PMID- 34961900
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220216
IS  - 2193-8229 (Print)
IS  - 2193-6382 (Electronic)
IS  - 2193-6382 (Linking)
VI  - 11
IP  - 1
DP  - 2022 Feb
TI  - Brand-Specific Enhanced Safety Surveillance Study of GSK's Quadrivalent Seasonal 
      Influenza Vaccine, Conducted During the COVID-19 Pandemic, in Belgium, Germany 
      and Spain, for the 2020/21 Season.
PG  - 463-483
LID - 10.1007/s40121-021-00571-y [doi]
AB  - INTRODUCTION: Seasonal influenza poses a major public health burden worldwide. 
      Influenza vaccines, updated yearly to match circulating strains based on World 
      Health Organization (WHO) recommendations, are the cornerstone of prevention and 
      require regular monitoring. The COVID-19 pandemic is expected to cause 
      logistical, site access and medical staff constraints and could affect the safety 
      profile of influenza vaccines. METHODS: Following European Medicines Agency 
      guidance, an enhanced safety surveillance (ESS) study assessed the frequency and 
      severity of predefined and other adverse events (AEs) occurring within 7 days of 
      receiving GSK's inactivated quadrivalent seasonal influenza vaccine (IIV4), in 
      Belgium, Germany and Spain in 2020/21, using adverse drug reaction (ADR) cards. 
      RESULTS: During the 2020/21 influenza season, 1054 participants vaccinated with 
      GSK's IIV4 were enrolled (all adults in Belgium and Germany, 30% adults/70% 
      children in Spain); 96 eligible children received a second dose. Overall, 1042 
      participants completed the study. After doses 1 and 2, 98.9% and 100% of 
      participants, respectively, returned their completed ADR card. After doses 1 and 
      2, 37.8% (398/1054) and 13.5% (13/96) of participants, respectively, reported at 
      least one AE. The most frequently reported categories of AEs were "general 
      disorders and administration site conditions" (e.g. injection site pain) and 
      "nervous system disorders" (e.g. headache). There were no deaths or serious AEs 
      deemed related to GSK's IIV4. CONCLUSION: This ESS study assessed AEs in near 
      real time. The COVID-19 pandemic did not alter the safety profile of GSK's IIV4. 
      No safety signals were detected during the study, which confirms the excellent 
      safety profile of GSK's IIV4.
CI  - (c) 2021. The GSK group of companies.
FAU - Dos Santos, Gael
AU  - Dos Santos G
AUID- ORCID: 0000-0001-8623-3478
AD  - GSK, Wavre, Belgium. gael.x.dos-santos@gsk.com.
FAU - Wang, Hao
AU  - Wang H
AUID- ORCID: 0000-0001-8293-6969
AD  - GSK, Amsterdam, The Netherlands.
FAU - Jindal, Pooja
AU  - Jindal P
AUID- ORCID: 0000-0001-6528-8875
AD  - Parexel International, Chandigarh, India, C/O GSK, Rockville, MD, USA.
FAU - Rybo, Maria
AU  - Rybo M
AUID- ORCID: 0000-0002-6678-0455
AD  - PPD, Sundbyberg, Sweden.
FAU - Roul, Helene
AU  - Roul H
AUID- ORCID: 0000-0001-9912-6540
AD  - Keyrus Life Science, Levallois-Perret, France, C/O GSK, Wavre, Belgium.
FAU - Pallem, Sridevi
AU  - Pallem S
AUID- ORCID: 0000-0002-8435-7132
AD  - Keyrus Life Science, New York, NY, USA, C/O GSK, New York, NY, USA.
FAU - Eckermann, Tamara
AU  - Eckermann T
AD  - Hausarztpraxis Heimeranplatz, Munich, Germany.
FAU - Godderis, Lode
AU  - Godderis L
AUID- ORCID: 0000-0003-4764-8835
AD  - Environment and Health, Department of Public Health and Primary Care, KU Leuven, 
      Leuven, Belgium.
AD  - External Service for Prevention and Protection at Work, IDEWE, Heverlee, Belgium.
FAU - Martinez Gomez, Xavier
AU  - Martinez Gomez X
AUID- ORCID: 0000-0003-4583-9734
AD  - Hospital Universitari Vall d'Hebron, Barcelona, Spain.
FAU - Godard, Eric
AU  - Godard E
AD  - PPD, Brussels, Belgium.
FAU - Soler, Muriel
AU  - Soler M
AUID- ORCID: 0000-0002-8169-0730
AD  - 4Clinics, Waterloo, Belgium, C/O GSK, Wavre, Belgium.
FAU - Yousefi, Mitra
AU  - Yousefi M
AUID- ORCID: 0000-0003-3076-5701
AD  - GSK, Rockville, MD, USA.
FAU - Salamanca de la Cueva, Ignacio
AU  - Salamanca de la Cueva I
AUID- ORCID: 0000-0003-0561-9913
AD  - Instituto Hispalense de Pediatria, Seville, Spain.
FAU - Nwoji, Ugo
AU  - Nwoji U
AUID- ORCID: 0000-0002-2946-703X
AD  - GSK, Rockville, MD, USA.
LA  - eng
GR  - study number 207750/GlaxoSmithKline Biologicals SA/
PT  - Journal Article
DEP - 20211227
PL  - New Zealand
TA  - Infect Dis Ther
JT  - Infectious diseases and therapy
JID - 101634499
PMC - PMC8711683
OTO - NOTNLM
OT  - AlphaRix Tetra
OT  - Fluarix Tetra
OT  - Infectious disease
OT  - Influenza
OT  - Influsplit Tetra
OT  - Post-marketing surveillance
OT  - Vaccination
OT  - Vaccine Safety
OT  - Vaccine monitoring
EDAT- 2021/12/29 06:00
MHDA- 2021/12/29 06:01
PMCR- 2021/12/27
CRDT- 2021/12/28 06:38
PHST- 2021/09/22 00:00 [received]
PHST- 2021/11/17 00:00 [accepted]
PHST- 2021/12/29 06:00 [pubmed]
PHST- 2021/12/29 06:01 [medline]
PHST- 2021/12/28 06:38 [entrez]
PHST- 2021/12/27 00:00 [pmc-release]
AID - 10.1007/s40121-021-00571-y [pii]
AID - 571 [pii]
AID - 10.1007/s40121-021-00571-y [doi]
PST - ppublish
SO  - Infect Dis Ther. 2022 Feb;11(1):463-483. doi: 10.1007/s40121-021-00571-y. Epub 
      2021 Dec 27.