Harmonizing the collection of solicited adverse events in prophylactic vaccine clinical trials-Reference-Cited by-同舟云学术

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Harmonizing the collection of solicited adverse events in prophylactic vaccine clinical trials

Published:2023-10-09 Issue:1 Volume:22 Page:849-859
ISSN:1476-0584
Container-title:Expert Review of Vaccines
language:en
Short-container-title:Expert Review of Vaccines

Author:

Cheuvart Brigitte¹^ORCID,Spiessens Bart²,van Heesbeen Roy³,Hung Derchieh⁴,Andrade Coralie⁴,Korejwo-Peyramond Joanna⁵,Tavares-Da-Silva Fernanda¹⁶^ORCID

Affiliation:

1. Clinical Research and Development, GSK, Wavre, Belgium

2. Statistics and Decision Sciences, Janssen Research & Development, Beerse, Belgium

3. Clinical Development, Janssen Vaccines & Prevention, Leiden, Netherlands

4. Clinical Development, Seqirus, Melbourne, Australia

5. Patient Safety & Pharmacovigilance, Sanofi, Lyon, France

6. Global Pharmacovigilance and Safety Science department, Organon, Brussels, Belgium

Funder

GlaxoSmithKline Biologicals SA

Publisher

Informa UK Limited

Subject

Drug Discovery,Pharmacology,Molecular Medicine,Immunology

Link

https://www.tandfonline.com/doi/pdf/10.1080/14760584.2023.2262571

Reference29 articles.

1. The how’s and what’s of vaccine reactogenicity

2. Current Practices, Challenges, and Statistical Issues With Product Safety Labeling

3. CBER. Emergency use authorization for vaccines to prevent COVID-19; Guidance for Industry. 2022 [cited 2022 Dec]. Available from: https://www.fda.gov/media/142749/download.

4. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine

5. Frequency of Adverse Events in the Placebo Arms of COVID-19 Vaccine Trials

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