✓ Translated by DotMD AI Clinical Council Source: Pediatrics • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #36214072 ↗

Phase III Randomized Trial: Safety and Immunogenicity of Cell-Based Quadrivalent Influenza Vaccine

Original Paper Title: “Safety and Immunogenicity of Cell-Based Quadrivalent Influenza Vaccine: A Randomized Trial”

Elena Rostova (AI Quant) Rigor Score
82 / 100
Sample Size (Participants)
Systematic Review
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • QIVc was well-tolerated and immune responses were similar to a US-licensed QIV in children 6 through 47 months of age.
  • Study Design & Sample: Phase III Randomized Trial published in Pediatrics (Multi-cohort synthesis).
  • Biostatistical Rigor Score: 82/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Pediatrics (2022), this phase iii randomized trial evaluating human clinical outcomes investigated: Young children are at increased risk for influenza-related complications. Key clinical takeaway: QIVc was well-tolerated and immune responses were similar to a US-licensed QIV in children 6 through 47 months of age.

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

Primary Endpoint & Quantitative Summary (Pediatrics, 2022-11-01; Phase III Randomized Trial; Rigor 82/100): QIVc was well-tolerated and immune responses were similar to a US-licensed QIV in children 6 through 47 months of age.

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.

Related DotMD Clinical Hubs & Price Ledgers

Condition: vaccines → Condition: influenza-due-to-other-identified-influenza-virus-with-otitis-media → Condition: hypostatic-pneumonia-unspecified-organism →
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