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Mildred Postigo

on 12 December 2012

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Transcript of finip

Data published in The Lancet show GlaxoSmithKline’s PCV is highly effective at preventing invasive pneumococcal disease First randomised controlled European clinical trial of a pneumococcal conjugate vaccine (PCV) to examine impact on invasive pneumococcal disease (IPD) GlaxoSmithKline's PCV is highly effective (93-100%) at preventing IPD in infants younger than 2 years of age, who are most vulnerable to infection. With 47,369 children enrolled, this is the largest IPD effectiveness trial of PCVs in children. Finnish Invasive Pneumococcal Disease Vaccine Trial (FinIP) was conducted nationwide and tracked GSK's PCV effectiveness over a two-year period on average. The results show that GSK's PCV was highly effective when administered in either a three-dose (2+1) or a four-dose (3+1) schedule to infants starting at less than seven months of age (infants received two or three doses in their first year and a booster at 2 years of age). For the first time in a clinical trial setting, effectiveness of a PCV utilised according to the infant 2+1 schedule, as used in many national immunisation programmes, was demonstrated (92% against vaccine type IPD). “IPD causes illness, hospitalisation and even death in Finnish children and across the world. These significant data show that GSK's PCV is an important public health tool in helping to reduce the burden of the disease.” Vice President and Vaccine Development Leader for Pneumococcal Vaccines, GSK Vaccines Vaccine-preventable IPD, such as meningitis, bacteraemic pneumonia and sepsis, causes death and illness in young children worldwide. The results from this randomised controlled clinical trial are also confirmed in post-implementation surveillance from four continents around the world, which show consistent robust effectiveness against IPD, following vaccination with GSK's PCV. Press Release
- IPD caused by vaccine serotypes in a 3+1 schedule was 100%.

- overall IPD, regardless of pneumococcal serotypes, was 93%. GSK's PCV effectiveness against No safety concerns were noted during the study. In addition, high effectiveness was observed in different catch-up schedules for older children. References:

i Palmu A et al. Effectiveness of the ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) against invasive pneumococcal disease: a cluster randomised trial. 2012. The Lancet.
ii World Health Organisation. Weekly epidemiological record 2012; 87:129-144.
iii DeWals P et al. Invasive pneumococcal disease in two birth cohorts vaccinated, respectively, with 2+1 PCV-7 or PHiD-CV-10 doses. ESPID 2011, The Hague, abstract 218.
iv Domingues et al. Effectiveness of one or more doses of 10-valent pneumococcal conjugate vaccine in Brazilian Children. 2012 ISPPD-8, Iguazu Falls, Brazil, 11-15th March, abstract # 764.
v Liphaus et al. Impact of 10-valent pneumococcal conjugate vaccine routine immunization schedule in incidence of pneumococcal meningitis in the state of Sao Paulo. 2012 ISPPD-8, Iguazu Falls, Brazil, 11-15th March, abstract # 736.
vi Scott et al. Impact of Introduction of 10-valent pneumococcal conjugate vaccine in Kenya on invasive pneumococcal disease among children under 5 years. 2012, ISPPD-8, Iguazu Falls, Brazil, 11-15th March, abstract # 211.
vii Kilifi health and demographic surveillance system PCVIS: the pneumococcal conjugate vaccine impact study. http://www.kemri-wellcome.org/pcvis-current%20disease%20surveillance. Accessed 13 November 2012.
viii Jokinen et al. 2012, Monitoring the effectiveness of the 10-valent pneumococcal conjugate vaccine (PCV10) in the the Finnish national vaccination programme (NVP). http://www.ktl.fi/attachments/suomi/osastot/roko/roto/isppd8_pneumokokkivaik_englanti_posteri.pdf. Accessed 13 November 2012.
ix Santos et al. Impact of the ten valent pneumococcal conjugated vaccine on pneumococcal infection of the population attending university hospital in Brazil. 2012 ICAAC, San Francisco, USA, 9-12th Sept.
x Afonso et al. Pneumococcal Vaccine Introduction in Brazil: A Preliminary Impact Analysis. 2012, ISPPD-8, Iguazu Falls, Brazil, 13-15th March.
xi GSK Biologicals. Synflorix™ EU Summary of Product Characteristics, 2011.
xii Synflorix Philippine Country Prescribing Information Version number: GDS004/IPI05 / Date of issue: 28/02/2011 GSK's PCV Local Indication:
Active immunisation of infants and children from 6 weeks up to 5 years of age against disease caused by Streptococcus pneumoniae serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media) and against acute otitis media caused by Non-Typeable Haemophilus influenzae. Globally, IPD kills a child under five years of age every 40 seconds, with the majority of these living in the poorest countries, causing up to half a million deaths every year. Thank you
for your attention!
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