Evaluation of Meningococcal Immune Response Among Children Who Previously Received MenACWY Conjugate Vaccine
NCT ID: NCT01148017
Last Updated: 2017-08-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
433 participants
INTERVENTIONAL
2010-07-31
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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ACWY - 4
Subjects who had previously received 4 doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in the parent study during their first year of life are administered one booster dose of the same vaccine at 60 months of age.
Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine
ACWY - 2
Subjects who had previously received 1 or 2 doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine
Naïve - 40
Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.
Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine
Naïve - 60
Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.
Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine
Interventions
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Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine
Eligibility Criteria
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Inclusion Criteria
* Group 1 and 2 (Follow up) subjects must be 40 +/- 3 months of age at the time of enrollment and participated in the original V59P14 study (NCT00474526).
* Group 3 and 4 (Naïve) subjects must be healthy, meningococcal vaccine-naïve children ages 40 +/- 3 months (Group 3) or 60 +/-3 months (Group 4) at the time of enrollment, respectively.
Exclusion Criteria
* Subjects who have received any vaccine (excluding influenza vaccines) 28 days preceding enrollment visit. Influenza vaccines (including FluMist®) are excluded for the 14 days prior to the enrollment visit.
* Subjects who have received any meningococcal vaccine since birth (Groups 3 \& 4 -naive) or last study dose in V59P14 (NCT00474526) trial (Groups 1 \& 2 - follow on).
37 Months
63 Months
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Novartis Vaccines
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Vaccines
Role: STUDY_CHAIR
Novartis Vaccines
Locations
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Alabama Clinical Therapeutics 806 St. Vincent's Drive, Suite 615
Birmingham, Alabama, United States
Premier Health Research 9317 Firestone Blvd.
Downey, California, United States
Kaiser Permanente Oakland 3505 Broadway, 6th Floor, Room 624
Oakland, California, United States
Center for Clinical Trials, LLC 16415 S. Colorado Ave., Suite 308
Paramount, California, United States
Center for Clinical Trials, LLC 16660 Paramount Blvd., Suite 301
Paramount, California, United States
Kaiser Permanente Pleasanton 7601 Stoneridge Drive, Second Floor
Pleasanton, California, United States
Kaiser Permanente San Francisco 2200 O'Farrell St., Sixth Floor
San Francisco, California, United States
Kaiser Permanente Santa Clara 710 Lawrence Expressway, Pediatric Clinic Department
Santa Clara, California, United States
Children's Memorial Hospital 2300 Children's Plaza, Box 155
Chicago, Illinois, United States
Kentucky Pediatric/Adult Research 201 South Fifth Street, Suite 102
Bardstown, Kentucky, United States
28 Annapolis Pediatrics, 200 Forbes Street, Suite 200
Annapolis, Maryland, United States
Senders Pediatrics 2054 South Green Road
Cleveland, Ohio, United States
Pediatric Medical Associates 160 West Germantown Pike Suite D2
East Norriton, Pennsylvania, United States
Children's Health Care 2501 West 12th Street
Erie, Pennsylvania, United States
Pennridge Pediatric Associates 270 Main Street
Harleysville, Pennsylvania, United States
Kid's Way Pediatrics 3068 Innovation Way
Hermitage, Pennsylvania, United States
Pediatric Medical Associates 1077 Rydal Road Suite 300
Rydal, Pennsylvania, United States
Pennridge Pediatric Associates 711 Lawn Avenue
Sellersville, Pennsylvania, United States
PEAK Research 2859 Washington Rd., Ste. 412B
Upper Saint Clair, Pennsylvania, United States
Countries
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References
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Klein NP, Block SL, Essink B, Barbi S, Smolenov I, Keshavan P. Antibody persistence and booster response following MenACWY-CRM vaccination in children as assessed by two different assay methods. Vaccine. 2019 Jul 26;37(32):4460-4467. doi: 10.1016/j.vaccine.2019.06.076. Epub 2019 Jul 3.
Other Identifiers
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V59P14E1
Identifier Type: -
Identifier Source: org_study_id
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