Comparison of three sample size calculation methods for non-inferiority vaccine trials with multiple continuous co-primary endpoints-Reference-Cited by-同舟云学术

Comparison of three sample size calculation methods for non-inferiority vaccine trials with multiple continuous co-primary endpoints

Published:2018-10-04 Issue:1 Volume:15 Page:256-263
ISSN:2164-5515
Container-title:Human Vaccines & Immunotherapeutics
language:en
Short-container-title:Human Vaccines & Immunotherapeutics

Author:

Yang Jiaying¹,Li Jingxin²,Wang Shiyuan¹,Luo Li¹,Liu Pei¹^ORCID

Affiliation:

1. Department of Epidemiology and Biostatistics, Southeast University, Nanjing, China

2. Jiangsu Province Center for Disease Control and Prevention, Nanjing, China

Funder

Postgraduate Research * Practice Innovation Program of Jiangsu Province

the Fundamental Research Funds for the Central Universities and Postgraduate Research Practice Innovation Program of Jiangsu Province

Publisher

Informa UK Limited

Subject

Pharmacology,Immunology,Immunology and Allergy

Link

https://www.tandfonline.com/doi/pdf/10.1080/21645515.2018.1514221

Reference35 articles.

1. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research. Guidance for industry for the evaluation of combination vaccines for preventable diseases: production, testing and clinical studies. 1997 April accessed 2017 Oct 21. https://wwwfdagov/downloads/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/vaccines/ucm175909pdf 1997.

2. Elsevier, Inc. “polyvalent vaccine”. Saunders comprehensive veterinary dictionary, 3 ed. 2007 accessed 2017 Nov. https://medical-dictionary.thefreedictionary.com/polyvalent+vaccine.

3. Multiparameter Hypothesis Testing and Acceptance Sampling

4. Challenge of multiple co-primary endpoints: a new approach

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