View in EDS

Alternative approaches to phase III clinical trials for vaccine efficacy and licensure: the role of real-world evidence - a meeting report.

Saved in:
Bibliographic Details
Title: Alternative approaches to phase III clinical trials for vaccine efficacy and licensure: the role of real-world evidence - a meeting report.
Authors: de Moerlooze L; P95, Leuven, Belgium., Allen A; Field Epidemiology and Health Protection Units, Public Health England, London, UK., Bartalesi I; GSK, Siena, Italy., Cavaleri M; EMA, Amsterdam, Netherlands., Davenport MP; Infection Analytics Program, Kirby Institute, UNSW Sydney, Kensington, NSW, 2052, Australia., Gessner BD; EpiVac Consulting, Anchorage, AK, USA., Gomes B; Brazilian Health Regulatory Agency (ANVISA), Brasilia, Brazil., Hayford K; Vaccine Medical Affairs, Pfizer, Inc., New York, NY, USA., Izu A; South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Science, University of the Witwatersrand, Johannesburg, South Africa., Izurieta HS; Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, US FDA, Silver Spring, MD, USA., Jenkins VA; Bavarian Nordic Belgium, Brussels, Belgium., Kastner R; Takeda Pharmaceuticals International AG, Zurich, Switzerland., Krause P; Bethesda, MD, USA., Nealon J; Sanofi, Lyon, France., Oostvogels L; MinervaX ApS, Frederiksberg, Denmark., Palmu AA; FVR - Finnish Vaccine Research, Tampere, Finland., Read RC; NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK., Saenz C; Department of Evidence and Intelligence for Action in Health, Pan American Health Organization, Washington, DC, USA., Smith DK; IABS North America, Canada., Tuboi S; Takeda Pharmaceuticals Brazil, São Paulo, Brazil., Vandendriessche F; Ficaja Farma, Huldenberg, Belgium., Baay M; P95, Leuven, Belgium., Craig D; Coalition for Epidemic Preparedness Innovations, P.O. BOX 123, Torshov, 0412, Oslo, Norway., Neels P; IABS, Geneva, Switzerland. Electronic address: pieter.neels@vaccine-advice.be., Bollaert K; P95, Leuven, Belgium. Electronic address: kaatje.bollaerts@p-95.com.
Source: Biologicals : journal of the International Association of Biological Standardization [Biologicals] 2026 May 09; Vol. 95, pp. 101886. Date of Electronic Publication: 2026 May 09.
Publication Type: Journal Article
Journal Info: Publisher: Academic Press Country of Publication: England NLM ID: 9004494 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1095-8320 (Electronic) Linking ISSN: 10451056 NLM ISO Abbreviation: Biologicals Subsets: MEDLINE
Database: MEDLINE Ultimate
FullText Text:
  Availability: 0
Header DbId: mdl
DbLabel: MEDLINE Ultimate
An: 42107403
AccessLevel: 2
PubType: Academic Journal
PubTypeId: academicJournal
PreciseRelevancyScore: 0
IllustrationInfo
Items – Name: Title
  Label: Title
  Group: Ti
  Data: Alternative approaches to phase III clinical trials for vaccine efficacy and licensure: the role of real-world evidence - a meeting report.
– Name: Author
  Label: Authors
  Group: Au
  Data: <searchLink fieldCode="AU" term="%22de+Moerlooze+L%22">de Moerlooze L</searchLink>; P95, Leuven, Belgium.<br /><searchLink fieldCode="AU" term="%22Allen+A%22">Allen A</searchLink>; Field Epidemiology and Health Protection Units, Public Health England, London, UK.<br /><searchLink fieldCode="AU" term="%22Bartalesi+I%22">Bartalesi I</searchLink>; GSK, Siena, Italy.<br /><searchLink fieldCode="AU" term="%22Cavaleri+M%22">Cavaleri M</searchLink>; EMA, Amsterdam, Netherlands.<br /><searchLink fieldCode="AU" term="%22Davenport+MP%22">Davenport MP</searchLink>; Infection Analytics Program, Kirby Institute, UNSW Sydney, Kensington, NSW, 2052, Australia.<br /><searchLink fieldCode="AU" term="%22Gessner+BD%22">Gessner BD</searchLink>; EpiVac Consulting, Anchorage, AK, USA.<br /><searchLink fieldCode="AU" term="%22Gomes+B%22">Gomes B</searchLink>; Brazilian Health Regulatory Agency (ANVISA), Brasilia, Brazil.<br /><searchLink fieldCode="AU" term="%22Hayford+K%22">Hayford K</searchLink>; Vaccine Medical Affairs, Pfizer, Inc., New York, NY, USA.<br /><searchLink fieldCode="AU" term="%22Izu+A%22">Izu A</searchLink>; South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Science, University of the Witwatersrand, Johannesburg, South Africa.<br /><searchLink fieldCode="AU" term="%22Izurieta+HS%22">Izurieta HS</searchLink>; Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, US FDA, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Jenkins+VA%22">Jenkins VA</searchLink>; Bavarian Nordic Belgium, Brussels, Belgium.<br /><searchLink fieldCode="AU" term="%22Kastner+R%22">Kastner R</searchLink>; Takeda Pharmaceuticals International AG, Zurich, Switzerland.<br /><searchLink fieldCode="AU" term="%22Krause+P%22">Krause P</searchLink>; Bethesda, MD, USA.<br /><searchLink fieldCode="AU" term="%22Nealon+J%22">Nealon J</searchLink>; Sanofi, Lyon, France.<br /><searchLink fieldCode="AU" term="%22Oostvogels+L%22">Oostvogels L</searchLink>; MinervaX ApS, Frederiksberg, Denmark.<br /><searchLink fieldCode="AU" term="%22Palmu+AA%22">Palmu AA</searchLink>; FVR - Finnish Vaccine Research, Tampere, Finland.<br /><searchLink fieldCode="AU" term="%22Read+RC%22">Read RC</searchLink>; NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK.<br /><searchLink fieldCode="AU" term="%22Saenz+C%22">Saenz C</searchLink>; Department of Evidence and Intelligence for Action in Health, Pan American Health Organization, Washington, DC, USA.<br /><searchLink fieldCode="AU" term="%22Smith+DK%22">Smith DK</searchLink>; IABS North America, Canada.<br /><searchLink fieldCode="AU" term="%22Tuboi+S%22">Tuboi S</searchLink>; Takeda Pharmaceuticals Brazil, São Paulo, Brazil.<br /><searchLink fieldCode="AU" term="%22Vandendriessche+F%22">Vandendriessche F</searchLink>; Ficaja Farma, Huldenberg, Belgium.<br /><searchLink fieldCode="AU" term="%22Baay+M%22">Baay M</searchLink>; P95, Leuven, Belgium.<br /><searchLink fieldCode="AU" term="%22Craig+D%22">Craig D</searchLink>; Coalition for Epidemic Preparedness Innovations, P.O. BOX 123, Torshov, 0412, Oslo, Norway.<br /><searchLink fieldCode="AU" term="%22Neels+P%22">Neels P</searchLink>; IABS, Geneva, Switzerland. Electronic address: pieter.neels@vaccine-advice.be.<br /><searchLink fieldCode="AU" term="%22Bollaert+K%22">Bollaert K</searchLink>; P95, Leuven, Belgium. Electronic address: kaatje.bollaerts@p-95.com.
– Name: TitleSource
  Label: Source
  Group: Src
  Data: <searchLink fieldCode="JN" term="%229004494%22">Biologicals : journal of the International Association of Biological Standardization</searchLink> [Biologicals] 2026 May 09; Vol. 95, pp. 101886. <i>Date of Electronic Publication: </i>2026 May 09.
– Name: TypePub
  Label: Publication Type
  Group: TypPub
  Data: Journal Article
– Name: TitleSource
  Label: Journal Info
  Group: Src
  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Academic+Press%22">Academic Press </searchLink><i>Country of Publication: </i>England <i>NLM ID: </i>9004494 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1095-8320 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2210451056%22">10451056 </searchLink><i>NLM ISO Abbreviation: </i>Biologicals <i>Subsets: </i>MEDLINE
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=mdl&AN=42107403
RecordInfo BibRecord:
  BibEntity:
    Identifiers:
      – Type: doi
        Value: 10.1016/j.biologicals.2026.101886
    Languages:
      – Code: eng
        Text: English
    PhysicalDescription:
      Pagination:
        StartPage: 101886
    Titles:
      – TitleFull: Alternative approaches to phase III clinical trials for vaccine efficacy and licensure: the role of real-world evidence - a meeting report.
        Type: main
  BibRelationships:
    HasContributorRelationships:
      – PersonEntity:
          Name:
            NameFull: de Moerlooze L
      – PersonEntity:
          Name:
            NameFull: Allen A
      – PersonEntity:
          Name:
            NameFull: Bartalesi I
      – PersonEntity:
          Name:
            NameFull: Cavaleri M
      – PersonEntity:
          Name:
            NameFull: Davenport MP
      – PersonEntity:
          Name:
            NameFull: Gessner BD
      – PersonEntity:
          Name:
            NameFull: Gomes B
      – PersonEntity:
          Name:
            NameFull: Hayford K
      – PersonEntity:
          Name:
            NameFull: Izu A
      – PersonEntity:
          Name:
            NameFull: Izurieta HS
      – PersonEntity:
          Name:
            NameFull: Jenkins VA
      – PersonEntity:
          Name:
            NameFull: Kastner R
      – PersonEntity:
          Name:
            NameFull: Krause P
      – PersonEntity:
          Name:
            NameFull: Nealon J
      – PersonEntity:
          Name:
            NameFull: Oostvogels L
      – PersonEntity:
          Name:
            NameFull: Palmu AA
      – PersonEntity:
          Name:
            NameFull: Read RC
      – PersonEntity:
          Name:
            NameFull: Saenz C
      – PersonEntity:
          Name:
            NameFull: Smith DK
      – PersonEntity:
          Name:
            NameFull: Tuboi S
      – PersonEntity:
          Name:
            NameFull: Vandendriessche F
      – PersonEntity:
          Name:
            NameFull: Baay M
      – PersonEntity:
          Name:
            NameFull: Craig D
      – PersonEntity:
          Name:
            NameFull: Neels P
      – PersonEntity:
          Name:
            NameFull: Bollaert K
    IsPartOfRelationships:
      – BibEntity:
          Dates:
            – D: 09
              M: 05
              Text: 2026 May 09
              Type: published
              Y: 2026
          Identifiers:
            – Type: issn-electronic
              Value: 1095-8320
          Numbering:
            – Type: volume
              Value: 95
          Titles:
            – TitleFull: Biologicals : journal of the International Association of Biological Standardization
              Type: main
ResultId 1