Safety and immunogenicity of AS03B adjuvanted split virion versus non-adjuvanted whole virion H1N1 influenza vaccine in UK children aged 6 months-12 years: open label, randomised, parallel group, multicentre study

Waddington, Claire S.; Walker, Woolf T.; Oeser, Clarissa; Reiner, A; John, Tessa M.; Wilkins, S; Casey, Michelle; Eccleston, Philippa; Allen, R J; Okike, Ifeanyichukwu; Ladhani, Shamez; Sheasby, Elizabeth; Höschler, Katja; Andrews, Nick; Waight, Pauline; Collinson, Andrew; Heath, Paul T; Finn, Adam; Faust, Saul N; Snape, Matthew D.; Miller, Elizabeth; Pollard, Andrew J.

doi:10.1136/bmj.c2649

Cited by 156 publications

(135 citation statements)

References 24 publications

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“…Our study and a similar study in children, 91 reveal heightened immunogenicity of AS03 A -adjuvanted vaccine in comparison with WV vaccine by HI and MN. Waddington et al 91 did not measure antibodies after the first vaccine dose or assess vaccine immunogenicity using CHMP criteria.…”

Section: Chaptermentioning

confidence: 67%

A randomised, partially observer blind, multicentre, head-to-head comparison of a two-dose regimen of Baxter and GlaxoSmithKline H1N1 pandemic vaccines, administered 21 days apart

Nicholson

Abrams²,

Batham³

et al. 2010

Health Technol Assess

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A randomised, partially observer-blind, multicentre, head-to-head comparison of a two-dose regimen of Baxter and GlaxoSmithKline H1N1 pandemic vaccines, administered 21 days apart KG Participants: Three hundred and forty-seven subjects were identified and randomised to AS03 A -adjuvanted split-virion H1N1 vaccine or whole-virion (WV) vaccine in age groups [≥ 18-44 years (n = 140), ≥ 45-64 years (n = 136) and ≥ 65 years (n = 71)]. Interventions: Vaccine was administered by intramuscular injection into the deltoid muscle of the non-dominant arm. One hundred and seventy-five randomised subjects were allocated AS03 A -adjuvanted split H1N1 vaccine; one hundred and sixty-nine subjects had a second dose of the same vaccine 21 days later. One hundred and seventy-two subjects were allocated WV vaccine; one hundred and seventy-one subjects had a second dose of the same vaccine 21 days later. Serum samples for antibody measurements were collected on days 0 (before the first vaccination), 7, 14, 21 (before the second vaccination), 28, 35, 42 and 180. Subjects were observed for local and systemic reactions for 30 minutes after each injection, and for the next 7 days they recorded, in self-completed diaries, the severity of solicited local (pain, bruising, erythema and swelling) and systemic symptoms (chills, malaise, muscle aches, nausea and headache), oral temperature and use of analgesic medications. Main outcome measures: Vaccine immunogenicity using the CHMP and the FDA licensing criteria. Antibody titres were measured using haemagglutination inhibition (HI) and microneutralisation (MN) assays at baseline and 7, 14 and 21 days after each vaccination and at day 180. The three immunogenicity criteria end points were the seroprotection rate, the seroconversion rate and the mean-fold titre elevation. Results: Both vaccine doses were given in 340 subjects (98%). Data from 680 (99%) of 687 issued diary cards were returned. Sera were obtained from 340 (98.0%), 333 (96.0%), 341 (98.3%), 331 (95.4%), Abstract 196 329 (94.8%) and 332 (95.7%) subjects on days 7, 14, 21, 28, 35 and 42, respectively. Three hundred and fortysix and 345 subjects were included in the safety and immunogenicity analyses, respectively. Prevaccination antibody was detected by HI (titre ≥ 1 : 8) and MN (titre ≥ 1 : 10) in 14% and 31% of subjects, respectively. Among the 298 (85.9%) subjects without baseline antibody on HI assay, a titre of ≥ 1 : 40 (seroprotection) was achieved after a single dose of AS03 A -adjuvanted vaccine and WV vaccine by day 21 in 93.0% and 65.5%, respectively, of subjects between 18 and 44 years, 76.4% and 36.1% of subjects between 45 and 64 years, and 53.1% and 30.0% of subjects ≥ 65 years. Among all 347 subjects, a titre of ≥ 1 : 40 was achieved after a single dose of AS03 A -adjuvanted vaccine and WV vaccine by day 21 in 94.0% and 71.4%, respectively, of subjects between 18 and 44 years, 77.3% and 38.8% of subjects between 45 and 64 years, and 51.4% and 32.4% of subjects ≥ 65 years. The age-adjusted odds ratio (OR) for ...

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Section: Chaptermentioning

confidence: 67%

A randomised, partially observer blind, multicentre, head-to-head comparison of a two-dose regimen of Baxter and GlaxoSmithKline H1N1 pandemic vaccines, administered 21 days apart

Nicholson

Abrams²,

Batham³

et al. 2010

Health Technol Assess

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show abstract

“…Both, adjuvanted and non-adjuvanted, vaccines were well tolerated. [10][11][12] Nevertheless, literature shows that after vaccination with adjuvanted pandemic influenza vaccines, such as Pandemrix ® , the incidence of local reactions and systemic AEs was higher than after vaccination with non-adjuvanted pandemic influenza vaccines. 13 In children, especially the occurrence of fever was much higher.…”

Section: Discussionmentioning

confidence: 99%

“…13 In children, especially the occurrence of fever was much higher. 10,11 In the children who participated in our study, high proportions of fever were reported. Besides the role of the adjuvant, there were some other possible explanations for these high rates of fever.…”

Section: Discussionmentioning

confidence: 99%

Two doses of pandemic influenza A(H1N1) vaccine: Tolerability in healthy young children in the Netherlands

Klooster¹,

Kemmeren²,

Melker³

et al. 2011

Human Vaccines

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“…70,71,81 A wider variety of events have been reported in children. 79,80 However, the frequency of occurrence of the AEs is not significantly different from subjects administered a placebo or an ECE-derived vaccine.…”

Section: Introductionmentioning

confidence: 98%

“…67,70,71,79 The most frequently reported local AEs have been pain at injection site (10-43% of the subjects), followed by redness, swelling, induration and ecchymosis. 67,70,71,[79][80][81] Total systemic AEs have been reported in 18-51% of the subjects, 65,68,69 the most common being headache, fatigue, myalgia and malaise (3-20% of the subjects) in adults as well as the elderly. 70,71,81 A wider variety of events have been reported in children.…”

Section: Introductionmentioning

confidence: 99%

Cell culture-based influenza vaccines: A necessary and indispensable investment for the future

Hegde

2015

Human Vaccines & Immunotherapeutics

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Safety and immunogenicity of AS03B adjuvanted split virion versus non-adjuvanted whole virion H1N1 influenza vaccine in UK children aged 6 months-12 years: open label, randomised, parallel group, multicentre study

Abstract: Objectives To compare the safety, reactogenicity, and immunogenicity of an adjuvanted split virion H1N1 vaccine and a non-adjuvanted whole virion vaccine used in the pandemic immunisation programme in the United Kingdom.

Cited by 156 publications

References 24 publications

A randomised, partially observer blind, multicentre, head-to-head comparison of a two-dose regimen of Baxter and GlaxoSmithKline H1N1 pandemic vaccines, administered 21 days apart

A randomised, partially observer blind, multicentre, head-to-head comparison of a two-dose regimen of Baxter and GlaxoSmithKline H1N1 pandemic vaccines, administered 21 days apart

Two doses of pandemic influenza A(H1N1) vaccine: Tolerability in healthy young children in the Netherlands

Cell culture-based influenza vaccines: A necessary and indispensable investment for the future

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