Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life
NCT ID: NCT01214837
Last Updated: 2018-10-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
751 participants
INTERVENTIONAL
2010-10-31
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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MenACWY3
Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
MenACWY-CRM
This group received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
Routine Vaccines
Each 0.5 mL dose of the pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) is formulated to contain approximately 2.2 μg of each of Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F saccharides.
MenACWY4
All the subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
MenACWY-CRM
This group received a 3-dose primary series at 2, 4, and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
Routine Vaccines
Each 0.5 mL dose of the pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) is formulated to contain approximately 2.2 μg of each of Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F saccharides.
Routine Vaccines
Subjects received routine vaccines only, including PCV-13, at 2, 4 and 6 months of age and a toddler dose at 12 months of age.
Routine Vaccines
Each 0.5 mL dose of the pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) is formulated to contain approximately 2.2 μg of each of Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F saccharides.
Interventions
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MenACWY-CRM
This group received a 3-dose primary series at 2, 4, and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
MenACWY-CRM
This group received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
Routine Vaccines
Each 0.5 mL dose of the pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) is formulated to contain approximately 2.2 μg of each of Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F saccharides.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
55 Days
89 Days
ALL
Yes
Sponsors
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Novartis Vaccines
INDUSTRY
Responsible Party
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Locations
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Birmingham, Alabama, United States
Fayetteville, Arkansas, United States
Jonesboro, Arkansas, United States
Little Rock, Arkansas, United States
Fountain Valley, California, United States
Huntington Beach, California, United States
Madera, California, United States
Nampa, Idaho, United States
Cotton ONeil Clinical Research
Topeka, Kansas, United States
Cotton ONeil Clinical Research
Topeka, Kansas, United States
Bardstown, Kentucky, United States
Bluegrass Clinical Research (Bardstown Road)
Louisville, Kentucky, United States
Bluegrass Clinical Research (Brownsboro Park Blvd)
Louisville, Kentucky, United States
Springfield, Kentucky, United States
Haughton, Louisiana, United States
Shreveport, Louisiana, United States
Niles, Michigan, United States
Lincoln, Nebraska, United States
Children's Physicians Dundee
Omaha, Nebraska, United States
Creighton Univ
Omaha, Nebraska, United States
Binghamton, New York, United States
Johnson City, New York, United States
Syracuse, New York, United States
Dayton, Ohio, United States
Huber Heights, Ohio, United States
Kettering, Ohio, United States
Tulsa, Oklahoma, United States
Kingsport, Tennessee, United States
Lebanon, Tennessee, United States
San Antonio, Texas, United States
Tomball, Texas, United States
Layton, Utah, United States
Salt Lake City, Utah, United States
St. George, Utah, United States
Richmond, Virginia, United States
Rockwood Clinic P S
Spokane, Washington, United States
Rockwood Clinic P S
Spokane, Washington, United States
Greater Sudbury, Ontario, Canada
Toronto, Ontario, Canada
Pierrefonds, Quebec, Canada
Countries
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References
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Block SL, Shepard J, Garfield H, Xie F, Han L, Dull PM, Smolenov I. Immunogenicity and Safety of a 3- and 4-dose Vaccination Series of a Meningococcal ACWY Conjugate Vaccine in Infants: Results of a Phase 3b, Randomized, Open-label Trial. Pediatr Infect Dis J. 2016 Feb;35(2):e48-59. doi: 10.1097/INF.0000000000000965.
Other Identifiers
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V59_36
Identifier Type: -
Identifier Source: org_study_id
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