PMID- 37750613
OWN - NLM
STAT- MEDLINE
DCOM- 20231207
LR  - 20240125
IS  - 1744-8395 (Electronic)
IS  - 1476-0584 (Linking)
VI  - 22
IP  - 1
DP  - 2023 Jan-Dec
TI  - Harmonizing the collection of solicited adverse events in prophylactic vaccine 
      clinical trials.
PG  - 849-859
LID - 10.1080/14760584.2023.2262571 [doi]
AB  - INTRODUCTION: During the clinical development of a vaccine, study participants 
      are monitored for the occurrence of adverse events (AEs) over a defined period 
      post-vaccination to assess the safety of prophylactic vaccines. Among the safety 
      data collected, a standard practice in prophylactic vaccine clinical trials 
      involves collecting reactogenicity data through daily AE solicitation of 
      pre-defined sets of symptoms (i.e. solicited AEs). AREAS COVERED: This paper aims 
      to propose recommendations to improve and harmonize the collection of active AE 
      solicitation in prophylactic vaccine clinical trials. EXPERT OPINION: We 
      recommend using limited lists of solicited AEs adapted to the vaccine technology 
      and target population. While the US Food and Drug Administration toxicity grading 
      scale is commonly used in adolescents/adults, harmonizing grading criteria in 
      infants/children would facilitate the comparison of vaccines' safety profiles. 
      Solicited systemic AEs should not systematically be considered causally related 
      to vaccination. Collection of solicited AEs should occur in cohorts of a maximum 
      of 1,000 vaccinated participants, as larger cohort sizes do not improve 
      substantially the precision of AE incidence. The incidence of daily solicited AEs 
      should be compared with a control group for improved interpretations of their 
      clinical relevance. These suggestions would improve the characterization of 
      safety profiles of vaccines.
FAU - Cheuvart, Brigitte
AU  - Cheuvart B
AUID- ORCID: 0000-0001-7156-0062
AD  - Clinical Research and Development, GSK, Wavre, Belgium.
FAU - Spiessens, Bart
AU  - Spiessens B
AD  - Statistics and Decision Sciences, Janssen Research & Development, Beerse, 
      Belgium.
FAU - van Heesbeen, Roy
AU  - van Heesbeen R
AD  - Clinical Development, Janssen Vaccines & Prevention, Leiden, Netherlands.
FAU - Hung, Derchieh
AU  - Hung D
AD  - Clinical Development, Seqirus, Melbourne, Australia.
FAU - Andrade, Coralie
AU  - Andrade C
AD  - Clinical Development, Seqirus, Melbourne, Australia.
FAU - Korejwo-Peyramond, Joanna
AU  - Korejwo-Peyramond J
AD  - Patient Safety & Pharmacovigilance, Sanofi, Lyon, France.
FAU - Tavares-Da-Silva, Fernanda
AU  - Tavares-Da-Silva F
AUID- ORCID: 0000-0001-5433-8064
AD  - Clinical Research and Development, GSK, Wavre, Belgium.
AD  - Global Pharmacovigilance and Safety Science department, Organon, Brussels, 
      Belgium.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20231009
PL  - England
TA  - Expert Rev Vaccines
JT  - Expert review of vaccines
JID - 101155475
RN  - 0 (Vaccines)
SB  - IM
MH  - Child
MH  - Infant
MH  - Adult
MH  - Adolescent
MH  - United States
MH  - Humans
MH  - *Vaccines
MH  - Vaccination/adverse effects
MH  - United States Food and Drug Administration
MH  - Incidence
OTO - NOTNLM
OT  - Prophylactic
OT  - reactogenicity
OT  - severity grading system
OT  - solicited adverse event
OT  - vaccine clinical trial
EDAT- 2023/09/26 13:42
MHDA- 2023/12/07 12:43
CRDT- 2023/09/26 08:32
PHST- 2023/12/07 12:43 [medline]
PHST- 2023/09/26 13:42 [pubmed]
PHST- 2023/09/26 08:32 [entrez]
AID - 10.1080/14760584.2023.2262571 [doi]
PST - ppublish
SO  - Expert Rev Vaccines. 2023 Jan-Dec;22(1):849-859. doi: 
      10.1080/14760584.2023.2262571. Epub 2023 Oct 9.