TY - JOUR
T1 - A phase III, multicenter, randomized, double-blind, active comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of catch-up vaccination regimens of V114, a 15-valent pneumococcal conjugate vaccine, in healthy infants, children, and adolescents (PNEU-PLAN)
AU - Banniettis, Natalie
AU - Wysocki, Jacek
AU - Szenborn, Leszek
AU - Phongsamart, Wanatpreeya
AU - Pitisuttithum, Punnee
AU - Rämet, Mika
AU - Richmond, Peter
AU - Shi, Yaru
AU - Dagan, Ron
AU - Good, Lori
AU - Papa, Melanie
AU - Lupinacci, Robert
AU - McFetridge, Richard
AU - Tamms, Gretchen
AU - Churchill, Clay
AU - Musey, Luwy
AU - Bickham, Kara
N1 - Funding Information:
NB, YS, LG, MP, RL, GT, and CC are employees of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (MSD), and may own stock and/or stock options in Merck & Co., Inc., Rahway, NJ, USA. LM and KB are former employees of MSD and own stock and/or stock options in Merck & Co., Inc., Rahway, NJ, USA. RM was an employee of MSD at the time the study was conducted. JW and LS have taken part in clinical vaccine trials, served on advisory boards, and presented satellite symposia during medical congresses for GlaxoSmithKline, Pfizer, and MSD. For MR, Tampere University Vaccine Research Center carries out clinical vaccine trials for most major vaccine manufacturers, including MSD. PR has taken part in clinical vaccine trials and served on advisory boards for GlaxoSmithKline, Pfizer, and MSD. RD has received grants from Pfizer, MSD, and MedImmune/AstraZeneca. He serves scientific consultant, on the review/board/advisory committee of Pfizer and MSD. He is also part of the speakers’ bureaus of Pfizer, MSD, Sanofi Pasteur, and GlaxoSmithKline. All other authors report no potential conflicts of interest. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest.
Funding Information:
We thank each of the participants, study staff, and investigators in the V114-024 (PNEU-PLAN) study group for their invaluable contributions to this study. Medical writing and/or editorial assistance was provided by Cindy Cheung, MBBS (MD) and Ian Norton, PhD, both of Scion, London. This assistance was funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. A full list of investigators for this study can be found in Supplemental Table 16 .
Funding Information:
We thank each of the participants, study staff, and investigators in the V114-024 (PNEU-PLAN) study group for their invaluable contributions to this study. Medical writing and/or editorial assistance was provided by Cindy Cheung, MBBS (MD) and Ian Norton, PhD, both of Scion, London. This assistance was funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co. Inc. Rahway, NJ, USA. A full list of investigators for this study can be found in Supplemental Table 16. NB, YS, LG, MP, RL, GT, and CC are employees of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co. Inc. Rahway, NJ, USA (MSD), and may own stock and/or stock options in Merck & Co. Inc. Rahway, NJ, USA. LM and KB are former employees of MSD and own stock and/or stock options in Merck & Co. Inc. Rahway, NJ, USA. RM was an employee of MSD at the time the study was conducted. JW and LS have taken part in clinical vaccine trials, served on advisory boards, and presented satellite symposia during medical congresses for GlaxoSmithKline, Pfizer, and MSD. For MR, Tampere University Vaccine Research Center carries out clinical vaccine trials for most major vaccine manufacturers, including MSD. PR has taken part in clinical vaccine trials and served on advisory boards for GlaxoSmithKline, Pfizer, and MSD. RD has received grants from Pfizer, MSD, and MedImmune/AstraZeneca. He serves scientific consultant, on the review/board/advisory committee of Pfizer and MSD. He is also part of the speakers’ bureaus of Pfizer, MSD, Sanofi Pasteur, and GlaxoSmithKline. All other authors report no potential conflicts of interest. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Funding for this research was provided by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co. Inc. Rahway, NJ, USA. Banniettis N: conception, design or planning of the study; analysis of the data; interpretation of the results; drafting of the manuscript; review of the manuscript. Wysocki J, Szenborn L: acquisition of the data; review of the manuscript. Phongsamart W, Pitisuttithum P, Rämet M: acquisition of the data; interpretation of the results; review of the manuscript. Richmond P: interpretation of the results; review of the manuscript. Dagan R: interpretation of the results; drafting of the manuscript; review of the manuscript. Good L: conception, design or planning of the study; review of the manuscript. Papa M, Churchill C: conception, design or planning of the study; acquisition of the data; review of the manuscript. Lupinacci R; Bickham K: conception, design or planning of the study; analysis of the data; interpretation of the results; review of the manuscript. Shi Y, Musey L: conception, design or planning of the study; acquisition of the data; analysis of the data; interpretation of the results; drafting of the manuscript; review of the manuscript. All authors provided final approval of the version to be published. All authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The data sharing policy, including restrictions, of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co. Inc. Rahway, NJ, USA is available at http://engagezone.msd.com/ds_documentation.php. Requests for access to the clinical study data can be submitted through the Engage Zone site or via email to [email protected].
Publisher Copyright:
© 2022 The Authors
PY - 2022/10/19
Y1 - 2022/10/19
N2 - Background: Despite widespread use of pneumococcal conjugate vaccines (PCVs) in children, morbidity and mortality caused by pneumococcal disease (PD) remain high. In addition, many children do not complete their PCV course on schedule. V114 is a 15-valent PCV that contains two epidemiologically important serotypes, 22F and 33F, in addition to the 13 serotypes present in PCV13, the licensed 13-valent PCV. Methods: This phase III descriptive study evaluated safety and immunogenicity of catch-up vaccination with V114 or PCV13 in healthy children 7 months–17 years of age who were either pneumococcal vaccine-naïve or previously immunized with lower valency PCVs (NCT03885934). Overall, 606 healthy children were randomized to receive V114 (n = 303) or PCV13 (n = 303) via age-appropriate catch-up vaccination schedules in three age cohorts (7–11 months, 12–23 months, or 2–17 years). Results: Similar proportions of children 7–11 months and 2–17 years of age reported adverse events (AEs) in the V114 and PCV13 groups. A numerically greater proportion of children 12–23 months of age reported AEs in the V114 group (79.0%) than the PCV13 group (59.4%). The proportions of children who reported serious AEs varied between different age cohorts but were generally comparable between vaccination groups. No vaccine-related serious AEs were reported, and no deaths occurred. At 30 days after the last PCV dose, serotype-specific immunoglobulin G geometric mean concentrations were comparable between vaccination groups for the 13 shared serotypes and higher in the V114 group for 22F and 33F. Conclusions: Catch-up vaccination with V114 in healthy individuals 7 months–17 years of age was generally well tolerated and immunogenic for all 15 serotypes, including those not contained in PCV13, regardless of prior pneumococcal vaccination. These results support V114 catch-up vaccination in children with incomplete or no PCV immunization per the recommended schedule.
AB - Background: Despite widespread use of pneumococcal conjugate vaccines (PCVs) in children, morbidity and mortality caused by pneumococcal disease (PD) remain high. In addition, many children do not complete their PCV course on schedule. V114 is a 15-valent PCV that contains two epidemiologically important serotypes, 22F and 33F, in addition to the 13 serotypes present in PCV13, the licensed 13-valent PCV. Methods: This phase III descriptive study evaluated safety and immunogenicity of catch-up vaccination with V114 or PCV13 in healthy children 7 months–17 years of age who were either pneumococcal vaccine-naïve or previously immunized with lower valency PCVs (NCT03885934). Overall, 606 healthy children were randomized to receive V114 (n = 303) or PCV13 (n = 303) via age-appropriate catch-up vaccination schedules in three age cohorts (7–11 months, 12–23 months, or 2–17 years). Results: Similar proportions of children 7–11 months and 2–17 years of age reported adverse events (AEs) in the V114 and PCV13 groups. A numerically greater proportion of children 12–23 months of age reported AEs in the V114 group (79.0%) than the PCV13 group (59.4%). The proportions of children who reported serious AEs varied between different age cohorts but were generally comparable between vaccination groups. No vaccine-related serious AEs were reported, and no deaths occurred. At 30 days after the last PCV dose, serotype-specific immunoglobulin G geometric mean concentrations were comparable between vaccination groups for the 13 shared serotypes and higher in the V114 group for 22F and 33F. Conclusions: Catch-up vaccination with V114 in healthy individuals 7 months–17 years of age was generally well tolerated and immunogenic for all 15 serotypes, including those not contained in PCV13, regardless of prior pneumococcal vaccination. These results support V114 catch-up vaccination in children with incomplete or no PCV immunization per the recommended schedule.
KW - Catch-up vaccination
KW - Immunogenicity
KW - Pneumococcal conjugate vaccine
KW - Pneumococcal disease
KW - Safety
U2 - 10.1016/j.vaccine.2022.09.003
DO - 10.1016/j.vaccine.2022.09.003
M3 - Article
C2 - 36150974
AN - SCOPUS:85138564402
SN - 0264-410X
VL - 40
SP - 6315
EP - 6325
JO - VACCINE
JF - VACCINE
IS - 44
ER -
