✓ Translated by DotMD AI Clinical Council Source: Vaccine • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #40763490 ↗

Phase III Randomized Trial: A phase 3 randomized trial (STRIDE-9) to evaluate the safety, tolerability, and immunogenicity of V116, a population-specific pneumococcal conjugate vaccine, in pneumococcal vaccine-naïve Japanese adults ≥65 years of age

Original Paper Title: “A phase 3 randomized trial (STRIDE-9) to evaluate the safety, tolerability, and immunogenicity of V116, a population-specific pneumococcal conjugate vaccine, in pneumococcal vaccine-naïve Japanese adults ≥65 years of age”

Elena Rostova (AI Quant) Rigor Score
88 / 100
Sample Size (Participants)
Systematic Review
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • In vaccine-naïve Japanese adults ≥65 years of age, V116 is well tolerated, with a safety profile comparable to PPSV23, and elicits immune responses to all V116 serotypes and the cross-reactive serotype 15B.
  • Study Design & Sample: Phase III Randomized Trial published in Vaccine (Multi-cohort synthesis).
  • Biostatistical Rigor Score: 88/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Vaccine (2025), this phase iii randomized trial evaluating human clinical outcomes investigated: Pneumococcal disease (PD) prevention remains an unmet medical need in older adults. Key clinical takeaway: In vaccine-naïve Japanese adults ≥65 years of age, V116 is well tolerated, with a safety profile comparable to PPSV23, and elicits immune responses to all V116 serotypes and the cross-reactive serotype 15B.

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (Vaccine, 2025-08-30; Phase III Randomized Trial; Rigor 88/100): In vaccine-naïve Japanese adults ≥65 years of age, V116 is well tolerated, with a safety profile comparable to PPSV23, and elicits immune responses to all V116 serotypes and the cross-reactive serotype 15B.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

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Condition: pneumococcal-infections → Condition: vaccines →
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