Estimand for non-inferiority influenza vaccine immunogenicity trials

Author:

Nauta JozefORCID

Publisher

Elsevier BV

Subject

Infectious Diseases,Public Health, Environmental and Occupational Health,General Veterinary,General Immunology and Microbiology,Molecular Medicine

Reference7 articles.

1. International Council for Harmonisation. ICH Harmonised Tripartite Guideline Statistical Principles for Clinical Trials E9. Published February 5, 1998; 2023. [accessed 28 December 2023].

2. International Council for Harmonisation. ICH harmonised guideline addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials. E9(R1) Published February 17, 2020; 2023. [accessed 28 December 2023].

3. Immunogenicity and safety of an egg culture-based quadrivalent inactivated non-adjuvanted subunit influenza vaccine in subjects ≥3 years: a randomized, multicenter, double-blind, active-controlled phase III, non-inferiority trial;Zhang;Vaccine,2022

4. Safety and immunogenicity of a quadrivalent, inactivated, split-virion influenza vaccine (IIV4-W) in healthy people aged 3–60 years: a phase III randomized clinical noninferiority trial;Huang;Human Vaccin Immunother,2022

5. Safety and immunogenicity of cell-based quadrivalent influenza vaccine: a randomized trial;Essink;Pediatrics,2022

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