- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00450437
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35205, 35244
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Tuscaloosa, Alabama, United States, 35487
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California
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Fremont, California, United States, 94538
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Fresno, California, United States, 93726
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Hayward, California, United States, 94545
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Oakland, California, United States, 94612
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Roseville, California, United States, 95661
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Sacramento, California, United States, 95817
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San Jose, California, United States, 95119
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Colorado
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Denver, Colorado, United States, 80218
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Georgia
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Atlanta, Georgia, United States, 30062
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Marietta, Georgia, United States, 30062
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Woodstock, Georgia, United States, 30189
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Illinois
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Chicago, Illinois, United States, 60614
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Kentucky
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Bardstown, Kentucky, United States, 40004
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Maryland
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Annapolis, Maryland, United States, 21401
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Baltimore, Maryland, United States, 21201
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Frederick, Maryland, United States, 21702
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Massachusetts
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Boston, Massachusetts, United States, 02118
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Fall River, Massachusetts, United States, 02124
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New Hampshire
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Lebanon, New Hampshire, United States, 03756
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Ohio
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Akron, Ohio, United States, 44308
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Cincinnati, Ohio, United States, 45229
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South Euclid, Ohio, United States, 44121
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Pennsylvania
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Carnegie, Pennsylvania, United States, 15106
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Erie, Pennsylvania, United States, 16505
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Greenville, Pennsylvania, United States, 16125
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Grove City, Pennsylvania, United States, 16127
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Harleyville, Pennsylvania, United States, 19438
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Jefferson Borough, Pennsylvania, United States, 15025
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Latrobe, Pennsylvania, United States, 15650
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Pittsburgh, Pennsylvania, United States, 15217 to 15241
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Sellersville, Pennsylvania, United States, 18960
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Uniontown, Pennsylvania, United States, 15401
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Upper St. Clair, Pennsylvania, United States, 15241
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Washington, Pennsylvania, United States, 15301
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Wexford, Pennsylvania, United States, 15090
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Texas
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Galveston, Texas, United States, 77555-0371
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Utah
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Salt Lake City, Utah, United States, 84121
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Washington
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Seattle, Washington, United States, 98101-1466
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Licensed Meningococcal Vaccine
Licensed meningococcal ACWY polysaccharide-protein conjugate vaccine
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One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
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EXPERIMENTAL: Novartis MenACWY Conjugate Vaccine
Novartis meningococcal ACWY conjugate Vaccine
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One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
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What is the study measuring?
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
Time Frame: 28 days after vaccination
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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)
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28 days after vaccination
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Percentage of Seroresponders, Ages 11 to 18 Years
Time Frame: 28 days after vaccination
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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
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Number of Participants With at Least One Severe Systemic Reaction, Ages 11 to 55 Years
Time Frame: 6 days after vaccination
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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
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Percentage of Seroresponders, Ages 19 to 55 Years
Time Frame: 28 days after vaccination
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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
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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
Time Frame: 28 days after vaccination
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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
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Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years
Time Frame: 28 days after vaccination
|
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
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Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years
Time Frame: 28 days after vaccination
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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).
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28 days after vaccination
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Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years
Time Frame: Days 1 to 7
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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).
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Days 1 to 7
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Infections
- Central Nervous System Infections
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Meningitis, Bacterial
- Central Nervous System Bacterial Infections
- Neisseriaceae Infections
- Meningitis, Meningococcal
- Meningitis
- Meningococcal Infections
Other Study ID Numbers
- V59P13
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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