A phase 3, randomized study to evaluate the safety, tolerability, and immunogenicity of V116 in children and adolescents with increased risk of pneumococcal disease (STRIDE-13)
3
Issued Date
2026-01-01
Resource Type
ISSN
21645515
eISSN
2164554X
Scopus ID
2-s2.0-105043386207
Pubmed ID
42334402
Journal Title
Human Vaccines and Immunotherapeutics
Volume
22
Issue
1
Rights Holder(s)
SCOPUS
Bibliographic Citation
Human Vaccines and Immunotherapeutics Vol.22 No.1 (2026)
Suggested Citation
Jagannath V., Pathirana J., Perez Yepes C.A., Lopez-Medina E., Navarro J.A., Korbal P., Phongsamart W., Inui A., Kantele A., Atwi J.E., Tapiero B., Alabaz D., Baquero-Artigao F., Zeng T., Euler D., Papa M., Fernsler D., Park J., Esteves-Jaramillo A., Platt H.L. A phase 3, randomized study to evaluate the safety, tolerability, and immunogenicity of V116 in children and adolescents with increased risk of pneumococcal disease (STRIDE-13). Human Vaccines and Immunotherapeutics Vol.22 No.1 (2026). doi:10.1080/21645515.2026.2684089 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/117859
Title
A phase 3, randomized study to evaluate the safety, tolerability, and immunogenicity of V116 in children and adolescents with increased risk of pneumococcal disease (STRIDE-13)
Author's Affiliation
University of Montreal
Merck & Co., Inc.
Helsinki University Hospital
Hospital Universitario La Paz
Çukurova Üniversitesi
Siriraj Hospital
Universidad del Valle, Cali
Clinica Alemana
Saiseikai Yokohamashi Tobu Hospital
Ochsner Lafayette General Medical Center
Dr. Jan Biziel University Hospital
IMAT Oncomedica Clinic
Merck & Co., Inc.
Helsinki University Hospital
Hospital Universitario La Paz
Çukurova Üniversitesi
Siriraj Hospital
Universidad del Valle, Cali
Clinica Alemana
Saiseikai Yokohamashi Tobu Hospital
Ochsner Lafayette General Medical Center
Dr. Jan Biziel University Hospital
IMAT Oncomedica Clinic
Corresponding Author(s)
Other Contributor(s)
Abstract
Pneumococcal disease (PD) causes significant illness and death, especially in young children, older adults, and individuals with chronic medical conditions. Due to increased risk, children with chronic conditions are often advised to receive additional pneumococcal vaccination beyond the routine primary series. This phase 3 study evaluated the safety and immunogenicity of V116, a 21-valent pneumococcal conjugate vaccine, compared to PPSV23 in children aged 2 to <18 y with certain medical conditions that increase risk of PD who had previously completed a primary pneumococcal vaccination regimen. Individuals with diabetes mellitus, chronic heart, chronic lung, chronic kidney, and/or chronic liver disease were randomized 3:2 to receive a single dose of either V116 (n = 531) or PPSV23 (n = 351). Immunogenicity was assessed at 30 d postvaccination comparing opsonophagocytic activity (OPA) geometric mean titers (GMTs) and immunoglobulin G (IgG) geometric mean concentrations (GMCs) between groups. Safety was evaluated by the proportion of participants with adverse events (AEs). The V116 group met the statistical noninferiority criterion for each of the 12 pneumococcal vaccine serotypes shared between V116 and PPSV23 and additionally met superiority criterion for each of the 9 serotypes unique to V116 based on OPA GMTs. IgG GMCs were consistent with the OPA results. The safety profile was generally comparable between groups. In children and adolescents aged 2 to <18 y with certain medical conditions, V116 is well tolerated and immunogenic. These findings support the use of V116 to broaden pneumococcal serotype coverage in populations at increased risk of pneumococcal disease.