Safety profile of pneumococcal conjugate vaccines: Systematic review of pre- and post-licensure data

Bulletin of the World Health Organization

Volumn 86, Issue 5, 2008, Pages 373-380

  DeStefano, Frank ^a   Pfeifer, Dina ^b   Nohynek, Hanna ^c  

^a RTI INTERNATIONAL   (United States)

^b WORLD HEALTH ORGANIZATION   (Switzerland)

^c NATIONAL PUBLIC HEALTH INSTITUTE   (Finland)

Author keywords

[No Author keywords available]

Indexed keywords

DIPHTHERIA PERTUSSIS TETANUS VACCINE; HEPATITIS B VACCINE; MENINGITIS VACCINE; PNEUMOCOCCUS VACCINE;

ASTHMA; BACTERIUM; CHILD HEALTH; HEALTH RISK; POLYSACCHARIDE; PROTEIN; SAFETY; VACCINATION; VACCINE;

AGITATION; ARTICLE; ASTHMA; CLINICAL TRIAL; DRUG APPROVAL; DRUG SAFETY; FEVER; HOSPITALIZATION; HUMAN; INJECTION SITE ERYTHEMA; INJECTION SITE REACTION; INJECTION SITE SWELLING; IRRITABILITY; PNEUMONIA; POSTMARKETING SURVEILLANCE; PREMATURITY; SIDE EFFECT; SYSTEMATIC REVIEW; UNITED STATES;

AGE FACTORS; AIDS-RELATED OPPORTUNISTIC INFECTIONS; CHILD, PRESCHOOL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; HUMANS; INFANT; PNEUMOCOCCAL VACCINES; PNEUMONIA, PNEUMOCOCCAL; PRODUCT SURVEILLANCE, POSTMARKETING; VACCINES, CONJUGATE; WORLD HEALTH ORGANIZATION;

NORTH AMERICA; UNITED STATES;

EID: 43749086880     PISSN: 00429686     EISSN: 15640604     Source Type: Journal    
DOI: 10.2471/BLT.07.048025     Document Type: Article

References (51)

1. Pneumococcal vaccines accelerated development and introduction plan (pneumoADIP). Available from: http://www.preventpneumo.org [accessed on 25 March 2008].
2. Global Advisory Committee on Vaccine Safety. 29-30 November 2006. Wkly Epidemiol Rec 2007;82:18-24.
3. Clinical review of new product license application (PLA 92-0279), Prevnar seven valent pneumococcal conjugate vaccine. US Food and Drug Administration (FDA); February 2000. Available from: http://www.fda.gov/cber/products/prevnar. htm [accessed on 25 March 2008].
4. Clinical review of amendment to product license application (STN# 103905 10031). US Food and Drug Administration (FDA); June 2005. Available from: http://www.fda.gov/cber/review/pneuled100102r.pdf [accessed on 25 March 2008].
5. Black S, Shinefield H, Fireman B, Lewis E, Ray P, Hansen JR, 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;19:187-95.
6. Eskola J, Kilpi T, Palmu A, Jokinen J, Haapakoski J, Herva E, et al.; Finnish Otitis Media Study Group. Efficacy of a pneumococcal conjugate vaccine against acute otitis media. N Engl J Med 2001;344:403-9.
7. Wise RP, Iskander J, Pratt RD, Campbell S, Ball R, Pless RP, et al. Postlicensure safety surveillance for 7-valent pneumococcal conjugate vaccine. JAMA 2004;292:1702-10.
8. Addressing concerns regarding immunization and vaccines: questions, answers and issues. Division of Immunization, Laboratory Centre for Disease Control, Health Canada; 1996. Available from: http://www.hc-sc.gc.ca/hpb/lcdc/ bid/di/mscn_6f.html [accessed on 25 March 2008].
9. Choo S, Seymour L, Morris R, Quataert S, Lockhart S, Cartwright K, et al. Immunogenicity and reactogenicity of a pneumococcal conjugate vaccine administered combined with a Haemophilus influenzae type B conjugate vaccine in United Kingdom infants. Pediatr Infect Dis J 2000;19:854-62.
10. Rennels MB, Edwards KM, Keyserling HL, Reisinger KS, Hogerman DA, Madore DV, et al. Safety and immunogenicity of heptavalent pneumococcal vaccine conjugated to CRM197 in United States infants. Pediatrics 1998;101:604-11.
11. Shinefield HR, Black S, Ray P, Chang I, Lewis N, Fireman B, et al. Safety and immunogenicity of heptavalent pneumococcal CRM197 conjugate vaccine in infants and toddlers. Pediatr Infect Dis J 1999;18:757-63.
12. 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. Vaccine 2006;24:4727-36.
13. Scheifele DW, Halperin SA, Smith B, Ochnio J, Meloff K, Duarte-Monteiro D. Assessment of the compatibility of co-administered 7-valent pneumococcal conjugate, DTaP.IPV/PRP-T Hib and hepatitis B vaccines in infants 2-7 months of age. Vaccine 2006;24:2057-64.
14. Schmitt HJ, Faber J, Lorenz I, Schmöle-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. Vaccine 2003;21:3653-62.
15. Tichmann-Schumann I, Soemantri P, Behre U, Disselhoff J, Mahler H, Maechler G, et al. Immunogenicity and reactogenicity of four doses of diphtheria-tetanus-three-component acellular pertussis-hepatitis B-inactivated polio virus-Haemophilus influenzae type b vaccine coadministered with 7-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J 2005;24:70-7.
16. Käyhty H, Ahman H, Eriksson K, Sörberg M, Nilsson L. Immunogenicity and tolerability of a heptavalent pneumococcal conjugate vaccine administered at 3, 5 and 12 months of age. Pediatr Infect Dis J 2005;24:108-14.
17. Shao PL, Lu CY, Chang LY, Huang FY, Lee CY, Hsueh PR, et al. Safety and immunogenicity of heptavalent pneumococcal conjugate vaccine booster in Taiwanese toddlers. J Formos Med Assoc 2006;105:542-9.
18. Shao PL, Lu CY, Chang LY, Huang FY, Wang CY, Yang CY, et al. Safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in Taiwanese infants. J Formos Med Assoc 2004;103:613-7.
19. de Arístegui Fernández J, Cos Arregui B, Zurimendi Carril A, Alday Esteban MV, Alzua Ruiz J, De la Fuente Jausoro E, et al. Evaluation of the safety and immunogenicity of pneumococcal seven-valent conjugate vaccine (Prevenar) administered in previously unvaccinated Spanish children aged 24 to 36 months. Vaccine 2005;23:1917-22.
20. Obaro SK, Adegbola RA, Chang I, Banya WA, Jaffar S, Mcadam KW, et al. Safety and immunogenicity of a nonavalent pneumococcal vaccine conjugated to CRM197 administered simultaneously but in a separate syringe with diphtheria, tetanus and pertussis vaccines in Gambian infants. Pediatr Infect Dis J 2000;19:463-9.
21. Capeding MZ, Puumalainen T, Gepanayao CP, Kayhty H, Lucero MG, Nohynek H. Safety and immunogenicity of three doses of an eleven-valent diphtheria toxoid and tetanus protein-conjugated pneumococcal vaccine in Filipino infants. BMC Infect Dis 2003;3:17.
22. Nachman S, Kim S, King J, Abrams EJ, Margolis D, Petru A, et al.; Pediatric AIDS Clinical Trials Group Study 292 Team. Safety and immunogenicity of a heptavalent pneumococcal conjugate vaccine in infants with human immunodeficiency virus type 1 infection. Pediatrics 2003;112:66-73.
23. O'Brien KL, Swift AJ, Winkelstein JA, Santosham M, Stover B, Luddy R, et al. Safety and immunogenicity of heptavalent pneumococcal vaccine conjugated to CRM(197) among infants with sickle-cell disease. Pneumococcal Conjugate Vaccine Study Group. Pediatrics 2000;106:965-72.
24. Sigurdardottir ST, Ingolfsdottir G, Davidsdottir K, Gudnason T, Kjartansson S, Kristinsson KG, et al. Immune response to octavalent diphtheria- and tetanusconjugated pneumococcal vaccines is serotype- and carrier-specific: the choice for a mixed carrier vaccine. Pediatr Infect Dis J 2002;21:548-54.
25. Anderson EL, Kennedy DJ, Geldmacher KM, Donnelly J, Mendelman PM. Immunogenicity of heptavalent pneumococcal conjugate vaccine in infants. J Pediatr 1996;128:649-53.
26. Blum MD, Dagan R, Mendelman PM, Pinsk V, Giordani M, Li S, et al. A comparison of multiple regimens of pneumococcal polysaccharide-meningococcal outer membrane protein complex conjugate vaccine and pneumococcal polysaccharide vaccine in toddlers. Vaccine 2000;18:2359-67.
27. Nurkka A, Joensuu J, Henckaerts I, Peeters P, Poolman J, Kilpi T, et al. Immunogenicity and safety of the eleven valent pneumococcal polysaccharide- protein D conjugate vaccine in infants. Pediatr Infect Dis J 2004;23:1008-14.
28. O'Brien KL, Moulton LH, Reid R, Weatherholtz R, Oski J, Brown L, et al. Efficacy and safety of seven-valent conjugate pneumococcal vaccine in American Indian children: group randomised trial. Lancet 2003;362:355-61.
29. Black S, France EK, Center KJ, Hansen J, Lewis E, Graepel J, et al. Postmarketing assessment of uncommon events following Prevnar, 7-valent pneumococcal conjugate vaccine. IDSA 44th annual meeting, October 2006, Toronto, Canada.
30. Black S, France EK, Center KJ, Hansen J, Lewis E, Graepel J, et al. Kawasaki Disease (KD) following immunization: Case series from a large safety surveillance study of Prevnar, 7-valent pneumococcal conjugate vaccine. IDSA 44th annual meeting, October 2006, Toronto, Canada.
31. Dagan R, Melamed R, Zamir O, Leroy O. Safety and immunogenicity of tetravalent pneumococcal vaccines containing 6B, 14, 19F and 23F polysaccharides conjugated to either tetanus toxoid or diphtheria toxoid in young infants and their boosterability by native polysaccharide antigens. Pediatr Infect Dis J 1997;16:1053-9.
32. King JC Jr, Vink PE, Farley JJ, Smilie M, Parks M, Lichenstein R. Safety and immunogenicity of three doses of a five-valent pneumococcal conjugate vaccine in children younger than two years with and without human immunodeficiency virus infection. Pediatrics 1997;99:575-80.
33. Mbelle N, Huebner RE, Wasas AD, Kimura A, Chang I, Klugman KP. Immunogenicity and impact on nasopharyngeal carriage of a nonavalent pneumococcal conjugate vaccine. J Infect Dis 1999;180:1171-6.
34. Klugman KP, Madhi SA, Huebner RE, Kohberger R, Mbelle N, Pierce N; Vaccine Trialists Group. A trial of a 9-valent pneumococcal conjugate vaccine in children with and those without HIV infection. N Engl J Med 2003;349:1341-8.
35. Obaro SK, Enwere GC, Deloria M, Jaffar S, Goldblatt D, Brainsby K, et al. Safety and immunogenicity of pneumococcal conjugate vaccine in combination with diphtheria, tetanus toxoid, pertussis and Haemophilus influenzae type b conjugate vaccine. Pediatr Infect Dis J 2002;21:940-7.
36. Cutts FT, Zaman SM, Enwere G, Jaffar S, Levine OS, Okoko JB, et al. Gambian Pneumococcal Vaccine Trial Group. Efficacy of nine-valent pneumococcal conjugate vaccine against pneumonia and invasive pneumococcal disease in The Gambia: randomised, double-blind, placebo-controlled trial. Lancet 2005;365:1139-46.
37. Buttery JP, Riddell A, McVernon J, Chantler T, Lane L, Bowen-Morris J, et al. Immunogenicity and safety of a combination pneumococcal-meningococcal vaccine in infants: a randomized controlled trial. JAMA 2005;293:1751-8.
38. Dagan R, Kayhty H, Wuorimaa T, Yaich M, Bailleux F, Zamir O, et al. Tolerability and immunogenicity of an eleven valent mixed carrier Streptococcus pneumoniae capsular polysaccharide-diphtheria toxoid or tetanus protein conjugate vaccine in Finnish and Israeli infants. Pediatr Infect Dis J 2004;23:91-8.
39. Wuorimaa T, Käyhty H, Leroy O, Eskola J. Tolerability and immunogenicity of an 11-valent pneumococcal conjugate vaccine in adults. Vaccine 2001;19:1863-9.
40. Wuorimaa T, Dagan R, Eskola J, Janco J, Ahman H, Leroy O, et al. Tolerability and immunogenicity of an eleven-valent pneumococcal conjugate vaccine in healthy toddlers. Pediatr Infect Dis J 2001;20:272-7.
41. Feikin DR, Elie CM, Goetz MB, Lennox JL, Carlone GM, Romero-Steiner S, et al. Randomized trial of the quantitative and functional antibody responses to a 7-valent pneumococcal conjugate vaccine and/or 23-valent polysaccharide vaccine among HIV-infected adults. Vaccine 2001;20:545-53.
42. Kumar D, Rotstein C, Miyata G, Arlen D, Humar A. Randomized, double-blind, controlled trial of pneumococcal vaccination in renal transplant recipients. J Infect Dis 2003;187:1639-45.
43. Lin PL, Michaels MG, Green M, Mazariegos GV, Webber SA, Lawrence KS, et al. Safety and immunogenicity of the American Academy of Pediatrics-Recommended Sequential Pneumococcal Conjugate and Polysaccharide Vaccine Schedule in Pediatric Solid Organ Transplant Recipients. Pediatrics 2005;116:160-7
44. Shinefield H, Black S, Ray P, Fireman B, Schwalbe J, Lewis E. Efficacy, immunogenicity and safety of heptavalent pneumococcal conjugate vaccine in low birth weight and preterm infants. Pediatr Infect Dis J 2002;21:182-6.
45. Esposito S, Pugni L, Bosis S, Proto A, Cesati L, Bianchi C, 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. Vaccine 2005;23:1703-8.
46. Jackson LA, Neuzil KM, Whitney CG, Starkovich P, Dunstan M, Yu O, et al. Safety of varying dosages of 7-valent pneumococcal protein conjugate vaccine in seniors previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. Vaccine 2005;23:3697-703.
47. Lucero MG. Effectiveness of an 11-valent pneumococcal conjugate vaccine for preventing radiographically confirmed pneumonia in children under 2 years of age: A randomized, double-blind, placebo-controlled trial in the Philippines. 12th International Society for Infectious Diseases, Lisbon, Portugal, June 2006.
48. National, state, and urban area vaccination coverage among children aged 19-35 months - United States, 2005. Centers for Disease Control and Prevention (CDC). MMWR Morb Mortal Wkly Rep 2006;55:988-93.
49. Whitney CG, Farley MM, Hadler J, Harrison LH, Bennett NM, Lynfield R, et al. Decline in invasive pneumococcal disease after the introduction of proteinpolysaccharide conjugate vaccine. N Engl J Med 2003;348:1737-46.
50. Singleton RJ, Hennessy TW, Bulkow LR, Hammitt LL, Zulz T, Hurlburt DA, 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;297:1784-92.
51. Pneumococcal conjugate vaccine for childhood immunization - WHO position paper. Wkly Epidemiol Rec 2007;82:93-104.