LLOQ and LOD – Clinical Research Made Simple

Using Seroconversion as an Endpoint in Vaccine Trials

August 5, 2025

Using Seroconversion as an Endpoint in Vaccine Trials Seroconversion as a Vaccine Trial Endpoint: A Practical, Regulatory-Ready Guide What “Seroconversion” Means in Practice—and When It’s the Right Endpoint “Seroconversion” (SCR) translates immunology into a binary decision: did a participant mount a meaningful antibody response or not? In vaccine trials, it’s typically defined as a ≥4-fold…

Immunogenicity Assessments, Vaccine Clinical Trials

Phase I Vaccine Trials: Safety and Dosage Exploration

August 1, 2025

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Phase I Vaccine Trials: Safety and Dosage Exploration How Phase I Vaccine Trials Establish Safety and Select Doses What Phase I Vaccine Trials Aim to Prove (and What They Don’t) Phase I vaccine trials are the first time a candidate is administered to humans, typically 20–100 healthy adults. The objectives are intentionally narrow: characterize initial…

Phase I–IV Vaccine Trials, Vaccine Clinical Trials