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

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in comparison to licensed meningococcal polysaccharide vaccine administered to healthy adolescents ages 11 to 17 years.

Official Title
-----------------
A Phase 2, Randomized, Single-blind, Controlled, Multicenter Study to Compare the Safety and Immune Response of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine With the Safety and Immune Response of One Dose of Licensed Meningococcal ACWY Polysaccharide Vaccine Administered to Healthy Adolescents 11 to 17 Years of Age

Conditions
-----------------
Prevention of Meningococcal Disease

Intervention / Treatment
-----------------
* Biological: MenACWY-CRM conjugate vaccine, adjuvanted
* Biological: MenACWY-CRM conjugate vaccine, unadjuvanted
* Biological: MenACWY polysaccharide vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adolescents between and including 11-17 years of age, who provide written informed consent Exclusion Criteria: 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
-----------------
Minimum Age: 11 Years
Maximum Age: 17 Years

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MenACWY-CRM(Ad+)<br>Subjects received one single dose of adjuvanted formulation of conjugate vaccine. | Biological: MenACWY-CRM conjugate vaccine, adjuvanted<br> <br> |
| Experimental: MenACWY-CRM(Ad-)<br>Subjects received one single dose of unadjuvanted formulation of conjugate vaccine. | Biological: MenACWY-CRM conjugate vaccine, unadjuvanted<br> <br> |
| Active Comparator: MenACWY- PS<br>Subjects received one single dose of the polysaccharide vaccine. | Biological: MenACWY polysaccharide vaccine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentages of Subjects With N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, or MenACWY-PS Vaccine | Immune response of a single dose of MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant compared to that of one dose of MenACWY polysaccharide (PS) vaccine, one month after administration to subjects aged 11 to 17 years, as measured by the percentage of subjects with hSBA titers >1:4 directed against N meningitidis serogroups A, C, W and Y | 1 month after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hSBA Geometric Mean Titers (GMT) After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant or MenACWY-PS Vaccine | Immune response of one dose of MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine, one month after administration in subjects 11 to 17 years of age, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W, and Y. | 1 month after vaccination | 
| Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine | Immune response of one dose of MenACWY-CRM(Ad-) compared to that of one dose of MenACWY polysaccharide(MenACWY-PS) vaccine, 12 months after administration to subjects aged 11 to 17 years, as measured by the percentage of subjects with human complement serum bactericidal activity (hSBA) titers≥1:4 against N meningitidis serogroups A, C, W, and Y. The endpoint point compares only data of unadjuvanted formulation of the conjugate vaccine to the polysaccharide vaccine. | 12 months after vaccination | 
| hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine | Immune response of one dose of MenACWY-CRM(Ad-) conjugate vaccine compared with that of MenACWY-PS vaccine, 12 months after administration in subjects 11 to 17 years of age, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W, and Y.The endpoint compares only data of unadjuvanted formulation of the conjugate vaccine to the polysaccharide vaccine. | 12 months after vaccination | 
| Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination | Safety was assessed as the number of subjects 11 to 17 years of age who reported solicited local and systemic adverse events from day 1 up to and including day 7 after the vaccination of either MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine. | Day 1 to Day 7 |