Open-label, randomised, parallel-group, multicentre study to evaluate the safety, tolerability and immunogenicity of an AS03B/oil-in-water emulsion-adjuvanted (AS03B) split-virion versus non-adjuvanted whole-virion H1N1 influenza vaccine in UK children 6 months to 12 years of age

CS Waddington; N Andrews; K Hoschler; WT Walker; C Oeser; A Reiner; T John; S Wilkins; M Casey; PE Eccleston; RJ Allen; I Okike; S Ladhani; E Sheasby; P Waight; AC Collinson; PT Heath; A Finn; SN Faust; MD Snape; E Miller; AJ Pollard

doi:10.3310/hta14460-01

Health Technology Assessment (Oct 2010)

Open-label, randomised, parallel-group, multicentre study to evaluate the safety, tolerability and immunogenicity of an AS03B/oil-in-water emulsion-adjuvanted (AS03B) split-virion versus non-adjuvanted whole-virion H1N1 influenza vaccine in UK children 6 months to 12 years of age

CS Waddington,
N Andrews,
K Hoschler,
WT Walker,
C Oeser,
A Reiner,
T John,
S Wilkins,
M Casey,
PE Eccleston,
RJ Allen,
I Okike,
S Ladhani,
E Sheasby,
P Waight,
AC Collinson,
PT Heath,
A Finn,
SN Faust,
MD Snape,
E Miller,
AJ Pollard

Affiliations

CS Waddington: Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK
N Andrews: Centre for Infections, Health Protection Agency, London, UK
K Hoschler: Centre for Infections, Health Protection Agency, London, UK
WT Walker: University of Southampton Wellcome Trust Clinical Research Facility and Division of Infection, Inflammation & Immunity, Southampton, UK
C Oeser: St George’s Vaccine Institute, London, UK
A Reiner: Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK
T John: Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK
S Wilkins: Royal Devon & Exeter NHS Foundation Trust, Exeter, UK
M Casey: University of Southampton Wellcome Trust Clinical Research Facility and Division of Infection, Inflammation & Immunity, Southampton, UK
PE Eccleston: Bristol Children’s Vaccine Centre, University Hospitals Bristol NHS Foundation Trust and University of Bristol, Bristol, UK
RJ Allen: Bristol Children’s Vaccine Centre, University Hospitals Bristol NHS Foundation Trust and University of Bristol, Bristol, UK
I Okike: St George’s Vaccine Institute, London, UK
S Ladhani: Centre for Infections, Health Protection Agency, London, UK
E Sheasby: Centre for Infections, Health Protection Agency, London, UK
P Waight: Centre for Infections, Health Protection Agency, London, UK
AC Collinson: Royal Devon & Exeter NHS Foundation Trust, Exeter, UK
PT Heath: St George’s Vaccine Institute, London, UK
A Finn: Bristol Children’s Vaccine Centre, University Hospitals Bristol NHS Foundation Trust and University of Bristol, Bristol, UK
SN Faust: University of Southampton Wellcome Trust Clinical Research Facility and Division of Infection, Inflammation & Immunity, Southampton, UK
MD Snape: Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK
E Miller: Centre for Infections, Health Protection Agency, London, UK
AJ Pollard: Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK

DOI: https://doi.org/10.3310/hta14460-01
Journal volume & issue: Vol. 14, no. 46

Abstract

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Objective: To evaluate the safety, tolerability and immunogenicity of an AS03B/oil-in-water emulsion-adjuvanted (AS03B) split-virion versus non-adjuvanted whole-virion H1N1 influenza vaccine in UK children aged 6 months to 12 years. Design: Multicentre, randomised, head-to-head, open-label trial. Setting: Five UK sites (Oxford, Bristol, Southampton, Exeter and London). Participants: Children aged 6 months to 38.0°C in those under 5 years of age (8.9% vs 22.4%). Conclusion: The adjuvanted vaccine, although reactogenic, was more immunogenic, especially in younger children, indicating the potential for improved immunogenicity of influenza vaccines in this age group. Trial registration number: ISRCTN89141709

Published in Health Technology Assessment

ISSN: 1366-5278 (Print); 2046-4924 (Online)
Publisher: NIHR Journals Library
Country of publisher: United Kingdom
LCC subjects: Medicine: Medicine (General): Medical technology
Website: https://www.journalslibrary.nihr.ac.uk/hta/

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