The 13-valent pneumococcal conjugate vaccine for invasive pneumococcal disease in alaska native children: Results of a clinical trial

Pediatric Infectious Disease Journal

Volumn 32, Issue 3, 2013, Pages 257-263

  Singleton, Rosalyn ^a,b   Wenger, Jay ^b   Klejka, Joseph A ^c   Bulkow, Lisa R ^b   Thompson, Allison ^d   Sarkozy, Denise ^e   Emini, Emilio A ^f   Gruber, William C ^d   Scott, Daniel A ^d  

^a NATIONAL CENTER FOR EMERGING AND ZOONOTIC INFECTIOUS DISEASES   (United States)

^b NATL CENTER FOR INFECTIOUS DISEASES   (United States)

^c Yukon Kuskokwim Health Corporation   (United States)

^d Pfrzer Inc   (United States)

^e PFIZER INC   (United States)

^f Pfrzer Inc   (United States)

Author keywords

Alaska Native; Children; Invasive pneumococcal disease; Pneumococcal conjugate vaccine

Indexed keywords

IMMUNOGLOBULIN G; PNEUMOCOCCUS VACCINE;

ABSCESS; ANEMIA; APNEA; ARTICLE; ASTHMA; BACTEREMIA; BACTERIAL ARTHRITIS; BRONCHIOLITIS; DECREASED APPETITE; DEHYDRATION; DRUG ERUPTION; DRUG FEVER; DRUG SAFETY; ECZEMA; ESOPHAGUS FOREIGN BODY; GASTROENTERITIS; GASTROESOPHAGEAL REFLUX; HAEMOPHILUS MENINGITIS; HERPANGINA; HUMAN; HYPONATREMIA; IMMUNOGENICITY; INFLUENZA; INJECTION SITE SWELLING; IRRITABILITY; LARYNGOMALACIA; LYMPHADENITIS; MACULOPAPULAR RASH; PHASE 3 CLINICAL TRIAL (TOPIC); PNEUMOCOCCAL INFECTION; PNEUMONIA; PRIORITY JOURNAL; RESPIRATORY DISTRESS; RESPIRATORY FAILURE; SEIZURE; SIDE EFFECT; SKIN REDNESS; SLEEP DISORDER; SUDDEN INFANT DEATH SYNDROME; TRACHEOBRONCHITIS; UNITED STATES; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; URTICARIA; VACCINATION; VIRUS MENINGITIS;

ALASKA; ANTIBODIES, BACTERIAL; CHILD, PRESCHOOL; DRUG TOXICITY; FEMALE; HUMANS; IMMUNOGLOBULIN G; INCIDENCE; INFANT; MALE; MENINGITIS, PNEUMOCOCCAL; PNEUMOCOCCAL INFECTIONS; PNEUMOCOCCAL VACCINES; SEPSIS;

EID: 84876205452     PISSN: 08913668     EISSN: 15320987     Source Type: Journal    
DOI: 10.1097/INF.0b013e3182748ada     Document Type: Article

References (31)

1. State of Alaska Department of Labor and Workforce Development. Population estimates, 2008. Available at: http://almis.labor.state.ak.us/?PAGEID= 67&SUBID=115. Accessed March 15, 2011.
2. Rudolph KM, Parkinson AJ, Reasonover AL, et al. Serotype distribution and antimicrobial resistance patterns of invasive isolates of Streptococcus pneumoniae: Alaska, 1991-1998. J Infect Dis. 2000;182:490-496.
3. Davidson M, Parkinson AJ, Bulkow LR, et al. The epidemiology of invasive pneumococcal disease in Alaska, 1986-1990-ethnic differences and opportunities for prevention. J Infect Dis. 1994;170:368-376.
4. Wenger JD, Zulz T, Brüden D, et al. Invasive pneumococcal disease in Alaskan children: impact of the seven-valent pneumococcal conjugate vaccine and the role of water supply. Pediatr Infect Dis J. 2010;29:251-256.
5. Centers for Disease Control and Prevention (CDC). Invasive pneumococcal disease in children 5 years after conjugate vaccine introduction-eight states, 1998-2005. MMWR Morb Mortal Wkly Rep. 2008;57:144-148.
6. Singleton RJ, Hennessy TW, Bulkow LR, et al. Invasive pneumococcal disease caused by nonvaccine serotypes among alaska native children with high levels of 7-valent pneumococcal conjugate vaccine coverage. JAMA. 2007;297:1784-1792.
7. Scott DA, Komjathy SF, Hu BT, et al. Phase 1 trial of a 13-valent pneumococcal conjugate vaccine in healthy adults. Vaccine. 2007;25:6164-6166.
8. Scott D, Ruckle J, Dar M, et al. Phase 1 trial of 13-valent pneumococcal conjugate vaccine in Japanese adults. Pediatr Int. 2008;50:295-299.
9. Bryant KA, Block SL, Baker SA, et al.; PCV13 Infant Study Group. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine. Pediatrics. 2010;125:866-875.
10. Yeh SH, Gurtman A, Hurley DC, et al.; 004 Study Group. Immunogenic ity and safety of 13-valent pneumococcal conjugate vaccine in infants and toddlers. Pediatrics. 2010;126:e493-e505.
11. 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;28:4192-4203.
12. Snape MD, Klinger CL, Daniels ED, et al. Immunogenic ity 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. 2010;29:e80-e90.
13. 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. 2010;17:1017-1026.
14. Vanderkooi OG, Scheifele DW, Girgenti D, et al.; Canadian PCV13 Study Group. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine in healthy infants and toddlers given with routine pediatric vaccinations in Canada. Pediatr Infect Dis J. 2012;31:72-77.
15. Hennessy TW, Ritter T, Holman RC, et al. The relationship between in-home water service and the risk of respiratory tract, skin, and gastrointestinal tract infections among rural Alaska natives. Am J Public Health. 2008;98:2072-2078.
16. Nuorti JP, Whitney CG; Centers for Disease Control and Prevention (CDC). 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. 2010;59(RR-11):1-18.
17. Centers for Disease Control and Prevention (CDC). Licensure of a 13-valent pneumococcal conjugate vaccine (PCV13) and recommendations for use among children - Advisory Committee on Immunization Practices (ACIP), 2010. MMWR Morb Mortal Wkly Rep. 2010;59:258-261.
18. 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. Vaccine. 2010;28:7634-7643.
19. 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.
20. Hu BT, Yu X, Jones TR, et al. Approach to validating an opsonophago-cytic assay for Streptococcus pneumoniae. Clin Diagn Lab Immunol. 2005;12:287-295.
21. World Health Organization. Recommendations for the Production and Control of Pneumococcal Conjugate Vaccines. Annex 2. Geneva, Switzerland: World Health Organization; 2005.
22. Rothman KJ. Modern Epidemiology. Boston, MA: Little, Brown and Company; 1986.
23. De Serres G, Pilishvili T, Link-Gelles R, et al. Use of surveillance data to estimate the effectiveness of the 7-valent conjugate pneumococcal vaccine in children less than 5 years of age over a 9 year period. Vaccine. 2012;30:4067-4072.
24. 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;29:7207-7211.
25. Hanage WP, Finkelstein JA, Huang SS, et al. Evidence that pneumococcal serotype replacement in Massachusetts following conjugate vaccination is now complete. Epidemics. 2010;2:80-84.
26. 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. 2008;197:1016-1027.
27. Feikin DR, Klugman KP Historical changes in pneumococcal serogroup distribution: implications for the era of pneumococcal conjugate vaccines. Clin Infect Dis. 2002;35:547-555.
28. Brueggemann AB, Griffiths DT, Meats E, et al. Clonal relationships between invasive and carriage Streptococcus pneumoniae and serotype-and clone-specific differences in invasive disease potential. J Infect Dis. 2003;187:1424-1432.
29. Pilishvili T, Zell ER, Farley MM, et al. Risk factors for invasive pneumococcal disease in children in the era of conjugate vaccine use. Pediatrics. 2010;126:e9-e17.
30. Weinberger DM, Malley R, Lipsitch M. Serotype replacement in disease after pneumococcal vaccination. Lancet. 2011;378:1962-1973.
31. Singleton RJ, Brüden D, Bulkow LR. Respiratory syncytial virus season and hospitalizatons in the Alaskan Yukon-Kuskokwim Delta. Pediatr Infect Dis J. 2007;26:S46-S50.