A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK)
NCT ID: NCT03692871
Last Updated: 2023-07-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2409 participants
INTERVENTIONAL
2018-12-14
2021-03-26
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 will receive a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
V114
V114 pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose
Prevnar 13™
Participants will receive a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
Prevnar 13™
Prevnar 13™ pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each) and 6B (4.4 mcg) in each 0.5 ml dose
Interventions
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V114
V114 pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose
Prevnar 13™
Prevnar 13™ pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each) 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
* Male or female approximately 2 months of age, from 42 days to 90 days inclusive, at the time of obtaining the informed consent
* Have 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
* Known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV) or any diphtheria toxoid containing vaccine
* Known or suspected impairment of immunological function
* History of congenital or acquired immunodeficiency
* Has or his/her mother has a documented human immunodeficiency virus (HIV) infection
* Known or history of functional or anatomic asplenia
* Failure to thrive based on the clinical judgment of the investigator
* Known coagulation disorder contraindicating intramuscular vaccination
* History of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, Behcet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, type 1 diabetes mellitus, or other autoimmune disorders)
* Known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders
* Received a dose of any pneumococcal vaccine prior to study entry
* Received a blood transfusion or blood products, including immunoglobulins, before receipt of first dose of study vaccine
* Participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study. Participants enrolled in observational studies may be included.
* Has any other reason that, in the opinion of the investigator, may interfere with the evaluation required by the study
* Has an immediate family member who is investigational site or Sponsor staff directly involved with this study.
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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Premier Health Research Center, LLC ( Site 0005)
Downey, California, United States
Beach Pediatrics ( Site 0040)
Huntington Beach, California, United States
Khruz Biotechnology Research Institute ( Site 0006)
San Diego, California, United States
Kaiser Permanente - San Jose ( Site 0036)
San Jose, California, United States
Kaiser Permanente - Santa Clara ( Site 0027)
Santa Clara, California, United States
Children's Research, LLC ( Site 0025)
Lake Mary, Florida, United States
Advanced Research For Health Improvement LLC ( Site 0030)
Naples, Florida, United States
Pediatric Partners, P.A. ( Site 0010)
Overland Park, Kansas, United States
Novak Center for Childrens Health ( Site 0033)
Louisville, Kentucky, United States
Medpharmics, LLC ( Site 0037)
Metairie, Louisiana, United States
Child Health Care Associates ( Site 0024)
East Syracuse, New York, United States
Primedical Clinical Research ( Site 0035)
Dayton, Ohio, United States
Allegheny Health & Wellness Pavilion West ( Site 0034)
Erie, Pennsylvania, United States
CCP- Kid's Way ( Site 0008)
Hermitage, Pennsylvania, United States
Thomas Jefferson University ( Site 0029)
Philadelphia, Pennsylvania, United States
Medical Research South, LLC ( Site 0013)
Charleston, South Carolina, United States
Pediatric Associates [Houston, TX] ( Site 0039)
Houston, Texas, United States
University of Texas Medical Branch ( Site 0018)
League City, Texas, United States
Tanner Clinic ( Site 0009)
Layton, Utah, United States
Wee Care Pediatrics ( Site 0031)
Layton, Utah, United States
Wee Care Pediatrics ( Site 0020)
Roy, Utah, United States
University of Wisconsin American Family Children's Hospital ( Site 0023)
Madison, Wisconsin, United States
Monash Children s Hospital ( Site 0093)
Clayton, Victoria, Australia
Perth Children s Hospital ( Site 0092)
Nedlands, , Australia
Children, Youth and Woman's Health Service ( Site 0094)
North Adelaide, , Australia
Alberta Children s Hospital ( Site 0048)
Calgary, Alberta, Canada
Vaccine Evaluation Center BC Children s Hospital Research Institute ( Site 0046)
Vancouver, British Columbia, Canada
IWK Health Centre [Halifax, Canada] ( Site 0043)
Halifax, Nova Scotia, Canada
Medicor Research Inc. ( Site 0041)
Greater Sudbury, Ontario, Canada
Hamilton Medical Research Group ( Site 0049)
Hamilton, Ontario, Canada
CHU Sainte Justine ( Site 0047)
Montreal, Quebec, Canada
McGill University Health Centre - Vaccine Study Centre ( Site 0045)
Pierrefonds, Quebec, Canada
CHUQ - Unite de Recherche en Sante Publique ( Site 0042)
Québec, Quebec, Canada
Espoon rokotetutkimuskeskus ( Site 0066)
Espoo, , Finland
Tampereen yliopisto Etela-Helsingin Rokotetutkimusklinikka ( Site 0064)
Helsinki, , Finland
Ita-Helsingin Rokotetutkimuskeskus ( Site 0065)
Helsinki, , Finland
Jarvenpaan rokotetutkimuskeskus ( Site 0067)
Järvenpää, , Finland
Kokkolan rokotetutkimusklinikka ( Site 0071)
Kokkola, , Finland
Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0072)
Oulu, , Finland
Porin Rokotetutkimusklinikka ( Site 0069)
Pori, , Finland
Seinajoki Vaccine Research Center ( Site 0070)
Seinäjoki, , Finland
Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0063)
Tampere, , Finland
Turun rokotetutkimuskeskus ( Site 0068)
Turku, , Finland
Kinderarztpraxis ( Site 0124)
Aschaffenburg, , Germany
Kinderarztpraxis ( Site 0123)
Bramsche, , Germany
Kinderarztpraxis Dr. Friedrich Kaiser & Dr. Marinesse ( Site 0085)
Hamburg, , Germany
Kinderarztpraxis ( Site 0081)
Hürth, , Germany
Kinderarztpraxis Dr. Muehlschlegel - Dr. Goetz ( Site 0122)
Lauffen am Neckar, , Germany
Kinderarztpraxis ( Site 0080)
Mönchengladbach, , Germany
Kinderarztpraxis Matthias Donner Dr. M. Luechtrath ( Site 0091)
Munchengladbach, , Germany
Kinderarztpraxis ( Site 0084)
Schönau, , Germany
Kinderaerztliche Gemeinschaftspraxis Drs. Westerholt/Matyas ( Site 0083)
Wolfsburg, , Germany
Soroka University Medical Center ( Site 0077)
Beersheba, , Israel
Soroka University Medical Center - Ramot Family health center ( Site 0078)
Beersheba, , Israel
Rambam Medical Center ( Site 0076)
Haifa, , Israel
Rambam Medical Center- Keriat Eliezer Family Health Center ( Site 0138)
Haifa, , Israel
Rambam Medical Center- Neve David Family Health Center ( Site 0139)
Haifa, , Israel
Soroka Medical Center_ Hura Family health center ( Site 0137)
Hura, , Israel
Soroka University Medical Center - Rahat Family health center ( Site 0079)
Rahat, , Israel
Klinik Kesihatan Greentown ( Site 0132)
Ipoh, Perak, Malaysia
Sarawak General Hospital ( Site 0107)
Kuching, Sarawak, Malaysia
Hospital Sibu ( Site 0111)
Sibu, Sarawak, Malaysia
Universiti Malaya Medical Center-Clinical Investigation Center ( Site 0108)
Kuala Lumpur, , Malaysia
Klinik Kesihatan Pandamaran ( Site 0110)
Port Klang, , Malaysia
Hospital Nacional Docente Madre - Nino San Bartolome ( Site 0057)
Lima, , Peru
Instituto de Investigacion Nutricional ( Site 0058)
Lima, , Peru
Clinica Peruano Americana S.A. ( Site 0061)
Trujillo, , Peru
Taichung Veterans General Hospital ( Site 0100)
Taichung, , Taiwan
National Taiwan University Hospital ( Site 0097)
Taipei, , Taiwan
Mackay Memorial Hospital ( Site 0099)
Taipei, , Taiwan
Chang Gung Medical Foundation. Linkou ( Site 0098)
Taoyuan District, , Taiwan
Chulalongkorn University ( Site 0102)
Bangkok, , Thailand
Siriraj Hospital ( Site 0101)
Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Hospital ( Site 0103)
Chiang Mai, , Thailand
Prince of Songkla University, Faculty of Medicine ( Site 0105)
Hat Yai, , Thailand
Srinagarind Hospital. Khon Kaen University ( Site 0104)
Khon Kaen, , Thailand
Countries
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References
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Banniettis N, Horn M, Sadarangani M, Patel SM, Greenberg D, Oberdorfer P, Klein NP, Rupp R, Dagan R, Richmond P, Lumley J, Zhou W, Shi Y, Tamms G, Feemster K, Lupinacci R, Musey L, Bickham K; V114-031 (PNEU-LINK) study group. Safety and Tolerability of V114 Pneumococcal Vaccine in Infants: A Phase 3 Study. Pediatrics. 2023 Jul 1;152(1):e2022060428. doi: 10.1542/peds.2022-060428.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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V114-031
Identifier Type: OTHER
Identifier Source: secondary_id
2018-003308-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
V114-031
Identifier Type: -
Identifier Source: org_study_id
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