A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Healthy Adults

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

Official Title
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A Phase 3, Multi-center Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adults and Compare to the Safety and Immune Response of a Licensed Conjugate Meningococcal ACWY Vaccine in Subjects Aged 19-55 Years of Age and to a Licensed Polysaccharide Vaccine in Subjects Aged 56-65 Years of Age.

Conditions
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Meningococcal Meningitis, Meningococcal Infections

Intervention / Treatment
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* Biological: Meningococcal ACWY Polysaccharide Vaccine
* Biological: MenACWY CRM (19 to 55 years)
* Biological: Meningococcal ACWY Conjugate Vaccine
* Biological: Novartis MenACWY Vaccine (56 to 65 Years)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: individuals who are 19-65 years of age inclusive and who, after the nature of the study has been explained have provided written informed consent individuals who are available for all visits and telephone calls scheduled for the study; individuals who are in good health Exclusion Criteria: individuals with a previous or suspected disease caused by N. meningitidis individuals with previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) individuals with previous or suspected disease caused by N. meningitidis individuals with any serious acute, chronic or progressive disease individuals who are pregnant or breastfeeding

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Experimental: Novartis MenACWY Vaccine (19 to 55 Years)<br>Novartis meningococcal ACWY conjugate vaccine administered to subjects 19 years to 55 years | Biological: MenACWY CRM (19 to 55 years)<br>* One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection to subjects 19 years to 55 years of age.<br>|
| Active Comparator: Licensed polysaccharide vaccine<br>Licensed meningococcal ACWY polysaccharide vaccine | Biological: Meningococcal ACWY Polysaccharide Vaccine<br>* One dose of the licensed meningococcal ACWY polysaccharide vaccine was administered by subcutaneous injection.<br>|
| Active Comparator: Licensed Conjugate 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 by intramuscular injection.<br>|
| Experimental: Novartis MenACWY Vaccine (56 to 65 Years)<br>Novartis meningococcal ACWY conjugate vaccine administered to subjects 56 years to 65 years | Biological: Novartis MenACWY Vaccine (56 to 65 Years)<br>* One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection administered to subjects 56 years to 65 years of age.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With at Least One Severe Systemic Reaction, Ages 19 to 55 Years | Safety of the Novartis MenACWY conjugate vaccine and of a licensed meningococcal ACWY conjugate vaccine as measured by the number of subjects presenting at least one severe systemic reaction during the first 7 days following a single vaccination in healthy subjects. | Days 1 to 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population | Immunogenicity of the MenACWY vaccine and of a licensed meningococcal ACWY conjugate vaccine, defined as percentage of subjects with seroresponse, human Serum Bactericidal Activity (hSBA) ≥ 1:8 directed against N meningitidis serogroups A, C, W, and Y (healthy subjects aged 19 to 55 years). Seroresponse: 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. | 1 month postvaccination | 
| Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population | Immunogenicity of the MenACWY vaccine and of a licensed meningococcal ACWY conjugate vaccine, defined as percentage of subjects with seroresponse, human Serum Bactericidal Activity (hSBA) ≥ 1:8 directed against N meningitidis serogroups A, C, W, and Y (healthy subjects aged 56 to 65 years). Seroresponse: 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. | 1 month postvaccination | 
| Summary of hSBA GMTs (Ages 19 to 55 Years), PP Population | Immunogenicity of a single dose of MenACWY and of a single dose of the licensed meningococcal ACWY conjugate vaccine, as measured by serum bactericidal activity geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N meningitidis serogroups A, C, W-135, and Y at 1 month after vaccination, when administered to healthy subjects 19 to 55 years of age. | 1 month postvaccination | 
| Summary of hSBA GMTs (Ages 56 to 65 Years), PP Population | Immunogenicity of a single dose of MenACWY and of a single dose of the licensed meningococcal ACWY conjugate vaccine, as measured by serum bactericidal activity geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N meningitidis serogroups A, C, W-135, and Y at 1 month after vaccination, when administered to healthy subjects 56 to 65 years of age. | 1 month postvaccination | 
| Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years | Safety profile following a single vaccination of MenACWY CRM vaccine and of a single vaccination of a licensed meningococcal ACWY conjugate vaccine administered to healthy subjects (ages 19 to 55 years). | Days 1 to 7 | 
| Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years | Safety profile following a single vaccination of MenACWY vaccine and of a single vaccination of a licensed meninococcal ACWY polysaccharide vaccine administered to healthy subjects (ages 56 to 65 years). | 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