submitted QC: 2008-01-25
• Study First Posted: 2008-01-28
• Study Start: 2008-02
• Primary Completion: 2010-07
• Study Completion: 2010-09
• Disposition First Submitted: 2011-07-20
• Disposition First Submitted QC: 2011-07-20
• Disposition First Posted: 2011-07-25
• Results First Submitted: 2011-10-28
• Results First Submitted QC: 2012-09-17
• Results First Posted: 2012-09-19
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-14
• Last Update Posted: 2014-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 382

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-adjuvanted MenACWY vaccine group	Blood test	Blood test
Adjuvanted MenACWY vaccine group	MenACWY-CRM197	Blood test

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With hSBA ≥1:8	At 40 and 60 months of age	Percentages of subjects with human Serum Bactericidal Assay (hSBA) ≥1:8 as measured by serum bactericidal activity at 40 months and 60 months of age and associated 95% Clopper-Pearson CIs were computed for each of the serogroups within each of the vaccinated groups and in age-matched control subjects.

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects With hSBA ≥1:4	At 40 and 60 months of age	Percentages of subjects with hSBA ≥1:4 as measured by serum bactericidal activity at 40 months and 60 months of age and associated 95% Clopper-Pearson CIs were computed for each of the serogroups within each of the vaccinated groups and in age-matched control subjects.
GMTs in Subjects Within Each Site and in Age-Matched Control Subjects	At 40 and 60 months of age	The Geometric Mean Titers (GMTs) as measured by serum bactericidal activity at 40 months and 60 months of age and 95% CIs were calculated for each vaccine group and for each serogroup by exponentiating (base 10) the least square means of the logarithmically transformed (base 10) titers and their 95% CIs obtained from a two-way Analysis of Variance (ANOVA) with factors for vaccine group and center.

Trial Locations

Locations (3)

Clinical Trials Research Center; 🇨🇦 Halifax, Canada

Vaccine Evaluation Center; 🇨🇦 Vancouver, Canada

Oxford Vaccine Group; 🇬🇧 Oxford, United Kingdom