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
1 other identifier
interventional
3,539
1 country
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2007
Shorter than P25 for phase_3
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 21, 2007
CompletedFirst Posted
Study publicly available on registry
March 22, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedResults Posted
Study results publicly available
September 24, 2010
CompletedJanuary 28, 2015
January 1, 2015
5 months
March 21, 2007
March 19, 2010
January 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (4)
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
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
28 days after vaccination
Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years
28 days after vaccination
Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years
Days 1 to 7
Study Arms (2)
Licensed Meningococcal Vaccine
ACTIVE COMPARATORLicensed meningococcal ACWY polysaccharide-protein conjugate vaccine
Novartis MenACWY Conjugate Vaccine
EXPERIMENTALNovartis meningococcal ACWY conjugate Vaccine
Interventions
One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
Eligibility Criteria
You may qualify if:
- Healthy subjects who are 11-55 years of age inclusive and who have given appropriate written assent and/or consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Unknown Facility
Birmingham, Alabama, 35205, 35244, United States
Unknown Facility
Tuscaloosa, Alabama, 35487, United States
Unknown Facility
Fremont, California, 94538, United States
Unknown Facility
Fresno, California, 93726, United States
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Hayward, California, 94545, United States
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Oakland, California, 94612, United States
Unknown Facility
Roseville, California, 95661, United States
Unknown Facility
Sacramento, California, 95817, United States
Unknown Facility
San Jose, California, 95119, United States
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Denver, Colorado, 80218, United States
Unknown Facility
Atlanta, Georgia, 30062, United States
Unknown Facility
Marietta, Georgia, 30062, United States
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Woodstock, Georgia, 30189, United States
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Chicago, Illinois, 60614, United States
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Bardstown, Kentucky, 40004, United States
Unknown Facility
Annapolis, Maryland, 21401, United States
Unknown Facility
Baltimore, Maryland, 21201, United States
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Frederick, Maryland, 21702, United States
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Boston, Massachusetts, 02118, United States
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Fall River, Massachusetts, 02124, United States
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Lebanon, New Hampshire, 03756, United States
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Akron, Ohio, 44308, United States
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Cincinnati, Ohio, 45229, United States
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South Euclid, Ohio, 44121, United States
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Carnegie, Pennsylvania, 15106, United States
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Erie, Pennsylvania, 16505, United States
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Greenville, Pennsylvania, 16125, United States
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Grove City, Pennsylvania, 16127, United States
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Harleyville, Pennsylvania, 19438, United States
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Jefferson Borough, Pennsylvania, 15025, United States
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Latrobe, Pennsylvania, 15650, United States
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Pittsburgh, Pennsylvania, 15217 to 15241, United States
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Sellersville, Pennsylvania, 18960, United States
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Uniontown, Pennsylvania, 15401, United States
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Upper Saint Clair, Pennsylvania, 15241, United States
Unknown Facility
Washington, Pennsylvania, 15301, United States
Unknown Facility
Wexford, Pennsylvania, 15090, United States
Unknown Facility
Galveston, Texas, 77555-0371, United States
Unknown Facility
Salt Lake City, Utah, 84121, United States
Unknown Facility
Seattle, Washington, 98101-1466, United States
Related Publications (2)
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.
PMID: 19476428RESULTReisinger 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.
PMID: 19812260RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Posting Director
- Organization
- Novartis Vaccines and Diagnostics
Study Officials
- STUDY DIRECTOR
Novartis Vaccines and Diagnostics
Novartis
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2007
First Posted
March 22, 2007
Study Start
March 1, 2007
Primary Completion
August 1, 2007
Study Completion
January 1, 2008
Last Updated
January 28, 2015
Results First Posted
September 24, 2010
Record last verified: 2015-01