Introduction: Streptococcus pneumoniae is a major cause of infectious diseases, particularly in children under 5, leading to approximately 300,000 deaths annually. The introduction of pneumococcal conjugate vaccines (PCVs), such as PCV13, has significantly reduced invasive pneumococcal disease (IPD). However, rising cases of IPD caused by non-vaccine serotypes highlight the need for broader coverage vaccines like PCV15 (V114). This study aims to evaluate the immunogenicity and safety of V114 compared to PCV13 in healthy infants. Method(s): This systematic review and meta-analysis followed PRISMA guidelines and was registered with PROSPERO (CRD42024576730). Two reviewers searched MEDLINE, Google Scholar, and Cochrane databases for randomized controlled trials (RCTs) comparing V114 and PCV13 in infants. Data were extracted on immunogenicity (IgG response and geometric mean concentration) and safety outcomes. Meta-regression was conducted using R software for variables where heterogeneity could not be explained through subgroup analysis or leave-one-out analysis. Result(s): A total of 11 RCTs involving 9970 infants were included. Immunogenicity results indicated higher seropositivity for shared serotypes in PCV13, while V114 showed superior responses for unique serotypes (22F and 33F). No significant differences in overall adverse effects were observed between the two vaccines, although injection-site pain was more common with V114 and urticaria was noted more frequently with PCV13. Conclusion(s): V114 demonstrated enhanced immunogenicity for certain serotypes and comparable safety profiles to PCV13. The findings support the potential of V114 to address the limitations of current vaccines, particularly against non-vaccine serotypes. Further research is necessary to evaluate long-term immunity and real-world effectiveness. Copyright © 2025
Abstract
Newborn
Pneumococcal disease
Efficacy/effectiveness
Safety
Administration
