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)
ABSTRACTThere is an ongoing burden of pneumococcal disease in children despite the use of pneumococcal conjugate vaccines (PCVs). This phase 3, open-label, single-arm, multisite, descriptive study was designed to evaluate the safety and immunogenicity of a 3 + 1 regimen of V114 (VAXNEUVANCE™), a 15-...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2024-12-01
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| Series: | Human Vaccines & Immunotherapeutics |
| Subjects: | |
| Online Access: | https://www.tandfonline.com/doi/10.1080/21645515.2024.2321035 |
| _version_ | 1827315294890098688 |
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| author | Alvino Maestri Su Eun Park Fiona Fernandes Zhongyi “Lucy” Li Yae-Jean Kim Yun-Kyung Kim Jin Lee Ji Young Park Dong Hyun Kim GyongSeon Yang Hyunjung Lim Jin Oh Kim Robert Lupinacci Tina M. Sterling Marissa Wilck Alejandra Esteves-Jaramillo Natalie Banniettis |
| author_facet | Alvino Maestri Su Eun Park Fiona Fernandes Zhongyi “Lucy” Li Yae-Jean Kim Yun-Kyung Kim Jin Lee Ji Young Park Dong Hyun Kim GyongSeon Yang Hyunjung Lim Jin Oh Kim Robert Lupinacci Tina M. Sterling Marissa Wilck Alejandra Esteves-Jaramillo Natalie Banniettis |
| author_sort | Alvino Maestri |
| collection | DOAJ |
| description | ABSTRACTThere is an ongoing burden of pneumococcal disease in children despite the use of pneumococcal conjugate vaccines (PCVs). This phase 3, open-label, single-arm, multisite, descriptive study was designed to evaluate the safety and immunogenicity of a 3 + 1 regimen of V114 (VAXNEUVANCE™), a 15-valent PCV, in South Korean infants and toddlers. Adverse events (AEs) were reported for 14 d following any vaccination, and throughout the study period for serious AEs. Serotype-specific immunoglobulin G (IgG) response rates (proportion of participants meeting an IgG threshold value of ≥0.35 μg/mL) and geometric mean concentrations (GMCs) for the 15 serotypes at 30 d postdose 3 (PD3) and at 30 d postdose 4 (PD4) were evaluated as endpoints. Healthy infants enrolled at 42–90 d after birth were vaccinated with V114 (N = 57). The most commonly reported AEs were those solicited in the trial. The majority of reported AEs were transient and of mild or moderate intensity. Few serious AEs were reported; none were vaccine related. No participants died nor discontinued the study vaccine because of an AE. V114 was immunogenic for all 15 serotypes contained in the vaccine, as assessed by IgG response rates at 30 d PD3 and IgG GMCs at 30 d PD3 and at 30 d PD4. V114 was well tolerated and immunogenic when administered as a 3 + 1 regimen in healthy South Korean infants and toddlers. |
| first_indexed | 2024-04-24T22:51:42Z |
| format | Article |
| id | doaj.art-bee75b52b4b44c919cf78d85f82b27ea |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-04-24T22:51:42Z |
| publishDate | 2024-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-bee75b52b4b44c919cf78d85f82b27ea2024-03-18T11:00:28ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2024-12-0120110.1080/21645515.2024.2321035A 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)Alvino Maestri0Su Eun Park1Fiona Fernandes2Zhongyi “Lucy” Li3Yae-Jean Kim4Yun-Kyung Kim5Jin Lee6Ji Young Park7Dong Hyun Kim8GyongSeon Yang9Hyunjung Lim10Jin Oh Kim11Robert Lupinacci12Tina M. Sterling13Marissa Wilck14Alejandra Esteves-Jaramillo15Natalie Banniettis16MRL, Merck & Co., Inc., Rahway, NJ, USADepartment of Pediatrics, Pusan National University Children’s Hospital, Yangsan, Republic of KoreaMRL, Merck & Co., Inc., Rahway, NJ, USAMRL, Merck & Co., Inc., Rahway, NJ, USADepartment of Pediatrics, Sungkyunkwan University School of Medicine, Samsung Medical Centre, Seoul, Republic of KoreaDepartment of Pediatrics, Korea University College of Medicine, Seoul, Republic of KoreaDepartment of Pediatrics, Incheon St. Mary’s Hospital, Incheon, Republic of KoreaDepartment of Pediatrics, Chung-Ang University Hospital, Seoul, Republic of KoreaDepartment of Pediatrics, Inha University Hospital, Incheon, Republic of KoreaGlobal Medical Scientific Affairs, MSD Korea, Seoul, Republic of KoreaGlobal Clinical Trial Operations, MSD Korea, Seoul, Republic of KoreaGlobal Medical Scientific Affairs, MSD Korea, Seoul, Republic of KoreaMRL, Merck & Co., Inc., Rahway, NJ, USAMRL, Merck & Co., Inc., Rahway, NJ, USAMRL, Merck & Co., Inc., Rahway, NJ, USAMRL, Merck & Co., Inc., Rahway, NJ, USAMRL, Merck & Co., Inc., Rahway, NJ, USAABSTRACTThere is an ongoing burden of pneumococcal disease in children despite the use of pneumococcal conjugate vaccines (PCVs). This phase 3, open-label, single-arm, multisite, descriptive study was designed to evaluate the safety and immunogenicity of a 3 + 1 regimen of V114 (VAXNEUVANCE™), a 15-valent PCV, in South Korean infants and toddlers. Adverse events (AEs) were reported for 14 d following any vaccination, and throughout the study period for serious AEs. Serotype-specific immunoglobulin G (IgG) response rates (proportion of participants meeting an IgG threshold value of ≥0.35 μg/mL) and geometric mean concentrations (GMCs) for the 15 serotypes at 30 d postdose 3 (PD3) and at 30 d postdose 4 (PD4) were evaluated as endpoints. Healthy infants enrolled at 42–90 d after birth were vaccinated with V114 (N = 57). The most commonly reported AEs were those solicited in the trial. The majority of reported AEs were transient and of mild or moderate intensity. Few serious AEs were reported; none were vaccine related. No participants died nor discontinued the study vaccine because of an AE. V114 was immunogenic for all 15 serotypes contained in the vaccine, as assessed by IgG response rates at 30 d PD3 and IgG GMCs at 30 d PD3 and at 30 d PD4. V114 was well tolerated and immunogenic when administered as a 3 + 1 regimen in healthy South Korean infants and toddlers.https://www.tandfonline.com/doi/10.1080/21645515.2024.2321035Vaxneuvance™PCV15pneumococcal conjugate vaccineinfantstoddlers |
| spellingShingle | Alvino Maestri Su Eun Park Fiona Fernandes Zhongyi “Lucy” Li Yae-Jean Kim Yun-Kyung Kim Jin Lee Ji Young Park Dong Hyun Kim GyongSeon Yang Hyunjung Lim Jin Oh Kim Robert Lupinacci Tina M. Sterling Marissa Wilck Alejandra Esteves-Jaramillo Natalie Banniettis 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) Human Vaccines & Immunotherapeutics Vaxneuvance™ PCV15 pneumococcal conjugate vaccine infants toddlers |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| topic | Vaxneuvance™ PCV15 pneumococcal conjugate vaccine infants toddlers |
| url | https://www.tandfonline.com/doi/10.1080/21645515.2024.2321035 |
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