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Vaccinations

Vaccinations

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Related Experiment Video

Updated: Apr 18, 2026

In Vitro ELISA Test to Evaluate Rabies Vaccine Potency

In Vitro ELISA Test to Evaluate Rabies Vaccine Potency

Published on: May 11, 2020

Two-part test of vaccine effect.

Zonghui Hu¹, Michael Proschan

¹Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, U.S.A.

Statistics in Medicine

|January 30, 2015

Summary

This study introduces two adaptive tests to evaluate vaccine effectiveness by assessing both disease prevention and severity reduction. These novel methods enhance statistical power for clinical trials analyzing treatment effects.

Keywords:

Fisher's exact test Lachenbruch's test local alternative randomization test vaccine

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Last Updated: Apr 18, 2026

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Area of Science:

Biostatistics
Clinical Trials
Vaccinology

Background:

Vaccine benefits encompass disease prevention and severity reduction.
Assessing dual vaccine benefits requires robust statistical methodologies.
Existing methods may not optimally leverage data on both incidence and severity.

Purpose of the Study:

To propose and evaluate two novel adaptive statistical tests for assessing vaccine efficacy.
To develop methods that can analyze both disease incidence (binary outcome) and severity (continuous outcome).
To enhance statistical power in clinical trials by incorporating information on both primary and secondary endpoints.

Main Methods:

Introduction of a weighted two-part test combining incidence and severity statistics.
Development of a randomized test for scenarios with limited infection counts, prioritizing incidence.
Asymptotic properties and numerical simulations used to explore test performance.
Weighting schemes determined by a priori effect sizes to maximize testing power.

Main Results:

The proposed adaptive tests demonstrate potential for increased power in vaccine efficacy evaluations.
The weighted two-part test effectively balances information from disease incidence and severity.
The randomized test offers a powerful approach for small sample sizes while focusing on disease incidence.

Conclusions:

The novel adaptive tests provide powerful tools for evaluating vaccine effects on both disease incidence and severity.
These methods are applicable beyond vaccine studies to any trial with binary and continuous outcomes.
The proposed statistical approaches can improve the efficiency and accuracy of treatment effect evaluations.