European Medicines Agency - Regulatory - Regulation of medicines

3 - Specific competencies and capacity to provide export advice

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UKPVG - United Kingdom Paediatric Vaccine Group
Number of peer reviewed publications in the last 5 years 12 Phase II study of a three-dose primary vaccination course of DTPa-IPV/Hib-MenC-TT followed by a 12-month Hib-MenC-TT booster in healthy infants. Khatami A, Snape MD, Ohene-Kena B, Young K, Oeser C, Michaelis LJ, Macleod E, Smee H, Van Der Meeren O, Leyssen M, Caubet M, Yu LM, Heath PT, Faust SN, Finn A, Pollard AJ. Pediatr Infect Dis J. 2013 Jun;32(6):675-81 Immunogenicity and tolerability of recombinant serogroup B meningococcal vaccine administered with or without routine infant vaccinations according to different immunization schedules: a randomized controlled trial. Gossger N, Snape MD, Yu LM, Finn A, Bona G, Esposito S, Principi N, Diez-Domingo J, Sokal E, Becker B, Kieninger D, Prymula R, Dull P, Ypma E, Toneatto D, Kimura A, Pollard AJ; European MenB Vaccine Study Group. JAMA. 2012 Feb 8;307(6):573-82 Immunogenicity and reactogenicity of a 13-valent-pneumococcal conjugate vaccine administered at 2, 4, and 12 months of age: a double-blind randomized active-controlled trial. Snape MD, Klinger CL, Daniels ED, John TM, Layton H, Rollinson L, Pestridge S, Dymond S, Galiza E, Tansey S, Scott DA, Baker SA, Jones TR, Yu LM, Gruber WC, Emini EA, Faust SN, Finn A, Heath PT, Pollard AJ. Pediatr Infect Dis J. 2010 Dec;29(12):e80-90. H1N1 antibody persistence 1 year after immunization with an adjuvanted or whole-virion pandemic vaccine and immunogenicity and reactogenicity of subsequent seasonal influenza vaccine: a multicenter follow-on study. Walker WT, de Whalley P, Andrews N, Oeser C, Casey M, Michaelis L, Hoschler K, Harrill C, Moulsdale P, Thompson B, Jones C, Chalk J, Kerridge S, John TM, Okike I, Ladhani S, Tomlinson R, Heath PT, Miller E, Faust SN, Snape MD, Finn A, Pollard AJ. Clin Infect Dis. 2012 Mar 1;54(5):661-9. 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 CS, Walker WT, Oeser C, Reiner A, John T, Wilkins S, Casey M, Eccleston PE, Allen RJ, Okike I, Ladhani S, Sheasby E, Hoschler K, Andrews N, Waight P, Collinson AC, Heath PT, Finn A, Faust SN, Snape MD, Miller E, Pollard AJ. BMJ. 2010 May 27;340 Immunogenicity of reduced dose priming schedules of serogroup C meningococcal conjugate vaccine followed by booster at 12 months in infants: open label randomised controlled trial. Pace D, Khatami A, McKenna J, Campbell D, Attard-Montalto S, Birks J, Voysey M, White C, Finn A, Macloed E, Faust SN, Kent AL, Heath PT, Borrow R, Snape MD, Pollard AJ. BMJ. 2015 Apr 1;350:h1554. Meningococcal carriage in adolescents in the United Kingdom to inform timing of an adolescent vaccination strategy. Jeppesen CA, Snape MD, Robinson H, Gossger N, John TM, Voysey M, Ladhani S, Okike IO, Oeser C, Kent A, Oliver J, Taylor P, Morales-Aza B, Clarke SC, Casey M, Martins F, Kitchin NR, Anderson AS, Jones H, Jansen KU, Eiden J, Pedneault L, Heath PT, Finn A, Faust SN, Pollard AJ. J Infect. 2015 Jul;71(1):43-52. doi: 10.1016/j.jinf.2015.02.006. Safety of live attenuated influenza vaccine in atopic children with egg allergy.Turner PJ, Southern J, Andrews NJ, Miller E, Erlewyn-Lajeunesse M; SNIFFLE Study Investigators. J Allergy Clin Immunol. 2015 Aug;136(2):376-81. Immunological effect of administration of sequential doses of Haemophilus influenzae type b and pneumococcal conjugate vaccines in the same versus alternating limbs in the routine infant immunisation schedule: an open-label randomised controlled trial. Iro MA, Khatami A, Marshall AS, Pace D, Voysey M, McKenna J, Campbell D, Attard-Montalto S, Finn A, White C, Faust SN, Kent A, Heath PT, MacLeod E, Stanford E, Findlow H, Almond R, Bai X, Borrow R, Snape MD, Pollard AJ. Lancet Infect Dis. 2015 Feb;15(2):172-80. Effect of a quadrivalent meningococcal ACWY glycoconjugate or a serogroup B meningococcal vaccine on meningococcal carriage: an observer-blind, phase 3 randomised clinical trial. Read RC, Baxter D, Chadwick DR, Faust SN, Finn A, Gordon SB, Heath PT, Lewis DJ, Pollard AJ, Turner DP, Bazaz R, Ganguli A, Havelock T, Neal KR, Okike IO, Morales-Aza B, Patel K, Snape MD, Williams J, Gilchrist S, Gray SJ, Maiden MC, Toneatto D, Wang H, McCarthy M, Dull PM, Borrow R. Lancet. 2014 Dec 13;384(9960):2123-31. Pneumococcal serotype-specific antibodies persist through early childhood after infant immunization: follow-up from a randomized controlled trial. Trück J, Snape MD, Tatangeli F, Voysey M, Yu LM, Faust SN, Heath PT, Finn A, Pollard AJ. PLoS One. 2014 Mar 11;9(3):e91413. Predictors of immune response and reactogenicity to AS03B-adjuvanted split virion and non-adjuvanted whole virion H1N1 (2009) pandemic influenza vaccines. Andrews NJ, Walker WT, Finn A, Heath PT, Collinson AC, Pollard AJ, Snape MD, Faust SN, Waight PA, Hoschler K, Sheasby L, Waddington C, Kerridge S, Chalk J, Reiner A, John T, Fletcher M, Allen R, Fineman N, Wilkins S, Casey M, Michaelis L, Oeser C, Okike I, Ladhani S, Miller E. Vaccine. 2011 Oct 19;29(45):7913-9.
Number of competitive grants obtained in the last 5 years 8 Collaborative studies undertaken by at least 2 of the UKPVG centres.
Access to expert groups Yes European Society of Paediatric Infectious Diseases, Medicines for Children Research Network, Royal College of Paediatric and Child Health, European Medicines Agency, British Paediatric Allergy, Infection and Immunity Group, Joint Committee of Vaccination and Immunisation.
Capacity to answer external scientific questions Yes Coordinated by secretariat with email communication to UKPVG internal steering group members.
Site feasibility Yes UKPVG members assess suitability of sites available to them. Suitability will depend on study / trial.
Participant recruitment Yes Several studies currently sponsored by University of Oxford and St Georges University of London with standardised procedures for clinical trials in place, including coordination of weekly review of recruitment by Oxford site.
Budget calculation for studies Yes Budgets for commercial studies usually based on NIHR commercial costing template http://www.ukcrn.org.uk/index/industry/costing.html.