Review on the immunogenicity and safety of PCV-13 in infants and toddlers

References

• CDC. Invasive pneumococcal disease in children 5 years after conjugate vaccine introduction – eight states, 1998–2005. MMWR Morb. Mortal. Wkly Rep.57(6), 144–148 (2008).
   PubMedGoogle Scholar
• O’Brien KL, Wolfson LJ, Watt JP et al. Burden of disease caused by Streptococcus pneumoniae in children younger than 5 years: global estimates. Lancet374(9693), 893–902 (2009).
   PubMed Web of Science ®Google Scholar
• World Health Organization. Pneumococcal conjugate vaccine for childhood immunization – WHO position paper. Wkly Epidemiol. Rec.82(12), 93–104 (2007).
   PubMedGoogle Scholar
• Jodar L, Butler J, Carlone G et al. Serological criteria for evaluation and licensure of new pneumococcal conjugate vaccine formulations for use in infants. Vaccine21(23), 3265–3272 (2003).
   PubMed Web of Science ®Google Scholar
• Hausdorff WP, Bryant J, Kloek C, Paradiso PR, Siber GR. The contribution of specific pneumococcal serogroups to different disease manifestations: implications for conjugate vaccine formulation and use, part II. Clin. Infect. Dis.30(1), 122–140 (2000).
   PubMed Web of Science ®Google Scholar
• Park IH, Moore MR, Treanor JJ et al. Differential effects of pneumococcal vaccines against serotypes 6A and 6C. J. Infect. Dis.198(12), 1818–1822 (2008).
   PubMed Web of Science ®Google Scholar
• Whitney CG, Pilishvili T, Farley MM et al. Effectiveness of seven-valent pneumococcal conjugate vaccine against invasive pneumococcal disease: a matched case–control study. Lancet368(9546), 1495–1502 (2006).
   PubMed Web of Science ®Google Scholar
• Preventing pneumococcal disease among infants and young children. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm. Rep.49(RR-9), 1–35 (2000).
   PubMedGoogle Scholar
• Black S, Shinefield H, Fireman B et al. Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children. Northern California Kaiser Permanente Vaccine Study Center Group. Pediatr. Infect. Dis. J.19(3), 187–195 (2000).
   PubMed Web of Science ®Google Scholar
• Black SB, Shinefield HR, Ling S et al. Effectiveness of heptavalent pneumococcal conjugate vaccine in children younger than five years of age for prevention of pneumonia. Pediatr. Infect. Dis. J.21(9), 810–815 (2002).
   PubMed Web of Science ®Google Scholar
• Eskola J, Kilpi T, Palmu A et al. Efficacy of a pneumococcal conjugate vaccine against acute otitis media. N. Engl. J. Med.344(6), 403–409 (2001).
   PubMed Web of Science ®Google Scholar
• Klugman KP, Madhi SA, Huebner RE, Kohberger R, Mbelle N, Pierce N. A trial of a 9-valent pneumococcal conjugate vaccine in children with and those without HIV infection. N. Engl. J. Med.349(14), 1341–1348 (2003).
   PubMed Web of Science ®Google Scholar
• Cutts FT, Zaman SM, Enwere G et al. Efficacy of nine-valent pneumococcal conjugate vaccine against pneumonia and invasive pneumococcal disease in The Gambia: randomised, double-blind, placebo-controlled trial. Lancet365(9465), 1139–1146 (2005).
   PubMed Web of Science ®Google Scholar
• Klugman KP, Cutts F, Adegbola RA et al. Meta-analysis of the efficacy of conjugate vaccine against invasive pneumococcal disease. In: Pneumococcal Vaccines: the Impact of Conjugate Vaccine. Klugman KP, Makela PH, Siber GR (Eds). ASM Press, Herndon, VA, USA, 317–326 (2008).
   Google Scholar
• Pilishvili T, Lexau C, Farley MM et al. Sustained reductions in invasive pneumococcal disease in the era of conjugate vaccine. J. Infect. Dis.201(1), 32–41 (2010).
   PubMed Web of Science ®Google Scholar
• 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.348(18), 1737–1746 (2003).
   PubMed Web of Science ®Google Scholar
• Hausdorff WP, Bryant J, Paradiso PR, Siber GR. Which pneumococcal serogroups cause the most invasive disease: implications for conjugate vaccine formulation and use, part I. Clin. Infect. Dis.30(1), 100–121 (2000).
   PubMed Web of Science ®Google Scholar
• Hausdorff WP, Siber G, Paradiso PR. Geographical differences in invasive pneumococcal disease rates and serotype frequency in young children. Lancet357(9260), 950–952 (2001).
   PubMed Web of Science ®Google Scholar
• Johnson HL, Deloria-Knoll M, Levine OS et al. Systematic evaluation of serotypes causing invasive pneumococcal disease among children under five: the pneumococcal global serotype project. PLoS Med.7(10), e1000348 (2010).
   PubMed Web of Science ®Google Scholar
• CDC. Invasive pneumococcal disease in young children before licensure of 13-valent pneumococcal conjugate vaccine – United States, 2007. MMWR Morb. Mortal. Wkly Rep.59(9), 253–257 (2010).
   PubMedGoogle Scholar
• Moore MR, Gertz RE Jr, Woodbury RL et al. Population snapshot of emergent Streptococcus pneumoniae serotype 19A in the United States, 2005. J. Infect. Dis.197(7), 1016–1027 (2008).
   PubMed Web of Science ®Google Scholar
• Feavers I, Knezevic I, Powell M, Griffiths E. Challenges in the evaluation and licensing of new pneumococcal vaccines, 7–8 July 2008, Ottawa, Canada. Vaccine27(28), 3681–3688 (2009).
   PubMed Web of Science ®Google Scholar
• O’Brien KL, Moulton LH, Reid R et al. Efficacy and safety of seven-valent conjugate pneumococcal vaccine in American Indian children: group randomised trial. Lancet362(9381), 355–361 (2003).
   PubMed Web of Science ®Google Scholar
• Siber GR, Chang I, Baker S et al. Estimating the protective concentration of anti-pneumococcal capsular polysaccharide antibodies. Vaccine25(19), 3816–3826 (2007).
   PubMed Web of Science ®Google Scholar
• WHO Expert Committee on Biological Standardization. World Health Organ. Tech. Rep. Ser.927, 1–154 (2005).
   PubMed Web of Science ®Google Scholar
• Romero-Steiner S, Frasch C, Concepcion N et al. Multilaboratory evaluation of a viability assay for measurement of opsonophagocytic antibodies specific to the capsular polysaccharides of Streptococcus pneumoniae. Clin. Diagn. Lab. Immunol.10(6), 1019–1024 (2003).
   PubMedGoogle Scholar
• Quataert S, Martin D, Anderson P et al. A multi-laboratory evaluation of an enzyme-linked immunoassay quantitating human antibodies to Streptococcus pneumoniae polysaccharides. Immunol. Invest.30(3), 191–207 (2001).
   PubMed Web of Science ®Google Scholar
• Esposito S, Tansey S, Thompson A et al. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine compared to those of a 7-valent pneumococcal conjugate vaccine given as a three-dose series with routine vaccines in healthy infants and toddlers. Clin. Vaccine Immunol.17(6), 1017–1026 (2010).
   PubMed Web of Science ®Google Scholar
• Grimprel E, Laudat F, Baker S et al. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine given with routine pediatric vaccination to healthy children in France. Presented at: 27th Annual Meeting of the European Society for Paediatric Infectious Disease (ESPID). Brussels, Belgium, 9–13 June 2009.
   Google Scholar
• Kieninger DM, Kueper K, Steul K et al. Safety, tolerability, and immunologic noninferiority of a 13-valent pneumococcal conjugate vaccine compared to a 7-valent pneumococcal conjugate vaccine given with routine pediatric vaccinations in Germany. Vaccine28(25), 4192–4203 (2010).
   PubMed Web of Science ®Google Scholar
• Snape MD, Klinger CL, Daniels ED et al. 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. Pediatr. Infect. Dis. J.29(12), e80–e90 (2010).
   PubMed Web of Science ®Google Scholar
• Yeh SH, Gurtman A, Hurley DC et al. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in infants and toddlers. Pediatrics126(3), e493–e505 (2010).
   PubMed Web of Science ®Google Scholar
• Payton T, Girgenti D, Frenck R et al. Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine given with routine pediatric vaccinations in the United States. Presented at: 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14–18 March 2010.
   Google Scholar
• Kellner JD, Halperin SA, Scheifele DW et al. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in healthy infants and toddlers given with routine pediatric vaccinations in Canada. Presented at: 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14–18 March 2010.
   Google Scholar
• Bryant KA, Block SL, Baker SA, Gruber WC, Scott DA. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine. Pediatrics125(5), 866–875 (2010).
   PubMed Web of Science ®Google Scholar
• Gadzinowski J, Albrecht P, Hasiec B et al. Phase 3 trial evaluating the immunogenicity, safety, and tolerability of manufacturing scale 13-valent pneumococcal conjugate vaccine. Vaccine29(16), 2947–2955 (2011).
   PubMed Web of Science ®Google Scholar
• Payton T, Girgenti D, Frenck R et al. Safety and tolerability of 3 lots of 13-valent pneumococcal conjugate vaccine in healthy infants given with routine pediatric vaccinations in the USA. Presented at: 2nd Vaccine Global Congress. Boston, MA, USA, 7–9 December 2008.
   Google Scholar
• Gadzinowski J, Daniels ED, Giardina P et al. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine manufactured with and without ploysorbate 80 in healthy infants given at 2, 3, 4 and 12 months of age. Presented at: 27th Annual Meeting of the European Society for Paediatric Infectious Disease (ESPID). Brussels, Belgium, 9–13 June 2009.
   Google Scholar
• Martinón-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. Presented at: 28th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID). Nice, France, 4–8 May 2010.
   Google Scholar
• Grimprel E, Scott D, Laudat F, Baker S, Gruber W. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine given with routine pediatric vaccination to healthy infants in France. Presented at: 2nd Vaccine Global Congress. Boston, MA, USA, 7–9 December 2008.
   Google Scholar
• Lee HJ, Shin SH, Kim DS et al. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine given with routine pediatric vaccines in Korea. Presented at: 2nd Annual Excellence in Paediatrics Conference. London, UK, 2–4 December 2010.
   Google Scholar
• Huang LM, Lin TY, Juergens C et al. Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine given with routine vaccines to infants in Taiwan. Presented at: 13th Asian Pacific Congress of Pediatrics and 3rd Asian Pacific Congress of Pediatric Nursing. Shanghai, China, 14–18 October 2009.
   Google Scholar
• 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. Presented at: 27th Annual Meeting of the European Society for Paediatric Infectious Disease (ESPID). Brussels, Belgium, 9–13 June 2009.
   Google Scholar
• Amdekar YK, Lalwani SK, Tansey SP et al. Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in healthy infants and toddlers given with routine vaccines in India. Presented at: 48th Annual Meeting of the Infectious Diseases Society of America (IDSA). Vancouver, BC, Canada, 21–24 October 2010.
   Google Scholar
• Iwata S, Thompson A, Togashi T et al. Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in healthy infants in Japan. Presented at: 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14–18 March 2010.
   Google Scholar
• Paradiso P, Rodgers GL, Thompson A et al. Immune response to PCV13 with a reduced dosing schedule. Presented at: 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14–18 March 2010.
   Google Scholar
• Van Effelterre T, Moore MR, Fierens F et al. A dynamic model of pneumococcal infection in the United States: implications for prevention through vaccination. Vaccine28(21), 3650–3660 (2010).
   PubMed Web of Science ®Google Scholar
• Jin P, Kong F, Xiao M et al. First report of putative Streptococcus pneumoniae serotype 6D among nasopharyngeal isolates from Fijian children. J. Infect. Dis.200(9), 1375–1380 (2009).
   Google Scholar
• Park IH, Pritchard DG, Cartee R, Brandao A, Brandileone MC, Nahm MH. Discovery of a new capsular serotype (6C) within serogroup 6 of Streptococcus pneumoniae. J. Clin. Microbiol.45(4), 1225–1233 (2007).
   PubMed Web of Science ®Google Scholar
• Carvalho Mda G, Pimenta FC, Gertz RE Jr et al. PCR-based quantitation and clonal diversity of the current prevalent invasive serogroup 6 pneumococcal serotype, 6C, in the United States in 1999 and 2006 to 2007. J. Clin. Microbiol.47(3), 554–559 (2009).
   Google Scholar
• Green MC, Mason EO, Kaplan SL et al. Increase of Streptococcus pneumoniae serotype 6C at 8 children’s hospitals in the United States from 1993–2009. J. Clin. Microbiol.49(6), 2097–2101 (2011).
   PubMedGoogle Scholar
• Nahm MH, Lin J, Finkelstein JA, Pelton SI. Increase in the prevalence of the newly discovered pneumococcal serotype 6C in the nasopharynx after introduction of pneumococcal conjugate vaccine. J. Infect. Dis.199(3), 320–325 (2009).
   PubMed Web of Science ®Google Scholar
• Cooper D, Yu X, Sidhu M, Nahm MH, Fernsten P, Jansen KU. 13-valent pneumococcal conjugate vaccine elicits strong opsonophagocytic killing (OPA) activity to Streptococcus pneumoniae serotypes 6A, 6B, and 6C. Presented at: 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14–18 March 2010.
   Google Scholar
• Bryant KA, Block SL, Baker S, Scott D, ftvIS Group. Immunogenicity and safety of a toddler dose of 13-valent pneumococcal conjugate vaccine. Presented at: 6th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Reykjavik, Iceland, 8–12 June 2008.
   Google Scholar
• Esposito S, Pugni L, Bosis S et al. Immunogenicity, safety and tolerability of heptavalent pneumococcal conjugate vaccine administered at 3, 5 and 11 months post-natally to pre- and full-term infants. Vaccine23(14), 1703–1708 (2005).
   PubMed Web of Science ®Google Scholar
• Vestrheim DF, Lovoll O, Aaberge IS et al. Effectiveness of a 2+1 dose schedule pneumococcal conjugate vaccination programme on invasive pneumococcal disease among children in Norway. Vaccine26(26), 3277–3281 (2008).
   PubMed Web of Science ®Google Scholar
• van Gils EJ, Veenhoven RH, Hak E et al. Effect of reduced-dose schedules with 7-valent pneumococcal conjugate vaccine on nasopharyngeal pneumococcal carriage in children: a randomized controlled trial. JAMA302(2), 159–167 (2009).
   PubMed Web of Science ®Google Scholar
• 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. Presented at: 27th Annual Meeting of the European Society for Paediatric Infectious Disease (ESPID). Brussels, Belgium, 9–13 June 2009.
   Google Scholar
• Silfverdal SA, 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. Presented at: 28th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID). Nice, France, 4–8 May 2010.
   Google Scholar
• Frenck R, Thompson A, Yeh S et al. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in children previously immunized with 7-valent pneumococcal conjugate vaccine. Presented at: 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14–18 March 2010.
   Google Scholar
• Destefano F, Pfeifer D, Nohynek H. Safety profile of pneumococcal conjugate vaccines: systematic review of pre- and post-licensure data. Bull. World Health Organ.86(5), 373–380 (2008).
   PubMed Web of Science ®Google Scholar
• Gurtman A, Tansey SP, Thompson A et al. Safety of 13-valent pneumococcal conjugate vaccine in infants and children: meta-analysis of 13 clinical trials in 9 countries. Presented at: 28th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID). Nice, France, 4–8 May 2010.
   Google Scholar
• Black SB, Cimino CO, Hansen J et al. Immunogenicity and safety of measles–mumps–rubella, varicella and Haemophilus influenzae type b vaccines administered concurrently with a fourth dose of heptavalent pneumococcal conjugate vaccine compared with the vaccines administered without heptavalent pneumococcal conjugate vaccine. Pediatr. Infect. Dis. J.25(4), 306–311 (2006).
   Google Scholar
• Knuf M, Habermehl P, Cimino C, Petersen G, Schmitt HJ. Immunogenicity, reactogenicity and safety of a 7-valent pneumococcal conjugate vaccine (PCV7) concurrently administered with a DTPa–HBV–IPV/Hib combination vaccine in healthy infants. Vaccine24(22), 4727–4736 (2006).
   PubMedGoogle Scholar
• Schmitt HJ, Faber J, Lorenz I, Schmole-Thoma B, Ahlers N. The safety, reactogenicity and immunogenicity of a 7-valent pneumococcal conjugate vaccine (7VPnC) concurrently administered with a combination DTaP–IPV–Hib vaccine. Vaccine21(25–26), 3653–3662 (2003).
   PubMed Web of Science ®Google Scholar
• Recommendations for the prevention of Streptococcus pneumoniae infections in infants and children: use of 13-valent pneumococcal conjugate vaccine (PCV13) and pneumococcal polysaccharide vaccine (PPSV23). Pediatrics126(1), 186–190 (2010).
   PubMed Web of Science ®Google Scholar
• Nuorti JP, Whitney CG. Prevention of pneumococcal disease among infants and children – use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine – recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm. Rep.59(RR-11), 1–18 (2010).
   PubMedGoogle Scholar
• Rubin JL, McGarry LJ, Strutton DR et al. Public health and economic impact of the 13-valent pneumococcal conjugate vaccine (PCV13) in the United States. Vaccine28(48), 7634–7643 (2010).
   PubMed Web of Science ®Google Scholar
• Prymula R, Schuerman L. 10-valent pneumococcal nontypeable Haemophilus influenzae PD conjugate vaccine: Synflorix. Expert Rev. Vaccines8(11), 1479–1500 (2009).
   PubMed Web of Science ®Google Scholar
• Dagan R, Givon-Lavi N, Fraser D, Lipsitch M, Siber GR, Kohberger R. Serum serotype-specific pneumococcal anticapsular immunoglobulin G concentrations after immunization with a 9-valent conjugate pneumococcal vaccine correlate with nasopharyngeal acquisition of pneumococcus. J. Infect. Dis.192(3), 367–376 (2005).
   PubMed Web of Science ®Google Scholar
• Paradiso P, Rodgers GL, Girgenti D et al. Immunity to serogroups 6 and 19 by CRM197-based PCV7 and PCV13: the relative importance of direct and cross-protection. Presented at: 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14–18 March 2010.
   Google Scholar
• Brito MG, Girgenti D, Thompson A et al. Immunogenicity, safety, and tolerability of 13-valent pneumococcal conjugate vaccine in healthy infants given with routine pediatric vaccinations in Mexico: interim Report. Presented at: 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14–18 March 2010.
   Google Scholar