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

Study Overview
=================
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.

Official Title
-----------------
A Phase 2, Open-label, Controlled, Multi-center Study to Evaluate Meningococcal ACWY Antibody Response in Children Aged 40 and 60 Months Who Have Previously Received Novartis MenACWY Conjugate Vaccine as Infants

Conditions
-----------------
Meningococcal Disease

Intervention / Treatment
-----------------
* Biological: MenACWY-CRM197
* Biological: Blood test


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Months
Maximum Age: 63 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adjuvanted MenACWY vaccine group<br>Blood test | Biological: MenACWY-CRM197<br>* Blood test, 40-months and 60-months children<br>|
| Active Comparator: Non-adjuvanted MenACWY vaccine group<br>Blood test | Biological: Blood test<br>* Blood test, 40-months and 60-months children<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With hSBA ≥1:8 | 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. | At 40 and 60 months of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With hSBA ≥1:4 | 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. | At 40 and 60 months of age | 
| GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | 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. | At 40 and 60 months of age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prevention of Meningococcal disease