Safety and immunogenicity of a DTaP-IPVVero (serum-free) combination vaccine in comparison to DTaP-IPVMkc when administered simultaneously with Haemophilus influenzae type b conjugate vaccine (PRP-T) in children at 2, 3.5, 5 and 16 months of age

Vaccine

Volumn 26, Issue 41, 2008, Pages 5296-5303

  Pietrzyk, Jacek J ^a   Wysocki, Jacek ^b   Pejcz, Jerzy ^c   Galaj, Andrzej ^d   Majda Stanislawska, Ewa ^e   Käyhty, Helena ^f   Thierry Carstensen, Birgit ^g   Jensen, Anders Mørup ^g  

^a JAGIELLONIAN UNIVERSITY   (Poland)

^b POZNAN UNIVERSITY OF MEDICAL SCIENCES   (Poland)

^c Department of Paediatrics   (Poland)

^d VITAMED   (Poland)

^e MEDICAL UNIVERSITY OF LODZ   (Poland)

^f NATIONAL PUBLIC HEALTH INSTITUTE   (Finland)

^g STATENS SERUM INSTITUT   (Denmark)

Author keywords

Clinical trial; DTaP IPV; Immunogenicity

Indexed keywords

DIPHTHERIA PERTUSSIS TETANUS HAEMOPHILUS INFLUENZAE TYPE B VACCINE; DTAP IPV MKC; DTAP IPV MKC VACCINE; DTAP IPV VERO; DTAP IPV VERO VACCINE; HAEMOPHILUS INFLUENZAE TYPE B CONJUGATE VACCINE; HAEMOPHILUS INFLUENZAE TYPE B VACCINE; UNCLASSIFIED DRUG;

ANTIBODY RESPONSE; ANTIBODY TITER; ARTICLE; BOOSTER VACCINATION; BRONCHITIS; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CRYING; DECREASED APPETITE; DOSE TIME EFFECT RELATION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEVER; HAEMOPHILUS INFLUENZAE TYPE B; HUMAN; IMMUNOGENICITY; INFANT; INJECTION SITE EDEMA; INJECTION SITE ERYTHEMA; INJECTION SITE GRANULOMA; INJECTION SITE SWELLING; INSOMNIA; IRRITABILITY; LEG EDEMA; MAJOR CLINICAL STUDY; MULTICENTER STUDY; NEWBORN; PHARYNGITIS; PHASE 3 CLINICAL TRIAL; POLIOMYELITIS; POLIOMYELITIS VIRUS 1; POLIOMYELITIS VIRUS 2; POLIOMYELITIS VIRUS 3; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SIDE EFFECT; SOMNOLENCE; TREATMENT INDICATION; TREATMENT RESPONSE; VACCINATION;

CHILD; DIPHTHERIA-TETANUS-PERTUSSIS VACCINE; FEMALE; HAEMOPHILUS VACCINES; HUMANS; IMMUNIZATION SCHEDULE; IMMUNIZATION, SECONDARY; INFANT; MALE; POLIOVIRUS VACCINE, INACTIVATED; TETANUS TOXOID; VACCINES, COMBINED; VACCINES, CONJUGATE;

EID: 58149261785     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2008.07.033     Document Type: Article

References (32)

1. Marshall G.S., Happe L.E., Lunacsek O.E., Szymanski M.D., Woods C.R., Zahn M., et al. Use of combination vaccines is associated with improved coverage rates. Pediatr Infect Dis 26 (2007) 496-500
2. Capiau C., Poolman J., Hoet B., Bogaerts H., and Andre F. Development and clinical testing of multivalent vaccines based on diphtheria-tetanus-acellular pertussis vaccine: difficulties encountered and lessons learned. Vaccine 21 (2003) 2273-2287
3. Mallet E., Belohradsky B.H., Lagos R., Gothefors L., Camier P., and Carriére J.P. A liquid hexavalent combined vaccine against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type B and hepatitis B: review of immunogenicity and safety. Vaccine 22 (2004) 1343-1357
4. Lin T.Y., Wang Y.H., Chang L.Y., Huang H.T.K., Lin P.Y., and Lu H.K. A fully liquid diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis-Haemophilus influenzae type b conjugate vaccine: immunogenicity and safety of primary vaccination in Taiwanese infants. Int J Infect Dis 11 (2007) 129-136
5. Melnick J.L., Wenner H.A., and Philips C.A. Enteroviruses. In: Lenette E.H., and Schmidt N.J. (Eds). Diagnostic procedures for viral, rickettsial and chlamydial infections (1979), American Public Health Association Inc., Washington, DC
6. Miyamura K., Nishio S., Ito A., Murata R., and Kono R. Micro cell culture method for determination of diphtheria toxin and antitoxin titres using Vero cells. J Biol Standard 2 (1974) 189-201
7. Hendriksen C.F.M., Gun J.W., Nagel J., and Kreeftenberg J.G. The toxin binding inhibition test as a reliable in vitro alternative to the toxing neutralization test in mice for the estimation of tetanus antitoxin in human sera. J Biol Standard 16 (1988) 287-297
8. Lagergård T. Clinical trials of a monocomponent pertussis toxoid vaccine (NICHD Ptxd)-a Technical Report. Appendix D: Manual for serological methods. Medical Faculty Gõteborg University; 1995. ISBN 91-88856-00-3.
9. Granström M., and Granström G. Serological correlates in whooping cough. Vaccine 11 4 (1993)
10. Wenger J.D., and Ward J.I. Haemophilus influenzae vaccine. In: Plotkin S.A., and Orenstein W.A. (Eds). Vaccine. 4th ed (2004), W.B Saunders Company, Philadelphia, PA 229-268
11. Newcombe R. Interval estimation for the difference between independent proportions: comparison of eleven methods. Stat Med 17 (1998) 873-890
12. ® 9.1 user's guide (2004), SAS Institute Inc., Cary, NC
13. Gyhrs A., Lyngholm E., Larsen S.O., Aggerbeck H., and Heron I. Immunogenicity and safety of a tetravalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus vaccine. Scand J Infect Dis 31 6 (1999) 579-585
14. Knutsson N., Trollfors B., Taranger J., Bergfors E., Sundh V., Lagergård T., 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 19 31 (2001) 4396-4403
15. Tichmann I., Preidel H., Grunert D., Habash S., Schult R., Maier R., et al. Comparison of the immunogenicity and reactogenicity of two commercially available hexavalent vaccines administered as a primary vaccination course at 2, 4 and 6 months of age. Vaccine 23 (2005) 3272-3279
16. Zepp F., Knuf M., Heininger U., Jahn K., Collard A., Habermehl P., et al. Safety and immunogenicity of a combined hexavalent tetanus, diphtheria, acellular pertussis, hepatitis B, inactivated poliovirus vaccine and Heamophilus influenzae type b conjugate vaccine, for primary immunization of infants. Vaccine 22 (2004) 2226-2233
17. Gabutti G., Zepp F., Shuerman L., Dentico P., Bamfi F., Soncini R., et al. Evaluation of the immunogenicity and reactogenicity of a DTPa-HBV-IPV combination vaccine co-administered with Hib conjugate vaccine either as a single injection of a hexavalent combination or as two separate injections at 3, 5 and 11 months of age. Scand J Infect Dis 36 (2004) 585-592
18. Trollfors B., Taranger J., Lagergård T., Lind L., Sundh V., Zakrisson G., et al. A placebo-controlled trial of a pertussis-toxoid vaccine. N Eng J Med 333 16 (1995) 1045-1050
19. Liese J.G., Stojanov S., Berut F., Minini P., Harzer E., Jow S., et al. Large scale safety study of a liquid hexavalent vaccine (D-T-aP-IPV-PRP-T-HBs) administered at 2, 4, 6 and 12-14 months of age. Vaccine 20 (2002) 448-454
20. Black S., and Greenberg D.A. combined diphtheria, tetanus, five-component acellular pertussis, poliovirus and Haemophilus influenzae type B vaccine. Expert Rev. Vaccines 4 6 (2005) 793-805
21. Schmitt H.J., Schuind A., Knuf M., Beutel K., Schlte-Wissermann H., Gahr M., et al. Clinical experience of a tricomponent acellular pertussis vaccine combined with diphtheria and tetanus toxoids for primary vaccination in 22,505 infants. J Pediatr 129 (1996) 695-701
22. Schmitt H.J., Beutel K., Schuind A., Knuf M., Wagner S., Müschenborn S., et al. Reactogenicity and immunogenicity of a booster dose of a combined diphtheria, tetanus and tricomponent acellular pertussis vaccine at 14-28 months of age. J Pediatr 130 (1997) 616-623
23. Knuf M., Habermehl P., Faber J., Bock H.L., Sänger R., Bogaerts H., et al. Assessment of nine candidate DTP-vaccines with reduced amount of antigen and/or without adjuvant as a fourth (booster-) dose in the second year of life. Vaccine 24 (2006) 5627-5636
24. Käyhty H., Eskola J., Peltola H., Stout M., Samuelson J.S., and Gordon L.K. 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 155 (1987) 100-106
25. Phipps D., West J., Eby R., Koster M., Madore D., and Quataert S. An ELISA employing a Haemophilus influenzae type b oligosaccharide - human serum albumin conjugate correlates with radioantigen binding assay. J Immunol Methods 135 (1990) 121-128
26. Netterlid E., Bruze M., Hindsén M., Isaksson M., and Olin P. Persistent itching nodules after the fourth dose of diphtheria toxoid vaccines without evidence of delayed hypersensitivity to aluminium. Vaccine 22 (2004) 3698-3706
27. Rennels M.B., Deloria M.A., Pichichero M.E., Losonsky G.A., Englund J.A., Meade B.D., et al. Extensive swelling after booster doses of acellular pertussis-tetanus-diphtheria vaccines. Pediatrics 105 (2000) e12
28. Rennels M.B. Extensive swelling reactions occurring after booster doses of diphtheria-tetanus-acelular pertussis vaccines. Semin Pediatr Infect Dis 14 3 (2003) 196-198
29. Marshall H.S., Gold M.S., Gent R., Quinn P.J., Piotto L., Clarke M.F., et al. Ultrasound examination of extensive limb swelling reactions after diphtheria-tetatnus-acellular petussis or reduced-antigen content diphtheria-tetanus-acellular pertussis immunization in pre-school children. Pediatrics 118 (2006) 1501-1509
30. Østergaard E, Sørensen C, Nielsen L, Stawski G. Elimination of interfering activity in serum samples in the Chinese Hamster Ovary pertussis serology assay. Clin Vaccine Immunol; Aug 2008, 1244-1247.
31. Käyhty H., Peltola H., Karanko V., and Mäkelä P.H. The protective level of serum antibodies to the capsular polysaccharide of Haemophilus influenzae type b. J Infect Dis 147 June (6) (1983) 1100
32. Anderson P. The protective level of serum antibodies to the capsular polysaccharide of Haemophilus influenzae type b. J Infect Dis 149 June (6) (1984) 1034-1035