Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Children

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and immunogenicity of Novartis (formerly Chiron) Meningococcal ACWY Conjugate Vaccine administered to healthy children ages 1 - 10 years

Official Title
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A Phase 2, Randomized, Single-blind, Controlled, Single-Center Study to Compare the Safety and Immunogenicity of One Dose of Chiron Meningococcal ACWY Conjugate Vaccine With One Dose of Licensed Meningococcal ACWY Polysaccharide Vaccine Administered to Healthy Children 2-10 Years of Age and an Open-label Study to Assess the Safety and Immunogenicity of One Dose of Chiron Meningococcal ACWY Conjugate Vaccine Administered to Healthy Toddlers 12-23 Months of Age

Conditions
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Prevention of Meningococcal Disease

Intervention / Treatment
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* Biological: MenACWY-CRM Vaccine
* Biological: MenACWY-PS Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Group 1: Healthy children 2-10 years of age; Group 2: Healthy toddlers 12-23 months of age; who are up to date with age appropriate immunizations for diphtheria, tetanus, pertussis, polio, hepatitis B, Hemophilus influenzae type b, and pneumococcus. Exclusion Criteria: Group 1: Subjects with a previous or suspected disease caused by N. meningitidis; or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease. Group 2: Subjects with a previous or suspected disease caused by N. meningitidis or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease.

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MenACWY-CRM (2-10 years)<br>Subjects received one dose of investigational MenACWY-CRM conjugate vaccine | Biological: MenACWY-CRM Vaccine<br> <br> |
| Experimental: MenACWY-CRM (12-23 months)<br>Subjects received one dose of investigational MenACWY-CRM conjugate vaccine | Biological: MenACWY-CRM Vaccine<br> <br> |
| Active Comparator: MenACWY-PS (2-10 years)<br>Subjects received one dose of licensed comparator MenACWY polysaccharide (MenACWY-PS) vaccine | Biological: MenACWY-PS Vaccine<br> <br> |
| Experimental: MenACWY-CRM+PnC (12-15 months)<br>Subjects received one dose of MenACWY-CRM vaccine alone or concomitantly with PnC | Biological: MenACWY-CRM Vaccine<br> <br> |
| Experimental: MenACWY-CRM+DTaP (16-23 months)<br>Subjects received one dose of MenACWY-CRM vaccine alone or concomitantly with DTaP | Biological: MenACWY-CRM Vaccine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine | Number of subjects (2-10 years of age) achieving with hSBA titers ≥1:4 against Neisseria meningitidis serogroups A,C,W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine. | 1 month post vaccination (Day 29) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine | Percentages of subjects (2-5 years of age and 6-10 years of age) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine. | 1 month post vaccination (Day 29) | 
| Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine | Percentage of subjects (12-23 months old) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y after receiving one dose of MenACWY-CRM vaccine compared with percentage of subjects (3-5 years old) with hSBA ≥ 1:4 after one dose of licensed MenACWY-PS vaccine. | 1 month post vaccination (Day 29) | 
| hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine | hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-10 years of age), one month after receiving one dose of either MenACWY-CRM vaccine or the licensed MenACWY-PS vaccine. | 1 month post vaccination (Day 29) | 
| hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine | hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-5 years of age and 6-10 years of age), one month after receiving one dose of either MenACWY-CRM vaccine or licensed MenACWY-PS vaccine. | 1 month post vaccination (Day 29) | 
| hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine | hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (12-23 months old), one month after receiving one dose of MenACWY-CRM vaccine compared with hSBA GMT in 3-5 year old subjects after receiving one dose of licensed MenACWY-PS vaccine. | 1 month post vaccination (Day 29) | 
| Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine | Number of subjects (2-10 years, 2-5 years and 6-10 years old subjects) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y, 12 months after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine. | 12 months post vaccination (Day 360) | 
| hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine | hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-10 years, 2-5 years and 6-10 years old), twelve months after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine. | 12 months post vaccination (Day 360) | 
| Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years | Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine compared to the safety and tolerability of a single dose of licensed MenACWY-PS vaccine when administered to healthy children 2 to 10 years of age. | Day 1 to 7 post vaccination | 
| Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months | Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine when administered in healthy toddlers (12-15 months old), alone or concomitantly with PnC and when administered in healthy toddlers (16-23 months old), alone or concomitantly with DTaP. | Day 1 to 7 post vaccination | 
| Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years | Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine compared to the safety and tolerability of a single dose of licensed MenACWY-PS vaccine when administered to healthy children 2 to 10 years of age. | Day 1- Day 360 (throughout the study) | 
| Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months | Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine when administered in healthy toddlers (12-15 months old), alone or concomitantly with PnC and when administered in healthy toddlers (16-23 months old), alone or concomitantly with DTaP. | Day 1- Day 360 (Throughout the study) |