Estimand for non-inferiority influenza vaccine immunogenicity trials

Author:

Nauta JozefORCID

Publisher

Elsevier BV

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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