Safety and Immunogenicity of V114 in Healthy Infants in South Korea (V114-036)
NCT ID: NCT04633226
Last Updated: 2024-09-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
58 participants
INTERVENTIONAL
2021-02-10
2022-11-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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V114
Participants received 4 total doses of V114, administered at approximately 2, 4, 6, and 12 to 15 months of age.
V114
15-valent pneumococcal conjugate vaccine (PCV) containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) present in Prevnar 13™ plus 2 additional serotypes (22F, 33F) in each 0.5 mL sterile suspension for intramuscular injection.
Interventions
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V114
15-valent pneumococcal conjugate vaccine (PCV) containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) present in Prevnar 13™ plus 2 additional serotypes (22F, 33F) in each 0.5 mL sterile suspension for intramuscular injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* has a parent or legally acceptable representative who understands study procedures, alternative treatments available, and risks involved and voluntarily agrees to participate by signing informed consent
Exclusion Criteria
* has known hypersensitivity to pneumococcal conjugate vaccine, any licensed pediatric vaccine to be administered concomitantly, or any diphtheria toxoid-containing vaccine
* has had a recent febrile illness (rectal temperature ≥38.1°C \[≥100.5°F\] or axillary temperature ≥37.8°C \[≥100.0°F\]) within 72 hours prior to receipt of study vaccine
* has known or suspected impairment of immunological function
* has or his/her mother has human immunodeficiency virus (HIV) infection
* has or his/her mother has hepatitis B surface antigen-positive test
* has known or history of functional or anatomic asplenia
* has a history of autoimmune disease
* has a history or suspected history of neurological disorder
* has received a pneumococcal vaccine prior to study entry
* has received, or is anticipated to need, corticosteroid therapy
* has received a blood transfusion of immunoglobulin products
* has participated in another clinical study of an investigational product
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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Jeonbuk National University Hospital ( Site 0008)
Jeonju, Jeonrabugdo, South Korea
Korea University Ansan Hospital ( Site 0006)
Ansan-si, Kyonggi-do, South Korea
Hallym University Sacred Heart Hospital ( Site 0011)
Anyang-si, Kyonggi-do, South Korea
Hallym University Dongtan Sacred Heart Hospital ( Site 0013)
Hwaseong-si, Kyonggi-do, South Korea
CHA Bundang Medical Center CHA University ( Site 0020)
Seongnam-si, Kyonggi-do, South Korea
Changwon Fatima Hospital ( Site 0015)
Changwon, Kyongsangnam-do, South Korea
Pusan National University Yangsan Hospital ( Site 0009)
Yangsan, Kyongsangnam-do, South Korea
Kyungpook National University Hospital ( Site 0014)
Daegu, Taegu-Kwangyokshi, South Korea
The Catholic University of Korea, Incheon St. Mary's Hospital ( Site 0012)
Incheon, , South Korea
Gachon University Gil Medical Center ( Site 0019)
Incheon, , South Korea
Inha University Hospital ( Site 0001)
Incheon, , South Korea
Korea Cancer Center Hospital ( Site 0017)
Seoul, , South Korea
Nowon Eulji Medical Center, Eulji University ( Site 0005)
Seoul, , South Korea
Severance Hospital Yonsei University Health System ( Site 0002)
Seoul, , South Korea
Samsung Medical Center ( Site 0007)
Seoul, , South Korea
The Catholic University of Korea ( Site 0003)
Seoul, , South Korea
Chung-Ang University Hospital ( Site 0016)
Seoul, , South Korea
Ewha Womans University Seoul Hospital ( Site 0010)
Seoul, , South Korea
Korea University Guro Hospital ( Site 0021)
Seoul, , South Korea
Countries
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References
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Maestri A, Park SE, Fernandes F, Li ZL, Kim YJ, Kim YK, Lee J, Park JY, Kim DH, Yang G, Lim H, Kim JO, Lupinacci R, Sterling TM, Wilck M, Esteves-Jaramillo A, Banniettis N. A phase 3, single-arm, open-label study to evaluate the safety, tolerability, and immunogenicity of a 15-valent pneumococcal conjugate vaccine, V114, in a 3+1 regimen in healthy infants in South Korea (PNEU-PED-KOR). Hum Vaccin Immunother. 2024 Dec 31;20(1):2321035. doi: 10.1080/21645515.2024.2321035. Epub 2024 Mar 18.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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V114-036
Identifier Type: OTHER
Identifier Source: secondary_id
2020-003181-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
V114-036
Identifier Type: -
Identifier Source: org_study_id
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