13-valent pneumococcal conjugate vaccine in older children and adolescents either previously immunized with or naïve to 7-valent pneumococcal conjugate vaccine

Pediatric Infectious Disease Journal

Volumn 33, Issue 2, 2014, Pages 183-189

  Frenck, Robert ^a   Thompson, Allison ^b   Senders, Shelly ^c   Harris Ford, Laurie ^d   Sperling, Malcolm ^e   Patterson, Scott ^b   Devlin, Carmel ^b   Jansen, Kathrin U ^b   Gruber, William C ^b   Emini, Emilio A ^b   Scott, Daniel A ^b   Gurtman, Alejandra ^b  

^a CINCINNATI CHILDREN'S HOSPITAL MEDICAL CENTER   (United States)

^b PFIZER INC   (United States)

^c Senders Pediatrics   (United States)

^d Alpha Clinical Research   (United States)

^e Edinger Medical Group   (United States)

Author keywords

13 valent pneumococcal conjugate vaccine; adolescents; children; immunogenicity; safety

Indexed keywords

IMMUNOGLOBULIN G; PNEUMOCOCCUS VACCINE;

ADOLESCENT; ARTICLE; CHILD; CLINICAL ARTICLE; COUGHING; DECREASED APPETITE; DRUG FEVER; DRUG INDUCED HEADACHE; FEMALE; GROUPS BY AGE; HUMAN; IMMUNOGENICITY; INFLUENZA; INJECTION SITE REACTION; INJECTION SITE SWELLING; MALE; MULTICENTER STUDY; OPEN STUDY; OROPHARYNX PAIN; PHARYNGITIS; PHASE 3 CLINICAL TRIAL; PRESCHOOL CHILD; PRIORITY JOURNAL; PROSPECTIVE STUDY; SCHOOL CHILD; SEROTYPE; SINUSITIS; SLEEP DISORDER; STREPTOCOCCAL PHARYNGITIS; SWELLING; URTICARIA; VOMITING;

ADOLESCENT; AGE FACTORS; CHILD; CHILD, PRESCHOOL; FEMALE; HUMANS; INFANT; MALE; PNEUMOCOCCAL INFECTIONS; PNEUMOCOCCAL VACCINES; PROSPECTIVE STUDIES; STREPTOCOCCUS PNEUMONIAE; UNITED STATES; VACCINES, CONJUGATE;

EID: 84892955220     PISSN: 08913668     EISSN: 15320987     Source Type: Journal    
DOI: 10.1097/INF.0000000000000056     Document Type: Article

References (29)

1. Pilishvili T, Lexau C, Farley MM, et al.; Active Bacterial Core Surveillance Emerging Infections Program Network. Sustained reductions in invasive pneumococcal disease in the era of conjugate vaccine. J Infect Dis. 2010;20132-41
2. Whitney CG, Farley MM, Hadler J, et al.; Active Bacterial Core Surveillance of the Emerging Infections Program Network. Decline in invasive pneumococcal disease after the introduction of protein-polysaccharide conjugate vaccine. N Engl J Med. 2003;3481737-1746
3. Vestrheim DF, Løvoll O, Aaberge IS, et al. Effectiveness of a 2+1 dose schedule pneumococcal conjugate vaccination programme on invasive pneumococcal disease among children in Norway. Vaccine. 2008;26 3277-3281
4. Grall N, Hurmic O, Al Nakib M, et al.; ORP Ile de France Ouest. Epidemiology of Streptococcus pneumoniae in France before introduction of the PCV-13 vaccine. Eur J Clin Microbiol Infect Dis. 2011;301511-1519
5. Nuorti JP, Whitney CG; Centers for Disease Control and Prevention (CDC).Prevention of pneumococcal disease among infants and children - use of13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine - recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2010;59 (RR-11)1-18
6. U.S. Department of Health & Human Services. U.S. Food and Drug Administration. Vaccines, blood, & biologics. Approval letter - Prevnar 13.January 25, 2013. Available at httpwww.fda.govBiologicsBloodVaccines VaccinesApprovedProductsucm337170.htm. Accessed May 13, 2013
7. European Medicines Agency. Summary of opinion (post authorisation). Prevenar 13 pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed); EMACHMP7170802012. Available at httpwww.ema. europa.eudocsen GBdocument librarySummary of opinion human001104WC500134840.pdf. Accessed May 13, 2013
8. Committee on Infectious Diseases. Recommended childhood and adolescent immunization schedules - United States, 2012. Pediatrics. 2012;129 385-386
9. Frenck R Jr, Thompson A, Yeh SH, et al.; 3011 Study Group. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in children previously immunized with 7-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2011;301086-1091
10. Talbot TR, Hartert TV, Mitchel E, et al. Asthma as a risk factor for invasive pneumococcal disease. N Engl J Med. 2005;3522082-2090
11. 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. 2001;30 191-207
12. Quataert SA, Rittenhouse-Olson K, Kirch CS, et al. Assignment of weightbased antibody units for 13 serotypes to a human antipneumococcal standard reference serum, lot 89-S(f). Clin Diagn Lab Immunol. 2004;11 1064-1069
13. Baker S, Hu BT, Hackell J, et al. Effect of addition of heterologous pneumococcal polysaccharide 22F to the WyethWHO pneumococcal polysaccharide ELISA on IgG assignments for infant sera. Presented at the 5th International Symposium on Pneumococci and Pneumococcal Diseases; April 2-6, 2006; Alice Springs, NT, Australia. Abstract 285
14. Siber GR, Chang I, Baker S, et al. Estimating the protective concentration of anti-pneumococcal capsular polysaccharide antibodies. Vaccine. 2007;253816-3826
15. Wernette CM, Frasch CE, Madore D, et al. Enzyme-linked immunosorbent assay for quantitation of human antibodies to pneumococcal polysaccharides. Clin Diagn Lab Immunol. 2003;10514-519
16. Liu X, Wang S, Sendi L, Caulfield MJ. High-throughput imaging of bacterial colonies grown on filter plates with application to serum bactericidal assays. J Immunol Methods. 2004;292187-193
17. Cooper D, Yu X, Sidhu M, et al. The 13-valent pneumococcal conjugate vaccine (PCV13) elicits cross-functional opsonophagocytic killing responses in humans to Streptococcus pneumoniae serotypes 6C and 7A. Vaccine. 2011;297207-7211
18. Payton T, Girgenti D, Frenck RW, et al. Immunogenicity, safety, and tolerability of three lots of 13-valent pneumococcal conjugate vaccine given with routine pediatric vaccinations in the United States. Pediatr Infect Dis J. 2013, 32;871-880
19. 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. 2000;19187-195
20. Eskola J, Kilpi T, Palmu A, et al.; Finnish Otitis Media Study Group. Efficacy of a pneumococcal conjugate vaccine against acute otitis media. N Engl J Med. 2001;344403-409
21. Black S, France EK, Isaacman D, et al. Surveillance for invasive pneumococcal disease during 2000-2005 in a population of children who received 7-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2007;26771-777
22. 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. 2002;21810-815
23. Hansen J, Black S, Shinefield H, et al. Effectiveness of heptavalent pneumococcal conjugate vaccine in children younger than 5 years of age for prevention of pneumonia updated analysis using World Health Organization standardized interpretation of chest radiographs. Pediatr Infect Dis J. 2006;25779-781
24. Yeh SH, Gurtman A, Hurley DC, et al.; 004 Study Group. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in infants and toddlers. Pediatrics. 2010;126e493-e505
25. Kieninger DM, Kueper K, Steul K, et al.; 006 study group. 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. Vaccine. 2010;284192-4203
26. Miller E, Andrews NJ, Waight PA, et al. Effectiveness of the new serotypes in the 13-valent pneumococcal conjugate vaccine. Vaccine. 2011;29 9127-9131
27. Cohen R, Levy C, Bingen E, et al. Impact of 13-valent pneumococcal conjugate vaccine on pneumococcal nasopharyngeal carriage in children with acute otitis media. Pediatr Infect Dis J. 2012;31297-301
28. Kaplan SL, Mason EO Jr, Barson WJ, et al. Three-year multicenter surveillance of systemic pneumococcal infections in children. Pediatrics. 1998;102(3 pt 1)538-545
29. Simonsen L, Taylor RJ, Young-Xu Y, et al. Impact of pneumococcal conjugate vaccination of infants on pneumonia and influenza hospitalization and mortality in all age groups in the United States. MBio. 2011;2e00309-e00310