Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029)
NCT ID: NCT03893448
Last Updated: 2023-07-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1720 participants
INTERVENTIONAL
2019-06-19
2021-05-24
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
Participants receive 4 total 0.5 mL intramuscular (IM) vaccinations at \~2, 4, 6, and 12 to 15 months of age. Participants will receive other vaccinations (i.e., RotaTeq™, Pentacel™, RECOMBIVAX HB™, VAQTA™, M-M-R II™, VARIVAX™, and HIBERIX™) as part of their vaccination schedule.
V114
V114 15-valent pneumococcal conjugate vaccine containing 13 serotypes present in Prevnar 13® (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) and 2 unique serotypes (22F and 33F) in each 0.5 mL intramuscular administration.
RotaTeq™
A total of 3 RotaTeq™ 2 mL oral dosings at \~2, \~4, and \~6 months of age.
Pentacel™
A total of 3 Pentacel™ 0.5 mL IM dosings at \~2, \~4, and \~6 months of age.
RECOMBIVAX HB™
A total of 3 RECOMBIVAX HB™ 0.5 mL IM dosings at \~2, \~4, and \~6 months of age.
VAQTA™
One VAQTA™ 0.5 mL IM dosing at 12 to 15 months of age.
MMR II™
One MMR II™ 0.5 mL subcutaneous (SC) dosing at 12 to 15 months of age.
VARIVAX™
One VARIVAX™ 0.5 mL SC dosing at 12 to 15 months of age.
HIBERIX™
One HIBERIX™ 0.5 mL IM dosing at Visit 5.
Prevnar 13™
Participants receive 4 total 0.5 mL IM vaccinations at \~2, 4, 6, and 12 to 15 months of age. Participants will also receive other vaccines (i.e., RotaTeq™, Pentacel™, RECOMBIVAX HB™, VAQTA™, M-M-R II™, VARIVAX™, and HIBERIX™) as part of their vaccination schedule.
Prevnar 13™
Prevnar 13™ 13-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL IM administration.
RotaTeq™
A total of 3 RotaTeq™ 2 mL oral dosings at \~2, \~4, and \~6 months of age.
Pentacel™
A total of 3 Pentacel™ 0.5 mL IM dosings at \~2, \~4, and \~6 months of age.
RECOMBIVAX HB™
A total of 3 RECOMBIVAX HB™ 0.5 mL IM dosings at \~2, \~4, and \~6 months of age.
VAQTA™
One VAQTA™ 0.5 mL IM dosing at 12 to 15 months of age.
MMR II™
One MMR II™ 0.5 mL subcutaneous (SC) dosing at 12 to 15 months of age.
VARIVAX™
One VARIVAX™ 0.5 mL SC dosing at 12 to 15 months of age.
HIBERIX™
One HIBERIX™ 0.5 mL IM dosing at Visit 5.
Interventions
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V114
V114 15-valent pneumococcal conjugate vaccine containing 13 serotypes present in Prevnar 13® (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) and 2 unique serotypes (22F and 33F) in each 0.5 mL intramuscular administration.
Prevnar 13™
Prevnar 13™ 13-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL IM administration.
RotaTeq™
A total of 3 RotaTeq™ 2 mL oral dosings at \~2, \~4, and \~6 months of age.
Pentacel™
A total of 3 Pentacel™ 0.5 mL IM dosings at \~2, \~4, and \~6 months of age.
RECOMBIVAX HB™
A total of 3 RECOMBIVAX HB™ 0.5 mL IM dosings at \~2, \~4, and \~6 months of age.
VAQTA™
One VAQTA™ 0.5 mL IM dosing at 12 to 15 months of age.
MMR II™
One MMR II™ 0.5 mL subcutaneous (SC) dosing at 12 to 15 months of age.
VARIVAX™
One VARIVAX™ 0.5 mL SC dosing at 12 to 15 months of age.
HIBERIX™
One HIBERIX™ 0.5 mL IM dosing at Visit 5.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent.
Exclusion Criteria
* Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), any component of the licensed pediatric vaccines to be administered concomitantly in the study, or any diphtheria toxoid-containing vaccine.
* Has any contraindication to the concomitant study vaccines being administered in the study.
* Had a recent febrile illness (rectal temperature ≥38.1°C \[=100.5°F\] or axillary temperature ≥37.8°C \[=100.0°F\]) occurring within 72 hours prior to receipt of study vaccine.
42 Days
90 Days
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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Alabama Clinical Therapeutics ( Site 0159)
Birmingham, Alabama, United States
Southeastern Pediatric Associates, P.A. ( Site 0107)
Dothan, Alabama, United States
South Alabama Pediatrics ( Site 0263)
Opp, Alabama, United States
Northwest Arkansas Pediatric Clinic ( Site 0172)
Fayetteville, Arkansas, United States
Children's Clinic of Jonesboro, PA ( Site 0184)
Jonesboro, Arkansas, United States
Advanced Clinical Research - Rancho Paseo ( Site 0163)
Banning, California, United States
Altissima Clinical Research LLC ( Site 0213)
Bellflower, California, United States
Southland Clinical Research Center ( Site 0187)
Bellflower, California, United States
Premier Health Research Center, LLC ( Site 0121)
Downey, California, United States
Kaiser Permanente Vaccine Study Center - Oakland ( Site 0282)
Oakland, California, United States
Kaiser Permanente - Sacramento ( Site 0257)
Sacramento, California, United States
Kaiser Permanente Vaccine Study Center - South Sacramento ( Site 0256)
Sacramento, California, United States
Kaiser Permanente - San Jose ( Site 0258)
San Jose, California, United States
Kaiser Permanente - Santa Clara ( Site 0244)
Santa Clara, California, United States
Davita Medical Group ( Site 0141)
Colorado Springs, Colorado, United States
Suncoast Research Associates, LLC ( Site 0250)
Miami, Florida, United States
Suncoast Research Associates, LLC ( Site 0249)
North Miami Beach, Florida, United States
Children's Health Center ( Site 0272)
Tampa, Florida, United States
Saltzer Medical Group ( Site 0215)
Nampa, Idaho, United States
Kentucky Pediatric/Adult Research Inc ( Site 0136)
Bardstown, Kentucky, United States
Michael W Simon, MD., Pediatric & Adolescent Medicine ( Site 0276)
Nicholasville, Kentucky, United States
ACC Pediatric Research ( Site 0147)
Haughton, Louisiana, United States
Medpharmics, LLC ( Site 0157)
Metairie, Louisiana, United States
Virgo-Carter Pediatrics ( Site 0275)
Silver Spring, Maryland, United States
Tufts Medical Center-Floating Hospital for Children ( Site 0129)
Boston, Massachusetts, United States
Pediatric Associates of Fall River ( Site 0183)
Fall River, Massachusetts, United States
MediSync Clinical Research Hattiesburg Clinic ( Site 0259)
Petal, Mississippi, United States
Children's Mercy Clinics on Broadway ( Site 0171)
Kansas City, Missouri, United States
Midwest Children's Health Research Institute, LLC ( Site 0109)
Lincoln, Nebraska, United States
Midwest Children's Health Research Institute, LLC ( Site 0106)
Lincoln, Nebraska, United States
Children's Physicians, UNMC ( Site 0252)
Omaha, Nebraska, United States
Southwest CARE Center ( Site 0161)
Santa Fe, New Mexico, United States
Child Health Care Associates ( Site 0242)
East Syracuse, New York, United States
Child Health Care Associates ( Site 0267)
Liverpool, New York, United States
Advantage Clinical Trials ( Site 0274)
The Bronx, New York, United States
Haywood Pediatric and Adolescent Medicine Group ( Site 0248)
Clyde, North Carolina, United States
Capitol Pediatrics & Adolescent Center ( Site 0223)
Raleigh, North Carolina, United States
Senders Pediatrics ( Site 0190)
Cleveland, Ohio, United States
Dayton Clinical Research ( Site 0188)
Dayton, Ohio, United States
Cyn3rgy Research ( Site 0246)
Gresham, Oregon, United States
Pediatric Medical Associates ( Site 0239)
East Norriton, Pennsylvania, United States
Allegheny Health & Wellness Pavilion West ( Site 0210)
Erie, Pennsylvania, United States
Lockman & Lubell Pediatrics ( Site 0166)
Fort Washington, Pennsylvania, United States
CCP- Kid's Way ( Site 0130)
Hermitage, Pennsylvania, United States
Palmetto Pediatrics, PA ( Site 0164)
Charleston, South Carolina, United States
Cheraw Pediatrics ( Site 0280)
Cheraw, South Carolina, United States
Parkside Pediatric ( Site 0125)
Greenville, South Carolina, United States
Holston Medical Group ( Site 0165)
Kingsport, Tennessee, United States
DFW Clinical Research ( Site 0111)
Dallas, Texas, United States
University of Texas Medical Branch ( Site 0185)
Galveston, Texas, United States
Ventavia Research Group LLC ( Site 0142)
Houston, Texas, United States
Pediatric Associates ( Site 0209)
Houston, Texas, United States
Houston Clinical Research Network ( Site 0266)
Houston, Texas, United States
Ventavia Research Group LLC ( Site 0139)
Keller, Texas, United States
FMC Science ( Site 0115)
Lampasas, Texas, United States
University of Texas Medical Branch ( Site 0170)
League City, Texas, United States
DCOL Center for Clinical Research ( Site 0247)
Longview, Texas, United States
Wee Care Pediatrics ( Site 0154)
Layton, Utah, United States
Cottonwood Pediatrics ( Site 0153)
Murray, Utah, United States
Pediatric Care ( Site 0138)
Provo, Utah, United States
Wee Care Pediatrics-Roy ( Site 0174)
Roy, Utah, United States
University of Utah ( Site 0214)
Salt Lake City, Utah, United States
Dixie Pediatrics ( Site 0260)
St. George, Utah, United States
Wee Care Pediatrics ( Site 0193)
Syracuse, Utah, United States
MultiCare Rockwood Cheney Clinic ( Site 0195)
Cheney, Washington, United States
Multicare / Rockwood Clinic ( Site 0167)
Spokane, Washington, United States
Cooperativa de Facultad Medica Sanacoop ( Site 0077)
Bayamón, , Puerto Rico
Clinical Research of Puerto Rico ( Site 0075)
Guayama, , Puerto Rico
CAIMED Center - Ponce School of Medicine ( Site 0076)
Ponce, , Puerto Rico
San Juan Hospital ( Site 0079)
San Juan, , Puerto Rico
University of Puerto Rico - Medical Science Campus ( Site 0078)
San Juan, , Puerto Rico
Elba Antoniette Perez Vargas MD-Private Practice ( Site 0081)
Trujillo Alto, , Puerto Rico
Khon Kaen University ( Site 0031)
Muang, Changwat Khon Kaen, Thailand
Phramongkutklao Hospital ( Site 0033)
Bangkok, , Thailand
Siriraj Hospital ( Site 0032)
Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Hospital ( Site 0030)
Chiang Mai, , Thailand
Cukurova Uni Tip Fak Cocuk Saglıgı ve Hasta ABD ( Site 0060)
Adana, , Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi ( Site 0053)
Ankara, , Turkey (Türkiye)
Ege University Medical Faculty Hospital ( Site 0050)
Izmir, , Turkey (Türkiye)
Dokuz Eylul University Faculty of Medicine ( Site 0054)
Izmir, , Turkey (Türkiye)
Erciyes Universitesi Tip Fakultesi ( Site 0057)
Kayseri, , Turkey (Türkiye)
Countries
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References
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Lupinacci R, Rupp R, Wittawatmongkol O, Jones J, Quinones J, Ulukol B, Dagan R, Richmond P, Stek JE, Romero L, Koseoglu S, Tamms G, McFetridge R, Li J, Cheon K, Musey L, Banniettis N, Bickham K; V114-029 PNEU-PED study group. A phase 3, multicenter, randomized, double-blind, active-comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of a 4-dose regimen of V114, a 15-valent pneumococcal conjugate vaccine, in healthy infants (PNEU-PED). Vaccine. 2023 Jan 27;41(5):1142-1152. doi: 10.1016/j.vaccine.2022.12.054. Epub 2023 Jan 6.
Mt-Isa S, Chumbley JR, Crawford EL, Banniettis N, Buchwald UK, Weaver J, Weiss T. An indirect treatment comparison (ITC) and matching-adjusted indirect comparison (MAIC) between a 15-valent (V114) and a 20-valent (PCV20) pneumococcal conjugate vaccine among healthy infants. Expert Rev Vaccines. 2023 Jan-Dec;22(1):906-917. doi: 10.1080/14760584.2023.2270039. Epub 2023 Oct 19.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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V114-029
Identifier Type: OTHER
Identifier Source: secondary_id
2018-004109-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
V114-029
Identifier Type: -
Identifier Source: org_study_id
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