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

Volumn 28, Issue 25, 2010, Pages 4192-4203

  Kieninger, Dorothee M ^a   Kueper, Kathrin ^a   Steul, Katrin ^a   Juergens, Christine ^b   Ahlers, Norbert ^b   Baker, Sherryl ^b   Jansen, Kathrin U ^b   Devlin, Carmel ^b   Gruber, William C ^b   Emini, Emilio A ^b   Scott, Daniel A ^b  

^a UNIVERSITY MEDICAL CENTER MAINZ   (Germany)

^b PFIZER INC   (United States)

Author keywords

13 valent pneumococcal conjugate vaccine; Immunogenicity; Safety

Indexed keywords

DIPHTHERIA PERTUSSIS POLIOMYELITIS TETANUS HAEMOPHILUS INFLUENZAE TYPE B HEPATITIS B VACCINE; PNEUMOCOCCUS VACCINE;

ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DECREASED APPETITE; DIPHTHERIA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FEVER; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; GERMANY; HAEMOPHILUS INFECTION; HEPATITIS B; HUMAN; IMMUNOGENICITY; INFANT; INFECTION PREVENTION; INJECTION SITE REACTION; INJECTION SITE SWELLING; IRRITABILITY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PARALLEL DESIGN; PERTUSSIS; PNEUMOCOCCAL INFECTION; POLIOMYELITIS; PRIORITY JOURNAL; PROTECTION; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SKIN REDNESS; SLEEP; TETANUS; VACCINATION;

ANTIBODIES, BACTERIAL; DOUBLE-BLIND METHOD; FEMALE; GERMANY; HUMANS; IMMUNIZATION SCHEDULE; IMMUNOGLOBULIN G; INFANT; MALE; PNEUMOCOCCAL INFECTIONS; PNEUMOCOCCAL VACCINES; VACCINES, CONJUGATE;

EID: 77952584765     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2010.04.008     Document Type: Article

References (44)

1. Pneumococcal conjugate vaccine for childhood immunization - WHO position paper. Wkly Epidemiol Rec 2007;82:93-104.
2. Black S., Shinefield H., Fireman B., Lewis E., Ray P., Hansen J.R., et al. Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children. Pediatr Infect Dis J 19 (2000) 187-195
3. Eskola J., Kilpi T., Palmu A., Jokinen J., Haapakoski J., Herva E., et al. Efficacy of a pneumococcal conjugate vaccine against acute otitis media. N Engl J Med 344 6 (2001) 403-409 [Summary for patients in Can Fam Physician 2002 Nov;48:1777-9; PMID: 12506948]
4. Centers for Disease Control and Prevention. Invasive pneumococcal disease in children 5 years after conjugate vaccine introduction - eight states, 1998-2005. MMWR Morb Mortal Wkly Rep 2008;57(06):144-8.
5. Hansen J., Black S., Shinefield H., Cherian T., Benson J., Fireman B., 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 25 9 (2006) 779-781
6. Poehling K.A., Talbot T.R., Griffin M.R., Craig A.S., Whitney C.G., Zell E., et al. Invasive pneumococcal disease among infants before and after introduction of pneumococcal conjugate vaccine. JAMA 295 14 (2006) 1668-1674
7. Talbot T.R., Poehling K.A., Hartert T.V., Arbogast P.G., Halasa N.B., Mitchel E., et al. Elimination of racial differences in invasive pneumococcal disease in young children after introduction of the conjugate pneumococcal vaccine. Pediatr Infect Dis J 23 8 (2004) 726-731
8. Whitney C.G., Pilishvili T., Farley M.M., Schaffner W., Craig A.S., Lynfield R., et al. Effectiveness of seven-valent pneumococcal conjugate vaccine against invasive pneumococcal disease: a matched case-control study. Lancet 368 9546 (2006) 1495-1502 [See comment]
9. Zhou F., Kyaw M.H., Shefer A., Winston C.A., and Nuorti J.P. Health care utilization for pneumonia in young children after routine pneumococcal conjugate vaccine use in the United States. Arch Pediatr Adolesc Med 161 12 (2007) 1162-1168
10. Grijalva C.G., Nuorti J.P., Arbogast P.G., Martin S.W., Edwards K.M., and Griffin M.R. Decline in pneumonia admissions after routine childhood immunisation with pneumococcal conjugate vaccine in the USA: a time-series analysis. Lancet 369 9568 (2007) 1179-1186
11. 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 23 14 (2005) 1703-1708
12. Vestrheim D.F., Lovoll O., Aaberge I.S., Caugant D.A., Hoiby E.A., Bakke H., et al. Effectiveness of a 2 + 1 dose schedule pneumococcal conjugate vaccination programme on invasive pneumococcal disease among children in Norway. Vaccine 26 26 (2008) 3277-3281
13. Centers for Disease Control and Prevention. Direct and indirect effects of routine vaccination of children with 7-valent pneumococcal conjugate vaccine on incidence of invasive pneumococcal disease - United States, 1998-2003. MMWR Morb Mortal Wkly Rep 2005;54(36):893-7.
14. Haber M., Barskey A., Baughman W., Barker L., Whitney C.G., Shaw K.M., et al. Herd immunity and pneumococcal conjugate vaccine: a quantitative model. Vaccine 25 29 (2007) 5390-5398
15. Millar E.V., Watt J.P., Bronsdon M.A., Dallas J., Reid R., Santosham M., et al. Indirect effect of 7-valent pneumococcal conjugate vaccine on pneumococcal colonization among unvaccinated household members. Clin Infect Dis 47 8 (2008) 989-996 [See comment]
16. Health Protection Agency. Cumulative weekly number of reports of invasive pneumococcal disease due to any of the seven serotypes in Prevenar™: persons aged >5 years in England and Wales by epidemiological year: July-June (2003-to date). http://www.hpa.org.uk/web/HPAweb&HPAwebStandard/HPAweb_C/1239951968966 [Accessed January 29, 2010].
17. Black S.B., Cimino C.O., Hansen J., Lewis E., Ray P., Corsaro B., 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 (2006) 306-311
18. Knuf M., Habermehl P., Cimino C., Petersen G., and Schmitt H.J. 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 24 (2006) 4727-4736
19. Schmitt H.J., Faber J., Lorenz I., Schmole-Thoma B., and 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 21 25-26 (2003) 3653-3662
20. GSP Summary Report (Stage 1; Version 1) for SAGE meeting November 6-8, 2007; October 18, 2007 version (public document).
21. Centers for Disease Control and Prevention. Emergence of antimicrobial-resistant serotype 19A Streptococcus pneumoniae - Massachusetts, 2001-2006. MMWR Morb Mortal Wkly Rep 2007;56(41):1077-80.
22. Chen M., Sun Z., Zhao R., Zhang L., Wang H., Zhang H., et al. Serotype distribution and antimicrobial resistance patterns of Streptococcus pneumoniae isolated from children in China younger than 5 years. Diagn Microbiol Infect Dis 61 3 (2008) 256-263
23. Munoz-Almagro C., Jordan I., Gene A., Latorre C., Garcia-Garcia J.J., and Pallares R. Emergence of invasive pneumococcal disease caused by nonvaccine serotypes in the era of 7-valent conjugate vaccine. Clin Infect Dis 46 2 (2008) 174-182
24. Shinefield H.R., and Black S. Efficacy of pneumococcal conjugate vaccines in large scale field trials. Pediatr Infect Dis J 19 4 (2000) 394-397
25. Dagan R., Givon-Lavi N., Fraser D., Lipsitch M., Siber G.R., and 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 (2005) 367-376
26. Kyaw M.H., Lynfield R., Schaffner W., Craig A.S., Hadler J., Reingold A., et al. Effect of introduction of the pneumococcal conjugate vaccine on drug-resistant Streptococcus pneumoniae. N Engl J Med 354 14 (2006) 1455-1463
27. Schuchat A., and Bell B.P. Monitoring the impact of vaccines postlicensure: new challenges, new opportunities. Expert Rev Vaccines 7 4 (2008) 437-456
28. Abdelnour A., Soley C., Guevara S., Porat N., Dagan R., and Arguedas A. Streptococcus pneumoniae serotype 3 among Costa Rican children with otitis media: clinical, epidemiological characteristics and antimicrobial resistance patterns. BMC Pediatr 9 (2009) 52
29. Bender J.M., Ampofo K., Korgenski K., Daly J., Pavia A.T., Mason E.O., et al. Pneumococcal necrotizing pneumonia in Utah: does serotype matter?. Clin Infect Dis 46 9 (2008) 1346-1352 [Erratum appears in Clin Infect Dis 2008;47(3):437]
30. Porat N., Soley C., Marengolciene M.M., Greenberg D., Givon-Lavi N., Trefler R., et al. An international serotype 3 clone causing pediatric noninvasive infections in Israel, Costa Rica, and Lithuania. Pediatr Infect Dis J 27 8 (2008) 709-712
31. Quataert S., Martin D., Anderson P., Giebink G.S., Henrichsen J., Leinonen M., et al. A multi-laboratory evaluation of an enzyme-linked immunoassay quantitating human antibodies to Streptococcus pneumoniae polysaccharides. Immunol Invest 30 3 (2001) 191-207
32. Quataert S.A., Kirch C.S., Quackenbush Wiedl L.J., Phipps D.C., Strohmeyer S., Cimino C.O., et al. Assignment of weight-based antibody units to a human antipneumococcal standard reference serum, lot 89-S. Clin Diagn Lab Immunol 2 5 (1995) 590-597
33. Baker S., Hu B.T., Hackell J., Razmpour A., Scott D.A., Tam J.S., et al. Effect of addition of heterologous pneumococcal polysaccharide 22F to the Wyeth/WHO pneumococcal polysaccharide ELISA on IgG assignments for infant sera. 5th international symposium on pneumococci and pneumococcal diseases (ISPPD): biennial meeting (2006) 285 [Abstract]
34. Siber G.R., Chang I., Baker S., Fernsten P., O'Brien K.L., Santosham M., et al. Estimating the protective concentration of anti-pneumococcal capsular polysaccharide antibodies. Vaccine 25 19 (2007) 3816-3826
35. Hu B.T., Yu X., Jones T.R., Kirch C., Harris S., Hildreth S.W., et al. Approach to validating an opsonophagocytic assay for Streptococcus pneumoniae. Clin Diagn Lab Immunol 12 2 (2005) 287-295
36. Romero-Steiner S., Libutti D., Pais L.B., Dykes J., Anderson P., Whitin J.C., et al. Standardization of an opsonophagocytic assay for the measurement of functional antibody activity against Streptococcus pneumoniae using differentiated HL-60 cells. Clin Diagn Lab Immunol 4 4 (1997) 415-422
37. World Health Organization. Recommendations for the production and control of pneumococcal conjugate vaccines. WHO Technical Report Series, No. 927; 2005.
38. Jodar L., Butler J., Carlone G., Dagan R., Goldblatt D., Kayhty H., et al. Serological criteria for evaluation and licensure of new pneumococcal conjugate vaccine formulations for use in infants. Vaccine 21 23 (2003) 3265-3272
39. Chan I.S.F., and Zhang Z. Test-based exact confidence intervals for the difference of two binomial proportions. Biometrics 55 4 (1999) 1202-1209
40. The German childhood vaccination schedule. German Standing Committee on Vaccination (STIKO): 7/2009.
41. Gimenez-Sanchez F., Kieninger D.M., Kueper K., Martinon-Torres F., Bernaola E., Diez-Domingo J., et al. Immunogenicity of DTaP-HBV-IPV/hib combination vaccine antigens when given concomitantly with 13-valent pneumococcal conjugate vaccine in healthy infants and toddlers. 47th Infectious Disease Society of America (IDSA): annual meeting (2009) [Abstract]
42. Huebner R.E., Mbelle N., Forrest B., Madore D.V., and Klugman K.P. 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 21 11 (2002) 1004-1007
43. Kayhty H., Ahman H., Eriksson K., Sorberg M., and Nilsson L. Immunogenicity and tolerability of a heptavalent pneumococcal conjugate vaccine administered at 3, 5 and 12 months of age. Pediatr Infect Dis J 24 2 (2005) 108-114
44. Kaye P., Malkani R., Martin S., Slack M., Trotter C., Jit M., et al. Invasive pneumococcal disease (IPD) in England & Wales after 7-valent conjugate vaccine (PCV7); potential impact of 10 and 13-valent vaccines (2009), Health Protection Agency