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)

ABSTRACT

There 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.

KE Y POINTS

Despite the use of pneumococcal vaccines, the burden of pneumococcal disease in children persists. V114, a 15-valent pneumococcal conjugate vaccine, was immunogenic and well-tolerated in healthy South Korean infants and toddlers.

KEYWORDS:

• Vaxneuvance™
• PCV15
• pneumococcal conjugate vaccine
• infants
• toddlers

Acknowledgments

The authors would like to thank the patients, their families, and all investigators involved in this study. Medical writing support, including assisting authors with the development of the outline and initial draft and incorporation of comments, was provided by Martina Kusi-Mensah, PharmD, of Scion, London, and editorial support, including fact checking, referencing, figure preparation, formatting, proofreading, and submission was provided by Ian Norton, PhD, of Scion, London, UK, according to Good Publication Practice 2022 guidelines (Link). This assistance was funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Disclosure statement

Fiona Fernandes is an ex-employee of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA and may own stock and/or stock options in Merck & Co., Inc., Rahway, NJ, USA. Jin Oh Kim, GyongSeon Yang, and Hyunjung Lim are employees of MSD Korea and may own stock and/or stock options in Merck & Co., Inc., Rahway, NJ, USA. Jin Lee, Ji Young Park, Su Eun Park, Yun-Kyung Kim, and Dong Hyun Kim have no conflicts to disclose at this time. Yae-Jean Kim is an employee of MSD Korea and may have received funding for this research, provision of study materials, and article processing charges from Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. All other authors are employees of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA and may own stock and/or stock options in Merck & Co., Inc., Rahway, NJ, USA.

Author contributions

Alvino Maestri was involved in the acquisition of data, drafting of manuscript, interpretation of results, and critically reviewing or revising the manuscript.

Su Eun Park was involved in the acquisition of data and critically reviewing or revising the manuscript.

Fiona Fernandes was involved in the conception, design, or planning of the study, acquisition of data, and drafting of the manuscript.

Zhongyi “Lucy” Li was involved in the conception, design, or planning of the study, acquisition of data, analysis of data, interpretation of results, drafting manuscript, and critically reviewing or revising the manuscript.

Yae Jean Kim was involved in the acquisition of data, and critically reviewing or revising the manuscript.

Yun-Kyung Kim was involved in the acquisition of data and interpretation of results.

Jin Lee was involved in the acquisition of data, analysis of data, interpretation of results, and critically reviewing or revising the manuscript.

Ji Young Park was involved in the acquisition of data and analysis of data.

Dong Hyun Kim was involved in the acquisition of data, and critically reviewing or revising the manuscript.

GyongSeon Yang was involved in the conception, design, or planning of the study, and critically reviewing or revising the manuscript.

Hyunjung Lim was involved in the acquisition of data, analysis of data, and critically reviewing or revising the manuscript.

Jin Oh Kim was involved in the conception, design, or planning of the study, analysis of data, interpretation of results, and critically reviewing or revising the manuscript.

Robert Lupinacci was involved in the conception, design, or planning of the study, analysis of data, and interpretation of results.

Tina M. Sterling was involved in the interpretation of results, and critically reviewing or revising the manuscript.

Marissa Wilck was involved in the conception, design, or planning of the study, and critically reviewing or revising the manuscript.

Alejandra Esteves-Jaramillo was involved in the acquisition of data, interpretation of results, drafting manuscript, and critically reviewing or revising the manuscript.

Natalie Banniettis was involved in analysis of data, and critically reviewing or revising the manuscript.

Data sharing

The data sharing policy, including restrictions, of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA is available at http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html).

Supplementary material

Supplemental data for this article can be accessed on the publisher’s website at https://doi.org/10.1080/21645515.2024.2321035.

Additional information

Funding

This study was supported by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.