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Pneumococcal Polysaccharide Conjugate Vaccine (13-Valent, Adsorbed) [Prevenar 13®]

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Table I

References

  1. O’Brien KL, Wolfson LJ, Watt JP, et al. Burden of disease caused by Streptococcus pneumoniae in children younger than 5 years: global estimates. Lancet 2009 Sep 12; 374(9693): 893–902

    Article  PubMed  Google Scholar 

  2. World Health Organization. Acute respiratory infections (update Sep 2009) [online]. Available from URL: http://www.who.int/vaccine_research/diseases/ari/en/print.html [Accessed 2010 May 13]

  3. European Medicines Agency. Assessment report for Prevenar 13 [online]. Available from URL: http://www.ema.europa.eu/humandocs/PDFs/EPAR/Prevenar13/H-1104-en6.pdf [Accessed 2010 Apr 6]

  4. Hausdorff WP, Bryant J, Paradiso PR, et al. Which pneumococcal serogroups cause the most invasive disease: implications for conjugate vaccine formulation and use, part I. Clin Infect Dis 2000 Jan; 30(1): 100–21

    Article  PubMed  CAS  Google Scholar 

  5. Henrichsen J. Typing of Streptococcus pneumoniae: past, present, and future. Am J Med 1999 Jul 26; 107(1A): 50–54S

    Article  Google Scholar 

  6. Ardanuy C, Fenoll A, Rolo D, et al. Characterization of serotype 5 pneumococci causing an outbreak of invasive pneumococcal disease (IPD) in 2005 in Barcelona, Spain. 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy; 2008 Oct 25–28; Washington, DC

  7. Cohen R, Levy C, de La Rocque F, et al. Impact of pneumococcal conjugate vaccine and of reduction of antibiotic use on nasopharyngeal carriage of nonsusceptible pneumococci in children with acute otitis media. Pediatr Infect Dis J 2006 Nov;25(11): 1001–7

    Article  PubMed  Google Scholar 

  8. Whitney CG, Farley MM, Hadler J, et al. Decline in invasive pneumococcal disease after the introduction of protein-polysaccharide conjugate vaccine. N Engl J Med 2003 May 1; 348(18): 1737–46

    Article  PubMed  Google Scholar 

  9. Millar EV, Watt JP, Bronsdon MA, et al. Indirect effect of 7-valent pneumococcal conjugate vaccine on pneumococcal colonization among un vaccinated household members. Clin Infect Dis 2008 Oct 15; 47(8): 989–96

    Article  PubMed  Google Scholar 

  10. Isaacman DJ, Fletcher MA, Fritzell B, et al. Indirect effects associated with widespread vaccination of infants with heptavalent pneumococcal conjugate vaccine (PCV7; Prevnar). Vaccine 2007 Mar 22; 25(13): 2420–7

    Article  PubMed  Google Scholar 

  11. Hicks LA, Harrison LH, Flannery B, et al. Incidence of pneumococcal disease due to non-pneumococcal conjugate vaccine (PCV7) serotypes in the United States during the era of widespread PCV7 vaccination, 1998–2004. J Infect Dis 2007 Nov 1; 196(9): 1346–54

    Article  PubMed  Google Scholar 

  12. Hsu HE, Shutt KA, Moore MR, et al. Effect of pneumococcal conjugate vaccine on pneumococcal meningitis. N Engl J Med 2009 Jan 15; 360(3): 244–56

    Article  PubMed  CAS  Google Scholar 

  13. Nuorti P, Rosen J, Thomas A. Invasive pneumococcal disease in young children caused by serotypes in the new 13-valent conjugate vaccine: implications for immunization strategies [abstract no. G1-1554]. 49th Interscience Conference on Antimicrobial Agents and Chemotherapy; 2009 Sep 12–15; San Francisco (CA)

  14. Black S. The volatile nature of pneumococcal serotype epidemiology: potential for misinterpretation. Pediatr Infect Dis J 2010 Apr; 29(4): 301–3

    PubMed  Google Scholar 

  15. O’Brien KL, Dagan R. The potential indirect effect of conjugate pneumococcal vaccines. Vaccine 2003 May 16; 21(17–18): 1815–25

    Article  PubMed  Google Scholar 

  16. Wyeth Pharmaceuticals. Prevenar 13 suspension for injection; pneumococcal polyscaccharide conjugate (13-valent, adsorbed): summary of product characteristics [online]. Available from URL: http://www.medicines.org.uk/emc/document.aspx?documentid=22689&doctype=SPC [Accessed 2010 Apr 6]

  17. Wyeth Pharmaceuticals Inc. Prevenar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]): suspension for intramuscular injection [online]. Available from URL: http://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm201669.pdf [Accessed 2010 Jun 12]

  18. Duggan ST. Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed) [prevenar 13®]. Drugs 2010 Oct; 70(15): 1973–86

    Article  PubMed  CAS  Google Scholar 

  19. Esposito S, Tansey S, Thompson A, et al. Safety and immunogenicity of 13-valent pneumococcal conjugate vaccine compared to 7-valent pneumococcal conjugate vaccine given as a 3-dose series with routine vaccines in healthy infants and toddlers. Clin Vaccine Immunol 2010; 17(6): 1017–26

    Article  PubMed  CAS  Google Scholar 

  20. Martinon-Torres F, Gimenez-Sanchez F, Gurtman A, et al. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine given with meningococcal C tetanus toxoid conjugate and other routine pediatric vaccinations [poster]. 28th Annual Meeting of the European Society for Paediatric Infectious Diseases; 2010 May 4–8; Nice

  21. Diez-Domingo J, Gurtman A, Bernaola E, et al. Safety and immunogenicity of 13-valent pneumococcal conjugate vaccine in healthy infants and toddlers receiving routine vaccinations in Spain. 27 th Annual Meeting of the European Society for Paediatric Infectious Diseases; 2009 Jun 9–13; Brussels

  22. Hughes JY, Snape CL, Klinger CL, et al. Immunogenicity of booster doses of 13-valent pneumococcal conjugate and HIB/MENC vaccines given at12 months of age in the UK. 27 th Annual Meeting of the European Society for Paediatric Infectious Diseases; 2009 Jun 9–13; Brussels

  23. Klinger CL, Snape MD, John T, et al. Immunogenicity of DTaP-IPV-Hib and menC vaccines in the UK when administered with a 13-valent pneumococcal conjugate vaccine [abstract no. GI-2118]. 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy and 46th Annual Meeting of the Infectious Diseases Society of America; a joint meeting; 2008 Oct 25–28; Washington, DC: 367

  24. Kieninger DM, Kueper K, Steul K, et al. Safety, tolerability and immunologic noninferiority of 13-valent pneumococcal conjugate vaccine compared to 7-valent pneumococcal conjugate vaccine given with routine pediatric vaccinations in Germany. Vaccine 2010; 28(25): 4192–203

    Article  PubMed  CAS  Google Scholar 

  25. Gadzinowski J, Tansey S, Mellelieu T, et al. A phase 3 trial evaluating the safety, tolerability and immunogenicity of manufacturing scale 13-valent pneumococcal conjugate vaccine [abstract no. GI-2116]. 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy and 46th Annual Meeting of the Infectious Diseases Society of America: a joint meeting; 2008 Oct 25–28; Washington, DC

  26. Grimprel E, Laudat F, Baker SA, et al. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine given with routine pediatric vaccination to healthy children in France. 27th Annual Meeting of the European Society for Paediatric Infectious Diseases; 2009 Jun 9–13; Brussels

  27. Grimprel E, Scott D, Laudat F, et al. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine given with routine pediatric vacination to healthy infants in France [abstract no. GI-2119]. 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy and 46th Annual Meeting of the Infectious Diseases Society of America: a joint meeting; 2008 Oct 25–28; Washington, DC

  28. Gadzinowski J, Daniels E, Scott DA, et al. Safety and immunogenicity of 13-valent pneumococcal conjugate vaccine with/without polysorbate 80 in healthy infants in Poland. 27th Annual Meeting of the European Society for Paediatric Infectious Diseases; 2009 Jun 9–13; Brussels

  29. Silfverdal AV, Tansey SP, Skoglund G, et al. Phase 3, open-label trial of 13-valent pneumococcal conjugate vaccine as a toddler dose in healthy children previously partially immunized with 7-valent pneumococcal conjugate vaccine [poster]. 28th Annual Meeting of the European Society for Paediatric Infectious Diseases; 2010 May 4–8; Nice

  30. Wysocki J, Daniels ED, Sarkozy DA, et al. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine administered to older infants and children naive to previous vaccination. 27 th Annual Meeting of the European Society for Paediatric Infectious Diseases; 2009 Jun 9–13; Brussels

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Acknowledgments and Disclosures

The full-text article[18] from which this profile report was derived was reviewed by: L. Lee, Center for Biologics Evaluation and Research, US Food and Drug Administration, Bethesda, MD, USA; S. Obaro, Department of Pediatrics and Human Development, Michigan State University, East Lansing, MI, USA; R. Prymula, Faculty of Military Health Sciences, University of Defence, Hradec Kralove, Czech Republic.

The manufacturer of the agent under review was offered an opportunity to comment on the original article[18] during the peer review process. Changes based on any comments received were made by the author on the basis of scientific and editorial merit. The preparation of the original article and this profile report was not supported by any external funding.

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Correspondence to Sean T. Duggan.

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Adapted and reproduced from the original article published in Drugs 2010; 70 (15): 1973–86.

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Duggan, S.T. Pneumococcal Polysaccharide Conjugate Vaccine (13-Valent, Adsorbed) [Prevenar 13®]. Pediatr Drugs 14, 67–69 (2012). https://doi.org/10.2165/11207010-000000000-00000

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