Peer-reviewed article
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).
Vinita Jagannath, Jayani Pathirana, Carlos Alberto Perez Yepes, Eduardo Lopez-Medina, Juan Andres Navarro et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This study tested a new 21-valent pneumococcal vaccine (V116) in children and adolescents aged 2 to 18 years with chronic medical conditions that increase their risk of pneumococcal disease. The vaccine was compared to an existing vaccine (PPSV23) in a randomized trial with over 880 participants. V116 produced stronger immune responses against all pneumococcal types tested and had a similar safety profile to the comparison vaccine, suggesting it could provide better protection for vulnerable children.
Key points
- V116 met non-inferiority criteria for 12 pneumococcal serotypes shared with PPSV23
- V116 met superiority criteria for 9 serotypes unique to V116 based on immune response measures
- Safety profile was generally comparable between V116 and PPSV23 groups
- Study included children with diabetes, chronic heart, lung, kidney, and/or liver disease
- Immunogenicity was assessed at 30 days post-vaccination using opsonophagocytic activity and immunoglobulin G measures
Limitations
The study does not report long-term protection or clinical effectiveness in preventing actual disease; it only measures laboratory markers of immune response. The document does not specify which countries participated or provide detailed safety data breakdowns.
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.
Findings the Hub has extracted
Each claim below is labelled by its type of design and links back to this report.
- Intervention
- Single dose of V116 (21-valent pneumococcal conjugate vaccine) compared to PPSV23 in children aged 2 to <18 years with chronic conditions who had completed primary pneumococcal vaccination
- Population
- 882 children and adolescents aged 2 to <18 years with diabetes mellitus, chronic heart disease, chronic lung disease, chronic kidney disease, and/or chronic liver disease who had previously completed a primary pneumococcal vaccination regimen
Key finding
V116 met non-inferiority for 12 shared pneumococcal serotypes and superiority for 9 unique serotypes based on opsonophagocytic activity geometric mean titers