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
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. Se...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , |
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| Language: | English |
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NIHR Journals Library
2010-10-01
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| Series: | Health Technology Assessment |
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| Online Access: | https://doi.org/10.3310/hta14460-01 |
| _version_ | 1818127360770179072 |
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| author | 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 |
| author_facet | 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 |
| author_sort | CS Waddington |
| collection | DOAJ |
| description | 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 < 13 years, for whom a parent or guardian had provided written informed consent and who were able to comply with study procedures, were eligible for inclusion. Interventions: A tocopherol/oil-in-water emulsion-adjuvanted (AS03B) egg culture-derived split-virion H1N1 vaccine and a non-adjuvanted cell culture-derived whole-virion vaccine, given as a two-dose schedule, 21 days apart, were compared. Participants were grouped into those aged 6 months to < 3 years (younger group) and 3 years to < 13 years of age (older group) and were randomised by study investigators (1 : 1 ratio) to receive one of the two vaccines. Vaccines were administered by intramuscular injection (deltoid or anterior-lateral thigh, depending on age and muscle bulk). Local reactions and systemic symptoms were collected for 1 week post immunisation, and serum was collected at baseline and after the second dose. To assess safety and tolerability, parents or guardians recorded the following information in diary cards from days 0–7 post vaccination: axillary temperature, injection site reactions, solicited and unsolicited systemic symptoms, and medications. Main outcome measure: Comparison between vaccines of the percentage of participants demonstrating seroconversion by microneutralisation assay. Results: Among 937 children receiving vaccine, per-protocol seroconversion rates were higher after the AS03B-adjuvanted vaccine than after the whole-virion vaccine (98.2% vs 80.1% in children < 3 years, 99.1% vs 95.9% among those aged 3–12 years), as were severe local reactions (3.6% vs 0.0% in those under 5 years, 7.8% vs 1.1% in those aged 5–12 years), irritability in children < 5 years (46.7% vs 32.0%), and muscle pain in older children (28.9% vs 13.2%). The second dose of the adjuvanted vaccine was more reactogenic than the first, especially for fever > 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 |
| first_indexed | 2024-12-11T07:16:07Z |
| format | Article |
| id | doaj.art-92e96ae7c37d4a7aa26da62408e36e28 |
| institution | Directory Open Access Journal |
| issn | 1366-5278 2046-4924 |
| language | English |
| last_indexed | 2024-12-11T07:16:07Z |
| publishDate | 2010-10-01 |
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| series | Health Technology Assessment |
| spelling | doaj.art-92e96ae7c37d4a7aa26da62408e36e282022-12-22T01:16:14ZengNIHR Journals LibraryHealth Technology Assessment1366-52782046-49242010-10-01144610.3310/hta14460-0109/94/01Open-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 ageCS Waddington0N Andrews1K Hoschler2WT Walker3C Oeser4A Reiner5T John6S Wilkins7M Casey8PE Eccleston9RJ Allen10I Okike11S Ladhani12E Sheasby13P Waight14AC Collinson15PT Heath16A Finn17SN Faust18MD Snape19E Miller20AJ Pollard21Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UKCentre for Infections, Health Protection Agency, London, UKCentre for Infections, Health Protection Agency, London, UKUniversity of Southampton Wellcome Trust Clinical Research Facility and Division of Infection, Inflammation & Immunity, Southampton, UKSt George’s Vaccine Institute, London, UKOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UKOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UKRoyal Devon & Exeter NHS Foundation Trust, Exeter, UKUniversity of Southampton Wellcome Trust Clinical Research Facility and Division of Infection, Inflammation & Immunity, Southampton, UKBristol Children’s Vaccine Centre, University Hospitals Bristol NHS Foundation Trust and University of Bristol, Bristol, UKBristol Children’s Vaccine Centre, University Hospitals Bristol NHS Foundation Trust and University of Bristol, Bristol, UKSt George’s Vaccine Institute, London, UKCentre for Infections, Health Protection Agency, London, UKCentre for Infections, Health Protection Agency, London, UKCentre for Infections, Health Protection Agency, London, UKRoyal Devon & Exeter NHS Foundation Trust, Exeter, UKSt George’s Vaccine Institute, London, UKBristol Children’s Vaccine Centre, University Hospitals Bristol NHS Foundation Trust and University of Bristol, Bristol, UKUniversity of Southampton Wellcome Trust Clinical Research Facility and Division of Infection, Inflammation & Immunity, Southampton, UKOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UKCentre for Infections, Health Protection Agency, London, UKOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UKObjective: 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 < 13 years, for whom a parent or guardian had provided written informed consent and who were able to comply with study procedures, were eligible for inclusion. Interventions: A tocopherol/oil-in-water emulsion-adjuvanted (AS03B) egg culture-derived split-virion H1N1 vaccine and a non-adjuvanted cell culture-derived whole-virion vaccine, given as a two-dose schedule, 21 days apart, were compared. Participants were grouped into those aged 6 months to < 3 years (younger group) and 3 years to < 13 years of age (older group) and were randomised by study investigators (1 : 1 ratio) to receive one of the two vaccines. Vaccines were administered by intramuscular injection (deltoid or anterior-lateral thigh, depending on age and muscle bulk). Local reactions and systemic symptoms were collected for 1 week post immunisation, and serum was collected at baseline and after the second dose. To assess safety and tolerability, parents or guardians recorded the following information in diary cards from days 0–7 post vaccination: axillary temperature, injection site reactions, solicited and unsolicited systemic symptoms, and medications. Main outcome measure: Comparison between vaccines of the percentage of participants demonstrating seroconversion by microneutralisation assay. Results: Among 937 children receiving vaccine, per-protocol seroconversion rates were higher after the AS03B-adjuvanted vaccine than after the whole-virion vaccine (98.2% vs 80.1% in children < 3 years, 99.1% vs 95.9% among those aged 3–12 years), as were severe local reactions (3.6% vs 0.0% in those under 5 years, 7.8% vs 1.1% in those aged 5–12 years), irritability in children < 5 years (46.7% vs 32.0%), and muscle pain in older children (28.9% vs 13.2%). The second dose of the adjuvanted vaccine was more reactogenic than the first, especially for fever > 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: ISRCTN89141709https://doi.org/10.3310/hta14460-01virus sheddinginfluenzapandemic h1n1 influenzaenvironmental depositiontransmissionbioaerosol |
| spellingShingle | 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 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 Health Technology Assessment virus shedding influenza pandemic h1n1 influenza environmental deposition transmission bioaerosol |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | virus shedding influenza pandemic h1n1 influenza environmental deposition transmission bioaerosol |
| url | https://doi.org/10.3310/hta14460-01 |
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