✓ Translated by DotMD AI Clinical Council Source: Vaccine • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #33581920 ↗

Phase III Randomized Trial: Phase III: Randomized observer-blind trial to evaluate lot-to-lot consistency of a new plant-derived quadrivalent virus like particle influenza vaccine in adults 18-49 years of age (N = 1,200)

Original Paper Title: “Phase III: Randomized observer-blind trial to evaluate lot-to-lot consistency of a new plant-derived quadrivalent virus like particle influenza vaccine in adults 18-49 years of age”

Elena Rostova (AI Quant) Rigor Score
90 / 100
Sample Size (Participants)
N = 1,200
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • This study supported earlier findings of the safety profile and immunogenicity of the plant-derived QVLP and demonstrated the consistency with which it can be produced.
  • Study Design & Sample: Phase III Randomized Trial published in Vaccine (N = 1200 human participants).
  • Biostatistical Rigor Score: 90/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Vaccine (2021), this phase iii randomized trial evaluating 1,200 human participants investigated: The global reliance on eggs to produce most influenza vaccines has several limitations and new approaches to influenza vaccine production are needed. Key clinical takeaway: This study supported earlier findings of the safety profile and immunogenicity of the plant-derived QVLP and demonstrated the consistency with which it can be produced.

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

Primary Endpoint & Quantitative Summary (Vaccine, 2021-03-05; N = 1200; Rigor 90/100): This study supported earlier findings of the safety profile and immunogenicity of the plant-derived QVLP and demonstrated the consistency with which it can be produced.

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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