Back to resultsA Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults
Primary Purpose
Meningococcal Infections, Meningococcal Meningitis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
MenACWY CRM
Meningococcal ACWY Conjugate vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Meningococcal Infections focused on measuring Meningococcal, meningitis, vaccine, adolescents, adults
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Licensed Meningococcal Vaccine
Novartis MenACWY Conjugate Vaccine
Arm Description
Licensed meningococcal ACWY polysaccharide-protein conjugate vaccine
Novartis meningococcal ACWY conjugate Vaccine
Outcomes
Primary Outcome Measures
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)
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.
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
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.
Secondary Outcome Measures
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.
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.
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).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00450437
Brief Title
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
January 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 lot to lot consistency, safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine in healthy US adolescents and adults.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningococcal Infections, Meningococcal Meningitis
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
3539 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Licensed Meningococcal Vaccine
Arm Type
Active Comparator
Arm Description
Licensed meningococcal ACWY polysaccharide-protein conjugate vaccine
Arm Title
Novartis MenACWY Conjugate Vaccine
Arm Type
Experimental
Arm Description
Novartis meningococcal ACWY conjugate Vaccine
Intervention Type
Biological
Intervention Name(s)
MenACWY CRM
Intervention Description
One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
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 intramuscularly.
Primary Outcome Measure Information:
Title
Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years
Description
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)
Time Frame
28 days after vaccination
Title
Percentage of Seroresponders, Ages 11 to 18 Years
Description
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.
Time Frame
28 days after vaccination
Title
Number of Participants With at Least One Severe Systemic Reaction, Ages 11 to 55 Years
Description
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
Time Frame
6 days after vaccination
Title
Percentage of Seroresponders, Ages 19 to 55 Years
Description
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.
Time Frame
28 days after vaccination
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
28 days after vaccination
Title
Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years
Description
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.
Time Frame
28 days after vaccination
Title
Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years
Description
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).
Time Frame
28 days after vaccination
Title
Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years
Description
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).
Time Frame
Days 1 to 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines and Diagnostics
Organizational Affiliation
Novartis
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205, 35244
Country
United States
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35487
Country
United States
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
City
Fresno
State/Province
California
ZIP/Postal Code
93726
Country
United States
City
Hayward
State/Province
California
ZIP/Postal Code
94545
Country
United States
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
City
San Jose
State/Province
California
ZIP/Postal Code
95119
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30062
Country
United States
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30062
Country
United States
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02124
Country
United States
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
City
South Euclid
State/Province
Ohio
ZIP/Postal Code
44121
Country
United States
City
Carnegie
State/Province
Pennsylvania
ZIP/Postal Code
15106
Country
United States
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16505
Country
United States
City
Greenville
State/Province
Pennsylvania
ZIP/Postal Code
16125
Country
United States
City
Grove City
State/Province
Pennsylvania
ZIP/Postal Code
16127
Country
United States
City
Harleyville
State/Province
Pennsylvania
ZIP/Postal Code
19438
Country
United States
City
Jefferson Borough
State/Province
Pennsylvania
ZIP/Postal Code
15025
Country
United States
City
Latrobe
State/Province
Pennsylvania
ZIP/Postal Code
15650
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15217 to 15241
Country
United States
City
Sellersville
State/Province
Pennsylvania
ZIP/Postal Code
18960
Country
United States
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
City
Upper St. Clair
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
City
Washington
State/Province
Pennsylvania
ZIP/Postal Code
15301
Country
United States
City
Wexford
State/Province
Pennsylvania
ZIP/Postal Code
15090
Country
United States
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0371
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101-1466
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19476428
Citation
Jackson LA, Baxter R, Reisinger K, Karsten A, Shah J, Bedell L, Dull PM; V59P13 Study Group. Phase III comparison of an investigational quadrivalent meningococcal conjugate vaccine with the licensed meningococcal ACWY conjugate vaccine in adolescents. Clin Infect Dis. 2009 Jul 1;49(1):e1-10. doi: 10.1086/599117.
Results Reference
result
PubMed Identifier
19812260
Citation
Reisinger KS, Baxter R, Block SL, Shah J, Bedell L, Dull PM. Quadrivalent meningococcal vaccination of adults: phase III comparison of an investigational conjugate vaccine, MenACWY-CRM, with the licensed vaccine, Menactra. Clin Vaccine Immunol. 2009 Dec;16(12):1810-5. doi: 10.1128/CVI.00207-09. Epub 2009 Oct 7.
Results Reference
result
Learn more about this trial
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults
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