Immunogenicity and tolerability of a heptavalent pneumococcal conjugate vaccine administered at 3, 5 and 12 months of age

Pediatric Infectious Disease Journal

Volumn 24, Issue 2, 2005, Pages 108-114

  Käyhty, Helena ^a   Åhman, Heidi ^b   Eriksson, Karin ^c,f   Sörberg, Mikael ^c,d   Nilsson, Lennart ^e  

^a NATIONAL PUBLIC HEALTH INSTITUTE   (Finland)

^b Wyeth Finland   (Finland)

^c Wyeth Lederle Nordiska AB   (Sweden)

^d KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^e LINKÖPING UNIVERSITY   (Sweden)

^f Swedish Medical Association   (Sweden)

Author keywords

Immune response; Infants; Pneumococcal conjugate vaccine; Pneumococcus

Indexed keywords

BACTERIAL POLYSACCHARIDE; BACTERIUM ANTIBODY; DIPHTHERIA PERTUSSIS TETANUS VACCINE; HAEMOPHILUS INFLUENZAE TYPE B VACCINE; IMMUNOGLOBULIN G; PNEUMOCOCCUS VACCINE; POLIOMYELITIS VACCINE;

ANTIBODY RESPONSE; ANTIBODY TITER; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG TOLERABILITY; ENZYME IMMUNOASSAY; ERYTHEMA; FEVER; GASTROENTERITIS; HAEMOPHILUS INFLUENZAE TYPE B; HEALTH PROGRAM; HUMAN; HUMAN EXPERIMENT; IMMUNE RESPONSE; IMMUNOGENICITY; INFANT; INJECTION SITE; IRRITABILITY; LETHARGY; MULTICENTER STUDY; NORMAL HUMAN; OPEN STUDY; PAIN; PRIORITY JOURNAL; SCARLET FEVER; SEROTYPE; SIDE EFFECT; SKIN MANIFESTATION; VACCINATION;

ANTIBODIES, BACTERIAL; HAEMOPHILUS VACCINES; HUMANS; IMMUNIZATION SCHEDULE; INFANT; MENINGOCOCCAL VACCINES; PNEUMOCOCCAL VACCINES; STREPTOCOCCUS PNEUMONIAE;

EID: 13844254497     PISSN: 08913668     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.inf.0000151022.92222.be     Document Type: Article

References (38)

1. Lee LH, Lee C-J, Frasch CE. Development and evaluation of pneumococcal conjugate vaccine: clinical trials and control tests. Crit Rev Microbiol. 2002;28:27-41.
2. 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;348:1737-1746.
3. 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;19:187-195.
4. Hedlund J, Sörberg M, Henriques Normark B, Kronvall G. Capsular types and antibiotic susceptibility of invasive Streptococcus pneumoniae among children in Sweden. Scand J Infect Dis. 2003;35:452-458.
5. Eskola J, Takala AK, Kela E, Pekkanen E, Kalliokoski R, Leinonen M. Epidemiology of invasive pneumococcal infections in children in Finland. JAMA. 1992;268:3323-3327.
6. Pelton SI, Dagan R, Gaines BM, et al. Pneumococcal conjugate vaccines: proceedings from an interactive symposium at the 41st Interscience Conference on Antimicrobial Agents and Chemotherapy. Vaccine. 2003;21:1562-1571.
7. Schmitt HJ. Pneumococcal conjugate vaccines in Europe, Berlin, Germany, 23-25 August 2000: report of a European advisory board meeting. Vaccine. 2001;19:3347-3354.
8. Black SB, Shinefield HR, Hansen J, Elvin L, Laufer D, Malinoski F. Postlicensure evaluation of the effectiveness of seven-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2001;20:1105-1107.
9. Dagan R, Melamed R, Muallem M, Piglansky L, Yagupsky P. Nasopharyngeal colonization in southern Israel with antibiotic-resistant pneumococci during the first 2 years of life: relation to serotypes likely to be included in pneumococcal conjugate vaccines. J Infect Dis. 1996;174:1352-1355.
10. Eskola J, Kilpi T, Palmu A, et al. Efficacy of a pneumococcal conjugate vaccine against acute otitis media. N Engl J Med. 2001;344:403-409.
11. Kilpi T, Åhman H, Jokinen J, et al. Protective efficacy of a second pneumococcal conjugate vaccine against pneumococcal acute otitis media in infants and children: randomized, controlled trial of a 7-valent pneumococcal polysaccharide-meningococcal outer membrane protein complex conjugate vaccine in 1666 children. Clin Infect Dis. 2003;37:1155-1164.
12. Fireman B, Black SB, Shinefield HR, Lee J, Lewis E, Ray P. Impact of the pneumococcal conjugate vaccine on otitis media. Pediatr Infect Dis J. 2003;22:10-16.
13. Palmu A, Verho J, Jokinen J, Karma P, Kilpi T. The seven-valent pneumococcal conjugate vaccine reduces tympanostomy tube placement in children. Pediatr Infect Dis J. 2004;23:732-738.
14. 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;21:810-815.
15. 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. 2003;349:1341-1348.
16. Käyhty H, Åhman H, Rönnberg PR, Tillikainen R, Eskola J. Pneumococcal polysaccharide-meningococcal outer membrane protein complex conjugate vaccine is immunogenic in infants and children. J Infect Dis. 1995;172:1273-1278.
17. Puumalainen T, Zeta-Capeding MR, Käyhty H, et al. Antibody response to an eleven-valent diphtheria- and tetanus-conjugated pneumococcal conjugate vaccine in Filipino infants. Pediatr Infect Dis J. 2002;21:309-314.
18. Quataert SA, Kirch CS, Wiedl LJ, et al. Assignment of weight-based antibody units to a human antipneumococcal standard reference serum, lot 89-S. Clin Diagn Lab Immunol. 1995;2:590-597.
19. Kayhty H, Eskola J, Peltola H, Stout MG, Samuelson JS, Gordon LK. Immunogenicity in infants of a vaccine composed of Haemophilus influenzae type b capsular polysaccharide mixed with DPT or conjugated to diphtheria toxoid. J Infect Dis. 1987;155:100-106.
20. Nurkka A, Åhman H, Korkeila M, Jäntti V, Käyhty H, Eskola J. Serum and salivary anti-capsular antibodies in infants and children immunized with the heptavalent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2001;20:25-33.
21. Jodar L, Butler J, Carlone G, et al. Serological criteria for evaluation and licensure of new pneumococcal conjugate vaccine formulations for use in infants. Vaccine. 2003;21:3265-3272.
22. 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. Lancet. 2003;362:355-361.
23. World Health Organization, Expert Committee on Biological Standardization. Pneumococcal conjugate vaccines: recommendations for production and quality control of pneumococcal conjugate vaccines. 2003. Available at: http://www.who.int/biologicals/Guidelines/Vaccines.htm.
24. Huebner RE, Mbelle N, Forrest B, Madore DV, Klugman KP. Immunogenicity after one, two or three doses and impact on the antibody response to coadministered antigens of a nonavalent pneumococcal conjugate vaccine in infants of Soweto, South Africa. Pediatr Infect Dis J. 2002;21:1004-1007.
25. Nurkka A, Åhman H, Yaich M, Eskola J, Käyhty H. Serum and salivary anti-capsular antibodies in infants and children vaccinated with octavalent pneumococcal conjugate vaccines, PncD and PncT. Vaccine. 2001;20:194-201.
26. Eskola J, Käyhty H, Takala AK, et al. A randomized, prospective field trial of a conjugate vaccine in the protection of infants and young children against invasive Haemophilus influenzas type b disease. N Engl J Med. 1990;323:1381-1387.
27. Eskola J, Ward J, Dagan R, Goldblatt D, Zepp F, Siegrist CA. Combined vaccination of Haemophilus influenzae type b conjugate and diphtheria-tetanus- pertussis containing acellular pertussis. Lancet. 1999;354:2063-2068.
28. Carlsson RM, Claesson BA, Selstam U, et al. Safety and immunogenicity of a combined diphtheria-tetanus-acellular pertussis-inactivated polio vaccine-Haemophilus influenzae type b vaccine administered at 2-4-6-13 or 3-5-12 months of age. Pediatr Infect Dis J. 1998;17:1026-1033.
29. Knutsson N, Trollfors B, Taranger J, et al. Immunogenicity and reactogenicity of diphtheria, tetanus and pertussis toxoids combined with inactivated polio vaccine, when administered concomitantly with or as a diluent for a Hib conjugate vaccine. Vaccine. 2001;19:4396-4403.
30. Garpenholt O, Hugosson S, Fredlund H, Giesecke J, Olcen P. Invasive disease due to Haemophilus influenzae type b during the first six years of general vaccination of Swedish children. Acta Paediatr. 2000;89:471-474.
31. 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. Vaccine. 2003;21:3653-3662.
32. Gustafsson L, Hallander HO, Olin P, Reizenstein E, Storsaeter J. A controlled trial of a two-component acellular, a five-component acellular, and a whole-cell pertussis vaccine. N Engl J Med. 1996;334:349-355.
33. Borrow R, Goldblatt D, Finn A, et al. Immunogenicity of, and immunologic memory to, a reduced primary schedule of meningococcal C-tetanus toxoid conjugate vaccine in infants in the United Kingdom. Infect Immun. 2003;71:5549-5555.
34. Kurikka S, Käyhty H, Saarinen L, Rönnberg PR, Eskola J, Mäkelä PH. Immunologic priming by one dose of Haemophilus influenzae type b conjugate vaccine in infancy. J Infect Dis. 1995;172:1268-1272.
35. Lucero M, Puumalainen T, Upgo JM, Williams G, Käyhty H, Nohynek H. Similar antibody concentrations at 9 months of age following one or three doses of an adjuvanted 11-valent pneumococcal diphtheria/tetanus conjugated vaccine: a randomized controlled trial in Filipino infants. J Infect Dis. 2004;189:2077-2084.
36. Goldblatt D, Ashton L, Southern J, et al. Immunogenicity and boosting following a reduced number of doses of a pneumococcal conjugate vaccine in infants and toddlers. In: 4th International Symposium on Pneumococci and Pneumococcal Diseases, May 9-13, 2004, Helsinki, Finland. Helsinki, Finland: National Health Institute; 2004:206:
37. 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. 2000;30:100-121.
38. Pilishvili T, Farley M, Vazquez M, et al. Effectiveness of heptavalent pneumococcal conjugate vaccine in children. In: 43rd Interscience Conference on Antimicrobial Agents and Chemotherapy, September 14-17, 2003, Chicago, IL. Washington, DC: American Society for Microbiology; 2003. Abstract G-1079.