A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Healthy Adults
Primary Purpose
Meningococcal Meningitis, Meningococcal Infections
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Meningococcal ACWY Polysaccharide Vaccine
MenACWY CRM (19 to 55 years)
Meningococcal ACWY Conjugate Vaccine
Novartis MenACWY Vaccine (56 to 65 Years)
Sponsored by
About this trial
This is an interventional prevention trial for Meningococcal Meningitis focused on measuring Meningococcal, meningitis, vaccine, adolescents, adults
Eligibility Criteria
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
Sites / Locations
- Buenos Aires, Argentina
- Cali, Colombia; Bogota, Colombia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
Experimental
Arm Label
Novartis MenACWY Vaccine (19 to 55 Years)
Licensed polysaccharide vaccine
Licensed Conjugate Vaccine
Novartis MenACWY Vaccine (56 to 65 Years)
Arm Description
Novartis meningococcal ACWY conjugate vaccine administered to subjects 19 years to 55 years
Licensed meningococcal ACWY polysaccharide vaccine
Licensed meningococcal ACWY polysaccharide-protein conjugate vaccine
Novartis meningococcal ACWY conjugate vaccine administered to subjects 56 years to 65 years
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00474487
Brief Title
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Healthy Adults
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will evaluate the safety and immune response of Novartis Meningococcal ACWY conjugate vaccine in healthy adolescents and adults.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningococcal Meningitis, Meningococcal Infections
Keywords
Meningococcal, meningitis, vaccine, adolescents, adults
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2831 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Novartis MenACWY Vaccine (19 to 55 Years)
Arm Type
Experimental
Arm Description
Novartis meningococcal ACWY conjugate vaccine administered to subjects 19 years to 55 years
Arm Title
Licensed polysaccharide vaccine
Arm Type
Active Comparator
Arm Description
Licensed meningococcal ACWY polysaccharide vaccine
Arm Title
Licensed Conjugate Vaccine
Arm Type
Active Comparator
Arm Description
Licensed meningococcal ACWY polysaccharide-protein conjugate vaccine
Arm Title
Novartis MenACWY Vaccine (56 to 65 Years)
Arm Type
Experimental
Arm Description
Novartis meningococcal ACWY conjugate vaccine administered to subjects 56 years to 65 years
Intervention Type
Biological
Intervention Name(s)
Meningococcal ACWY Polysaccharide Vaccine
Intervention Description
One dose of the licensed meningococcal ACWY polysaccharide vaccine was administered by subcutaneous injection.
Intervention Type
Biological
Intervention Name(s)
MenACWY CRM (19 to 55 years)
Intervention Description
One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection to subjects 19 years to 55 years of age.
Intervention Type
Biological
Intervention Name(s)
Meningococcal ACWY Conjugate Vaccine
Intervention Description
One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered by intramuscular injection.
Intervention Type
Biological
Intervention Name(s)
Novartis MenACWY Vaccine (56 to 65 Years)
Intervention Description
One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection administered to subjects 56 years to 65 years of age.
Primary Outcome Measure Information:
Title
Number of Subjects With at Least One Severe Systemic Reaction, Ages 19 to 55 Years
Description
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.
Time Frame
Days 1 to 7
Secondary Outcome Measure Information:
Title
Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population
Description
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.
Time Frame
1 month postvaccination
Title
Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population
Description
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.
Time Frame
1 month postvaccination
Title
Summary of hSBA GMTs (Ages 19 to 55 Years), PP Population
Description
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.
Time Frame
1 month postvaccination
Title
Summary of hSBA GMTs (Ages 56 to 65 Years), PP Population
Description
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.
Time Frame
1 month postvaccination
Title
Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years
Description
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).
Time Frame
Days 1 to 7
Title
Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years
Description
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).
Time Frame
Days 1 to 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines and Diagnostics
Organizational Affiliation
Novartis
Official's Role
Study Director
Facility Information:
Facility Name
Buenos Aires, Argentina
City
Buenos Aires
ZIP/Postal Code
C1406DGI
Country
Argentina
Facility Name
Cali, Colombia; Bogota, Colombia
City
Cali; Bogota
Country
Colombia
12. IPD Sharing Statement
Citations:
PubMed Identifier
20655261
Citation
Stamboulian D, Lopardo G, Lopez P, Cortes-Barbosa C, Valencia A, Bedell L, Karsten A, Dull PM. Safety and immunogenicity of an investigational quadrivalent meningococcal CRM(197) conjugate vaccine, MenACWY-CRM, compared with licensed vaccines in adults in Latin America. Int J Infect Dis. 2010 Oct;14(10):e868-75. doi: 10.1016/j.ijid.2010.03.017. Epub 2010 Jul 22.
Results Reference
result
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A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Healthy Adults
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