A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults

Study Overview
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Brief Summary
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This study will evaluate the lot to lot consistency, safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine in healthy US adolescents and adults.

Official Title
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A Phase 3, Multi-center Study to Evaluate Lot to Lot Consistency, Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults and Compare to the Safety and Immune Response to a Licensed Conjugate Meningococcal ACWY Vaccine

Conditions
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Meningococcal Infections, Meningococcal Meningitis

Intervention / Treatment
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* Biological: MenACWY CRM
* Biological: Meningococcal ACWY Conjugate vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects who are 11-55 years of age inclusive and who have given appropriate written assent and/or consent Exclusion Criteria: Subjects with a previous or suspected disease caused by N. meningitidis previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) previous or suspected disease caused by N. meningitidis Any serious acute, chronic or progressive disease Pregnant or breastfeeding

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Licensed Meningococcal Vaccine<br>Licensed meningococcal ACWY polysaccharide-protein conjugate vaccine | Biological: Meningococcal ACWY Conjugate vaccine<br>* One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.<br>|
| Experimental: Novartis MenACWY Conjugate Vaccine<br>Novartis meningococcal ACWY conjugate Vaccine | Biological: MenACWY CRM<br>* One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years | The consistency of immune response for the three lots of Meningococcal ACWY (MenACWY), as measured by human serum bactericidal activity (hSBA) geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N. meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 18 years of age) | 28 days after vaccination | 
| Percentage of Seroresponders, Ages 11 to 18 Years | Immunogenicity of a single injection of Meningococcal ACWY (3 lots pooled) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroresponse directed against N meningitidis serogroups A, C, W, and Y (healthy adolescents 11 to 18 years of age). Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. | 28 days after vaccination | 
| Number of Participants With at Least One Severe Systemic Reaction, Ages 11 to 55 Years | Safety of Novartis Meningococcal ACWY and of a licensed meningococcal ACWY conjugate vaccine as measured by the number of participants presenting at least one severe systemic reaction during the first 7 days (Days 1-7) following a single vaccination. Note: severe adverse events: unable to perform normal daily activity | 6 days after vaccination | 
| Percentage of Seroresponders, Ages 19 to 55 Years | Immunogenicity of a single injection of Meningococcal ACWY (3 lots pooled) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroreponse directed against N. meningitidis serogroups A, C, W, and Y (healthy subjects 19 to 55 years of Age). Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. | 28 days after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lot to Lot Consistency for the Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and ≥ 1:4, Ages 11 to 18 Years | The consistency of the immune response for three lots of Meningococcal ACWY, as measured by the percentage of subjects with seroresponse, hSBA titer ≥ 1:4 and ≥ 1:8, directed against N meningitidis serogroups A, C, W, and Y (healthy adolescents 11 to 18 years of age). Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. | 28 days after vaccination | 
| Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years | Immunogenicity of a single injection of MenACWY (3 lots combined) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroresponse directed against N meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 55 years of age). Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. | 28 days after vaccination | 
| Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years | Immunogenicity of a single injection of MenACWY (3 lots combined) to that of a single injection of a licensed meningococcal ACWY conjugate vaccine, as measured by hSBA GMTs directed against N meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 55 years of age). | 28 days after vaccination | 
| Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years | Safety profile following a single injection of MenACWY (3 lots combined) was to that following a single injection of a licensed meningococcal ACWY conjugate vaccine administered to healthy adolescents or adults (11 to 55 years of age). | Days 1 to 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meningococcal, meningitis, vaccine, adolescents, adults