A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Lots of V114 in Healthy Infants (V114-008)
NCT ID: NCT02987972
Last Updated: 2019-10-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
1051 participants
INTERVENTIONAL
2017-03-21
2018-10-04
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
TRIPLE
Study Groups
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V114 Lot 1
Infants will receive a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
V114 Lot 1
Lot 1: Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose
V114 Lot 2
Infants will receive a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
V114 Lot 2
Lot 2: Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose
Prevnar 13™
Infants will receive a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
Prevnar 13™
Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose
Interventions
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V114 Lot 1
Lot 1: Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose
V114 Lot 2
Lot 2: Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose
Prevnar 13™
Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* In good health
Exclusion Criteria
* Known hypersensitivity to any component of the pneumococcal conjugate vaccine or any diphtheria toxoid-containing vaccine
* Known or suspected impairment of immunological function
* History of congenital or acquired immunodeficiency (eg, splenomegaly)
* Mother has documented human immunodeficiency virus (HIV) infection
* Mother has documented hepatitis B surface antigen-positive test result
* Known or history of functional or anatomic asplenia
* History of failure to thrive
* History of a coagulation disorder
* History of autoimmune disease
* Known neurologic or cognitive behavioral disorder
* Expects to require systemic corticosteroids within 30 days after each vaccination during the trial
* Prior administration of a blood transfusion or blood products, including immunoglobulin
* Participated in another clinical trial of an investigational product
* History of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease
6 Weeks
12 Weeks
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Birmingham Pediatric Research ( Site 0043)
Birmingham, Alabama, United States
Southeastern Pediatric Associates, P.A. ( Site 0079)
Dothan, Alabama, United States
Children's Clinic of Jonesboro, PA ( Site 0054)
Jonesboro, Arkansas, United States
Premier Health Research Center, LLC ( Site 0035)
Downey, California, United States
Sherif Khamis MD, Inc. ( Site 0044)
Palmdale, California, United States
Kaiser Permanente - Roseville ( Site 0045)
Roseville, California, United States
Kaiser Permanente Clinical Trial - Sacramento ( Site 0076)
Sacramento, California, United States
Kentucky Pediatric/Adult Research Inc ( Site 0037)
Bardstown, Kentucky, United States
University of Louisville: Pediatric Clinical Trials Unit ( Site 0049)
Louisville, Kentucky, United States
ACC Pediatric Research ( Site 0039)
Haughton, Louisiana, United States
Woburn Pediatric Associates ( Site 0046)
Woburn, Massachusetts, United States
Dundee Clinic ( Site 0063)
Omaha, Nebraska, United States
Child Health Care Associates ( Site 0064)
East Syracuse, New York, United States
State University of New York Upstate Medical University ( Site 0065)
Syracuse, New York, United States
Pediatric Associates of Mt. Carmel, Inc. ( Site 0052)
Cincinnati, Ohio, United States
Senders Pediatrics ( Site 0058)
Cleveland, Ohio, United States
Ohio Pediatric Research Association ( Site 0060)
Dayton, Ohio, United States
Pediatric Medical Associates ( Site 0059)
East Norriton, Pennsylvania, United States
Kid's Way Pediatrics ( Site 0036)
Hermitage, Pennsylvania, United States
Thomas Jefferson University ( Site 0067)
Philadelphia, Pennsylvania, United States
Coastal Pediatric Research ( Site 0070)
Charleston, South Carolina, United States
Holston Medical Group [Kingsport, TN] ( Site 0048)
Kingsport, Tennessee, United States
University of Texas Medical Branch at Galveston ( Site 0056)
Galveston, Texas, United States
University of Texas Medical Branch at Galveston ( Site 0068)
League City, Texas, United States
Wee Care Pediatrics ( Site 0042)
Layton, Utah, United States
Cottonwood Pediatrics ( Site 0041)
Murray, Utah, United States
Copperview Medical Center ( Site 0062)
South Jordan, Utah, United States
Pediatric Research of Charlottesville, LLC ( Site 0066)
Charlottesville, Virginia, United States
Huguenot Pediatrics ( Site 0057)
Midlothian, Virginia, United States
Family Health Care of Ellensburg ( Site 0077)
Ellensburg, Washington, United States
CHU Ste-Justine ( Site 0084)
Montreal, Quebec, Canada
McGill University Health Centre - Vaccine Study Centre ( Site 0030)
Pierrefonds, Quebec, Canada
CHU de Quebec Universite de Laval ( Site 0031)
Québec, Quebec, Canada
Aarhus Universitetshospital-Skejby-Forskningsklinikken for Kvindesygdomme ( Site 0025)
Aarhus N, , Denmark
OUH Klinisk Forsk center Gyn Obs D. ( Site 0024)
Odense, , Denmark
Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0007)
Espoo, , Finland
Tampereen yliopisto Etela-Helsingin rokotetutkimusklinikka ( Site 0005)
Helsinki, , Finland
Tampereen yliopisto Ita-Helsingin rokotetutkimusklinikka ( Site 0006)
Helsinki, , Finland
Tampereen yliopisto Järvenpään rokotetutkimusklinikka ( Site 0003)
Järvenpää, , Finland
Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0004)
Oulu, , Finland
Tampereen yliopisto Porin rokotetutkimusklinikka ( Site 0008)
Pori, , Finland
Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0001)
Tampere, , Finland
Tampereen yliopisto Turun rokotetutkimusklinikka ( Site 0002)
Turku, , Finland
Soroka University Medical Center ( Site 0019)
Beersheba, , Israel
Soroka University Medical Center - Rahat Family health center ( Site 0020)
Beersheba, , Israel
Soroka University Medical Center - Ramot Family health center ( Site 0021)
Beersheba, , Israel
Soroka University Medical Center - Vav Family health center ( Site 0022)
Beersheba, , Israel
Hospital Clinico Universitario de Santiago ( Site 0016)
Santiago de Compostela, , Spain
Unidad de Estudios e Investigacion IHP ( Site 0017)
Seville, , Spain
Countries
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References
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Platt HL, Greenberg D, Tapiero B, Clifford RA, Klein NP, Hurley DC, Shekar T, Li J, Hurtado K, Su SC, Nolan KM, Acosta CJ, McFetridge RD, Bickham K, Musey LK; V114-008 Study Group. A Phase II Trial of Safety, Tolerability and Immunogenicity of V114, a 15-Valent Pneumococcal Conjugate Vaccine, Compared With 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants. Pediatr Infect Dis J. 2020 Aug;39(8):763-770. doi: 10.1097/INF.0000000000002765.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2016-001117-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
V114-008
Identifier Type: -
Identifier Source: org_study_id
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