PMID- 31884676
OWN - NLM
STAT- MEDLINE
DCOM- 20201109
LR  - 20201109
IS  - 1179-1942 (Electronic)
IS  - 0114-5916 (Print)
IS  - 0114-5916 (Linking)
VI  - 43
IP  - 3
DP  - 2020 Mar
TI  - Brand-Specific Enhanced Safety Surveillance of GSK's Quadrivalent Seasonal 
      Influenza Vaccine in Belgium, Germany and Spain for the 2018/2019 Season.
PG  - 265-279
LID - 10.1007/s40264-019-00893-4 [doi]
AB  - INTRODUCTION: Seasonal influenza causes numerous deaths worldwide each year. 
      Annual vaccination for disease prevention is crucial. Seasonal vaccines are 
      updated each year to closely match circulating strains. OBJECTIVE: To comply with 
      European Medicines Agency (EMA) guidance, an enhanced safety study was conducted 
      to rapidly collect and assess adverse events (AEs) within 7 days following 
      vaccination with GSK's inactivated quadrivalent seasonal influenza vaccine (IIV4) 
      in 2018/2019. METHODS: A customised AE reporting card (AERC) and standardised 
      electronic data reporting application were used in Belgium, Germany and Spain in 
      adult and paediatric subjects in this study. RESULTS: In 2018, 1060 subjects 
      vaccinated with one dose of GSK's IIV4 were enrolled (all subjects in Belgium and 
      Germany were adults, and 75% and 25% of subjects in Spain were children and 
      adults, respectively). In Spain, 139 eligible children later received a second 
      dose. Overall 1035 subjects completed the study. After dose 1 and dose 2, 98.3% 
      and 100% of subjects, respectively, returned the completed AERC. Over the study 
      period, 43.0% (456/1060 post dose 1) and 23.7% (33/139 post dose 2) of subjects 
      reported at least one AE within 7 days after immunisation. The most frequently 
      reported categories of AEs were General and Administration Site (e.g. injection 
      site pain, swelling, erythema) and Respiratory Disorders (e.g. rhinorrhoea, 
      cough, nasal congestion). There were no deaths and no serious AEs deemed related 
      to GSK's IIV4. CONCLUSION: In compliance with EMA guidance, this study design 
      allowed for near real-time assessment of AEs. No safety signals were detected at 
      any point during the study period. The study supports and confirms the acceptable 
      safety profile of GSK's IIV4. CLINICALTRIALS. GOV IDENTIFIER: NCT03688620.
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 - Nguyen, Bach-Yen
AU  - Nguyen BY
AD  - GSK, Rockville, MD, USA.
FAU - Damaso, Silvia
AU  - Damaso S
AUID- ORCID: 0000-0003-4851-4396
AD  - GSK, Wavre, Belgium.
FAU - Godderis, Lode
AU  - Godderis L
AD  - Environment and Health, Department of Public Health and Primary Care, KU Leuven, 
      Louvain, Belgium.
AD  - IDEWE Occupational Health Services, Heverlee-Leuven, Belgium.
FAU - Martinez-Gomez, Xavier
AU  - Martinez-Gomez X
AD  - Hospital Universitari Vall d'Hebron, Barcelona, Spain.
FAU - Eckermann, Tamara
AU  - Eckermann T
AD  - General Practitioner, Munich, Germany.
FAU - Loos, Hugo
AU  - Loos H
AD  - General Practitioner, Geel, Belgium.
FAU - Salamanca de la Cueva, Ignacio
AU  - Salamanca de la Cueva I
AD  - Instituto Hispalense de Pediatria, Seville, Spain.
FAU - Shende, Vishvesh
AU  - Shende V
AUID- ORCID: 0000-0002-2245-7330
AD  - VPN Consultancy Ltd (On Behalf of GSK), London, UK.
FAU - Schmidt, Alexander C
AU  - Schmidt AC
AUID- ORCID: 0000-0003-4757-3335
AD  - GSK, Rockville, MD, USA.
AD  - Gates Medical Research Institute, Cambridge, MA, USA.
FAU - Yeakey, Anne
AU  - Yeakey A
AUID- ORCID: 0000-0003-3691-3445
AD  - GSK, Rockville, MD, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT03688620
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - New Zealand
TA  - Drug Saf
JT  - Drug safety
JID - 9002928
RN  - 0 (Influenza Vaccines)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - *Adverse Drug Reaction Reporting Systems
MH  - Aged
MH  - Belgium/epidemiology
MH  - Child
MH  - Child, Preschool
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology
MH  - Germany/epidemiology
MH  - Humans
MH  - Infant
MH  - Influenza Vaccines/*adverse effects/*immunology
MH  - Influenza, Human/*prevention & control
MH  - Middle Aged
MH  - *Product Surveillance, Postmarketing
MH  - Risk Factors
MH  - Seasons
MH  - Spain/epidemiology
MH  - Vaccination/adverse effects
MH  - Young Adult
PMC - PMC7048703
COIS- Gael Dos Santos, Silvia Damaso, Anne Yeakey and Bach-Yen Nguyen declare they are 
      employed by the GSK group of companies and hold shares in the GSK group of 
      companies. Xavier Martinez Gomez declares having received financial support from 
      PaxVax for participation on advisory boards for vaccines and from Pfizer for 
      participation at conferences. Alexander C. Schmidt declares he was employed by 
      the GSK group of companies at the time of the study conduct and holds shares in 
      the GSK group of companies. Vishvesh Shende declares he is employed by VPN 
      Consultancy Limited, working on behalf of the GSK group of companies. Hugo Loos, 
      Lode Godderis, Tamara Eckermann and Ignacio Salamanca de la Cueva declare they 
      have no conflicts of interest.
EDAT- 2019/12/31 06:00
MHDA- 2020/11/11 06:00
PMCR- 2019/12/28
CRDT- 2019/12/30 06:00
PHST- 2019/12/31 06:00 [pubmed]
PHST- 2020/11/11 06:00 [medline]
PHST- 2019/12/30 06:00 [entrez]
PHST- 2019/12/28 00:00 [pmc-release]
AID - 10.1007/s40264-019-00893-4 [pii]
AID - 893 [pii]
AID - 10.1007/s40264-019-00893-4 [doi]
PST - ppublish
SO  - Drug Saf. 2020 Mar;43(3):265-279. doi: 10.1007/s40264-019-00893-4.