Safety and reactogenicity of a novel DTPa-HBV-IPV combined vaccine given along with commercial Hib vaccines in comparison with separate concomitant administration of DTPa, Hib, and OPV vaccines in infants

Pediatrics
F ZeppPaul Willems

Abstract

Combination vaccines simplify vaccine administration and have the potential to promote compliance and cost-effectiveness by decreasing the number of injections needed to immunize a child. The objective of this study was to assess the safety and reactogenicity of the diphtheria-tetanus toxoid-acellular pertussis-hepatitis B virus-inactivated polio virus (DTPa-HBV-IPV) vaccine when coadministered with different Haemophilus influenzae type B (Hib) vaccines in comparison with separate, commercially available, control vaccines in a 3-dose primary vaccination series. An open-label, randomized, parallel-group study in 5318 infants who were 8 to 16 weeks of age at enrollment was conducted in 90 centers in Germany. The incidence of adverse events that occurred in infants who received the DTPa-HBV-IPV candidate vaccine coadministered with 1 of 4 different Hib vaccines (given in separate sites; groups 1-4) was compared with the incidence that occurred in infants who received commercially available control vaccines (DTPa, Hib, and oral polio virus [OPV] vaccine; group 5) administered separately. The vaccines were given as a 3-dose primary series at 3, 4, and 5 months of age. Infants were assessed for solicited local and general adverse eve...Continue Reading

References

May 26, 1998·Australian and New Zealand Journal of Public Health·C BowerB Wild

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Citations

May 23, 2003·Current Infectious Disease Reports·Flor M. Munoz, Wendy A. Keitel
Mar 23, 2004·Journal of the American Academy of Dermatology·Jashin J WuStephen K Tyring
Aug 11, 2007·Journal of Paediatrics and Child Health·Terry NolanCatherine Streeton
Dec 5, 2002·Pharmacoepidemiology and Drug Safety
May 14, 2005·Expert Review of Vaccines·Sylvia H Yeh
Mar 9, 2006·Seminars in Pediatric Infectious Diseases·Flor M Munoz
Feb 3, 2004·Immunology and Allergy Clinics of North America·Aric L Gregson, Robert Edelman
Apr 26, 2008·Journal of Korean Medical Science·Sangjin ShinMoran Ki
Jul 17, 2003·Clinical Pediatrics·Michael E Pichichero, Lori Stonehocker Quick
Mar 28, 2003·Clinical Pediatrics·David P Greenberg, Sandor Feldman

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