Immunogenicity and safety of a pentavalent acellular pertussis combined vaccine including diphtheria, tetanus, inactivated poliovirus and conjugated Haemophilus Influenzae type b polysaccharide for primary vaccination at 2, 3, 4 or 3, 4, 5 months of age in infants in China

Vaccine

Volumn 29, Issue 10, 2011, Pages 1913-1920

  Li, Rong Cheng ^a   Li, Feng Xiang ^b   Li, Yan Ping ^a   Hou, Qi Ming ^b   Li, Chang Gui ^b   Li, Ya Nan ^b   Chen, Fu Sheng ^c   Hu, Xue Zhong ^d   Su, Wen Bin ^e   Zhang, Shu Min ^b   Fang, Han Hua ^b   Ye, Qiang ^b   De Zeng, Tian ^c   Liu, Tao Xuan ^d   Li, Xiu Bi ^e   Huang, Yun Neng ^f   Deng, Man Ling ^f   Zhang, Yan Ping ^g   Ortiz, Esteban ^h  

^a Guanxi Autonomous Region Center for Disease Prevention and Control   (China)

^b NATIONAL INSTITUTE FOR THE CONTROL OF PHARMACEUTICAL AND BIOLOGICAL PRODUCTS   (China)

^c Ping Le County Center for Disease Prevention and Control   (China)

^d Li Pu County Center for Disease Prevention and Control   (China)

^e Yang Shuo County Center for Disease Prevention and Control   (China)

^f Gui Lin City Center for Disease Prevention and Control   (China)

^g Sanofi Pasteur ^*  (China)

^h SANOFI PASTEUR   (France)

Author keywords

China; Immunogenicity; Pentavalent vaccine; Primary series; Safety

Indexed keywords

ACT HIB; DIPHTHERIA PERTUSSIS POLIOMYELITIS TETANUS HAEMOPHILUS INFLUENZAE TYPE B VACCINE; DIPHTHERIA PERTUSSIS TETANUS VACCINE; DIPHTHERIA VACCINE; DIPLOID CELL VACCINE; HAEMOPHILUS INFLUENZAE TYPE B VACCINE; PENTAXIM; PERTUSSIS VACCINE; POLIOMYELITIS VACCINE; TETANUS TOXOID; UNCLASSIFIED DRUG;

ACTIVE IMMUNIZATION; ANOREXIA; ANTIBODY TITER; ARTICLE; CHINA; CRYING; DIPHTHERIA; DROWSINESS; DRUG SAFETY; FEMALE; FEVER; HAEMOPHILUS INFECTION; HUMAN; IMMUNOGENICITY; IMMUNOREACTIVITY; INFANT; INJECTION SITE ERYTHEMA; INJECTION SITE REACTION; INJECTION SITE SWELLING; IRRITABILITY; MALE; NORMAL HUMAN; PERTUSSIS; PHASE 3 CLINICAL TRIAL; POLIOMYELITIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEIZURE; SEROCONVERSION; SIDE EFFECT; TETANUS; VACCINATION; VOMITING;

AGE FACTORS; ANTIBODIES, BACTERIAL; ANTIBODIES, VIRAL; CHINA; DIPHTHERIA-TETANUS-PERTUSSIS VACCINE; FEMALE; HAEMOPHILUS VACCINES; HEPATITIS B VACCINES; HUMANS; IMMUNIZATION, SECONDARY; INFANT; MALE; POLIOVIRUS VACCINE, INACTIVATED; VACCINATION; VACCINES, CONJUGATE;

EID: 79951724991     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2010.12.103     Document Type: Article

References (47)

1. Bland J., Clements J. Protecting the world's children: the story of WHO's immunization programme. World Health Forum 1998, 19(2):162-173.
2. Decker M.D. Principles of pediatric combination vaccines and practical issues related to use in clinical practice. Pediatr Infect Dis J 2001, 20(11 Suppl):S10-S18.
3. Kalies H., Grote V., Verstraeten T., Hessel L., Schmidt H.J., von Kries R. The use of combination vaccines has improved timeliness of vaccination in children. Pediatr Infect Dis J 2006, 25:507-512.
4. Dodd D. Benefits of combination vaccines: effective vaccination on a simplified schedule. Am J Managed Care 2003, 9(1 Suppl):S6-S12.
5. Edwards K.M., Decker M. Pertussis vaccines. Vaccines 2008, vol. 21:467-517. Saunders Co, Philadephia PA. 5th Edition.
6. Cherry J.D., Brunell PhA, Golden G.S., Karzon D.T. Report of the task force on pertussis and pertussis immunization. Pediatrics 1988, 81:933-984.
7. WHO Vaccine Preventable Diseases Monitoring System 2009 Global Summary.: Accessed 5 November 2010. http://www.who.int/vaccines/globalsummary/immunization/countryprofileselect.cfm.
8. W.H.O. Pertussis vaccines. WHO position paper. Wkly Epidemiol Rec 2005, 80:31-39.
9. Yang Y., Leng Z., Lu D. Pediatric Haemophilus influenzae type b meninngitis in Hefei city: an epidemiologic study (Beijing Children's Hospital). Zhonghua Yi Xue Za Zhi 1998, 78(4):251-253. [Article in Chinese].
10. Yang Y., Leng Z., Shen X., Lu D., Jiang Z., Rao J., et al. Acute bacterial meningitis in children in Hefei China 1990-1992. Chin Med J (Engl) 1996, 109(5):385-388.
11. Levine O.S., Liu G., Garman R.L., Dowell S.F., Yu S., Yang Y.H. Haemophilus influenzae type b and Streptococcus pneumoniae as causes of pneumonia among children in Beijing, China. Respiratory Diseases Branch, National Institute of Allergy and Infectious Diseases, Bethesda, MD 20892-7630, USA. Emerg Infect Dis 2000, 6(2):165-170.
12. Wang Y.J., Vuori-Holopainen E., Yang Y., Wang Y., Hu Y., Leboulleux D., et al. Relative frequency of Haemophilus influenzae type b pneumonia in Chinese children as evidenced by serology. Pediatr Infect Dis J 2002, 21(4):271-277.
13. Peltola H. Worldwide Haemophilus influenzae type b disease at the beginning of the 21st century: global analysis of the disease burden 25 years after the use of the polysaccharide vaccine and a decade after the advent of conjugates. Clin Microbiol Rev 2000, 13:302-317.
14. Kalies H., Verstraeten T., Grote V., Meyer N., Siedler A., Schmitt H.J., et al. Four and one-half-year follow-up of the effectiveness of diphtheria-tetanus toxoids-acellular pertussis/Haemophilus influenzae type b and diphtheria-tetanus toxoids-acellular pertussis-inactivated poliovirus/H. influenzae type b combination vaccines in Germany. Pediatr Infect Dis J 2004, 23(10):944-950.
15. Farhoudi D., Löfdahl M., Giesecke J. Invasive Haemophilus influenzae type b disease in Sweden 1997-2003: epidemiological trends and patterns in the post-vaccine era. Scand J Infect Dis. 2005, 37(10):717-722.
16. Centers for Disease Control and Prevention (CDC) Certification of poliomyelitis eradication-Western Pacific Region, October 2000. MMWR 2001, 50(1):1-3.
17. Centers for Disease Control and Prevention (CDC) Update on vaccine-derived polioviruses-worldwide, January 2006-August 2007. MMWR 2007, 56(38):996-1001.
18. Kew O.M., Sutter R.W., de Gourville E.M., Dowdle W.R., Pallansch M.A. Vaccine-derived polioviruses and the endgame strategy for global polio eradication. Ann Rev Microbiol 2005, 59:587-635.
19. W.H.O. Vaccine-derived polioviruses - update. Wkly Epidemiol Rec (WER) 2006, 81:397-408.
20. Heymann D.L., Sutter R.W., Aylward R.B. A global call for new polio vaccines. The end is near but eradication will not be as simple as once thought. Nature 2005, 434:699-700.
21. Lei J., Li L., Xu A. Analysis of clinical poliomyelitis in Shandong Province from 1993 to 1996. Zhonghua Liu Xing Bing Xue Za Zhi 1998, 19(6):327-329. [Article in Chinese].
22. WHO Global update on vaccine-derived polioviruses, January 2006-August 2007. Wkly Epidemiol Rec 2007, 82(39):337-343.
23. Liang X., Zhang Y., Xu W., Wen N., Zuo S., Lee L.A., et al. An outbreak of poliomyelitis caused by type 1 vaccine-derived poliovirus in China. J Infect Dis 2006, 194(5):545-551.
24. WHO Global Polio Eradication Initiative-Strategic Plan 2009-2013 Framework for the new GPEI Strategic Plan 2009-2013 (December 2008). Available at: (accessed 2 February 2010). http://www.polioeradication.org/content/publications/PolioStrategicPlan09-13_Framework.pdf.
25. Bonnet M.C., Dutta A. World wide experience with inactivated poliovirus vaccine. Vaccine 2008, 26(39):4978-4983.
26. Sun M., Ma R., Zeng Y., Luo F., Zhang J., Hou W. Immunization status and risk factors of migrant children in densely populated areas of Beijing China. Vaccine 2010, 28(5):1264-1274.
27. Plotkin S.A. Correlates of protection induced by vaccination. Clin Vaccine Immunol 2010, 17(7):1055-1065.
28. Mallet E., Hoffenbach A., Salomon H., Blondeau C., Fritzell B. Primary immunization with combined, acellular DTaP-IPV-Act-HIB vaccine given at 2-3-4 or 2-4-6 months of age. The 14th European Societies for Paediatric Infectious Diseases 1996, (Abstract 19).
29. WHO. United Nations prequalified vaccines (WHO list of vaccines for purchase by UN agencies as of September 2009). Available from URL: (accessed 5 November 2010). http://www.who.int/immunization_standards/vaccine_quality/PQ_vaccine_list_en/en/index.html.
30. Capeding R.M., Cadorna-Carlos J., Book-Montellano M., Ortiz E. Immunogenicity and safety of a DTaP-IPV//PRP-T combination vaccine at 6, 10, 14 weeks of age (EPI schedule) and concomitant Hepatitis B vaccination at birth, 6, 14 or 6, 10, 14 weeks of age. WHO Bull 2008, 86:443-451.
31. Carlsson R.M., Claesson B.A., Selstam U., Fagerlund E., Granstrom M., Blondeau C., 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.
32. Dutta K, Verghese VP, Pemde HK, Mathew LG, Ortiz E. Immunogenicity and safety of a pentavalent diphtheria, tetanus, acellular pertussis, inactivated poliovirus, Haemophilus influenzae type b conjugate combination vaccine (Pentaxim®) at 6, 10, 14 weeks of age. Indian Pediatrics. 2009;46:975-982.
33. Kanra G., Selier T., Yurdakök K., Yavuz T., Baskan S., Ulukol B., et al. Immunogencity study of a combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis vaccine used to reconstitute a freeze-dried Haemophilus influenzae type b vaccine (DTaP-IPV//PRP-T) administered simultaneously with a hepatitis B vaccine at two, three and four months of life. Vaccine 2000, 18:947-954.
34. Lagos R., Kotloff K.L., Hoffenbach A., San Martin O., Abrego P., Ureta A.M., et al. Clinical acceptability and immunogenicity of a pentavalent parenteral combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b conjugate antigens in two-, four- and six month-old Chilean infants. Pediatr Infect Dis J 1998, 17:294-304.
35. Mallet E., Fabre P., Pines E., Salomon H., Staub T., Schödel F., et al. Immunogenicity and safety of a new liquid hexavalent combined vaccine compared with separate administration of reference licensed vaccines in infants. Pediatr Infect Dis J 2000, 19:1119-1127.
36. Thisyakorn U., Pancharoen C., Chuenkitmongkol S., Ortiz E. Immunogenicity and safety of a DTaP-IPV//PRP-T vaccine (Pentaxim) booster during the second year of life in Thai children primed with an acellular pertussis combined vaccine. SouthEast Asian J Trop Med Public Health 2009, 40(2):282-294.
37. Vidor E., Plotkin S.A. Immunogenicity of a two-component (PT & FHA) acellular pertussis vaccine in various combinations. Hum Vaccine 2008, 4:328-340.
38. Li C.G., Ying Z.F., Wang J.F., Fang H.H., Li Y.P., Li R.C., et al. Effectiveness of inactivated poliomyelitis vaccine for primary vaccination. Zhonghua Yu Fang Yi Xue Za Zhi. 2009, 43(6):501-503.
39. Gustafsson L., Hessel L., Storsaeter J., Olin P. Long-term follow-up of Swedish children vaccinated with acellular pertussis vaccines at 3, 5, and 12 months of age indicates the need for a booster dose at 5-7 years of age. Pediatrics 2006, 118(3):978-984.
40. Swedish Institute for Infectious Disease Control. Pertussis surveillance in Sweden with enhanced follow-up of cohorts immunized with acellular pertussis vaccines 2006 Appendix 2 SP-MSD.Available from URL: (accessed 5 November 2010). http://www.smittskyddsinstitutet.se/upload/PDF-filer/seven-year-report-app-2-SP-MSD.pdf.
41. Hessel L, Mast CH,. Teyssou R. Effectiveness of the 2-component acellular pertussis combination vaccine 5 years experience of routine practice in Sweden. Int J Infect Dis. 2004; 8 (Suppl 1):S75 abstract 18.023. Int J Infect Dis. 2004; 8 (Suppl 1):S75 Abstract 18.023.Available at URL: (accessed 5 November 2010). http://www.isid.org/Downloads/11th_ICID_Abstracts.pdf.
42. Olin P., Hallander H.O. Marked decline in pertussis followed reintroduction of pertussis vaccination in Sweden. EuroSurveill 1999, 4:128-129.
43. Swedish Institute for Infectious Disease Control. Pertussis surveillance in Sweden with enhanced follow-up of cohorts immunized with acellular pertussis vaccines 2007. Available at URL: (accessed 5 November 2010). http://www.smittskyddsinstitutet.se/upload/SMI-rapport%2520nr%25204-2008.pdf.
44. Carlsson RM, Gustafsson L Ten Year Report: Pertussis surveillance in Sweden Progress Report October 1, 1997-December 31, 2007 with an executive summary. Available at URL: Cited on 28 January (2010). http://www.smittskyddsinstitutet.se/upload/SMI-rapport%2520nr%25204-2008.pdf.
45. Decker M.D., Edwards K.M., Steinhoff M.C., Rennels M.B., Pichichero M.E., Englund J.A., et al. Comparison of 13 acellular pertussis vaccines: adverse reactions. Pediatrics 1995, 96:557-566.
46. Eglund J.A., Decker M.D., Edwards K.M., Pichichero M.E., Steinhoff M.C., Anderson E.L. Acellular and whole-cell pertussis vaccines as booster doses: a multicenter study. Pediatrics 1994, 93:37-43.
47. Pichichero M.E., Deloria M.A., Rennels M.B., Anderson E.L., Edwards K.M., decker M.D., et al. A safety and immunogenicity comparison of 12 acellular pertussis vaccines and one whole-cell pertussis vaccine given as a fourth dose in 15- to 20-month-old children. Pediatrics 1997, 100:772-788.