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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  06/24/2008
 
Trade Name:  KINRIX
 
Generic or Proper Name (*):  Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine*
 
Indications Studied:  Active immunization against diphtheria, tetanus, pertussis, & poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series when previous DTaP vaccine doses have been with INFANRIX and/or PEDIARIX and for the first three doses and INFANRIX for the fourth dose
 
Therapeutic Category:  Preventive Vaccine
 
Ages Studied:  4  6 years
 
Study #:  1
 
Study Type:  Safety/Immunogenicity
 
Study Design:  Open Label/Active Control
 
No Patients:  4209
 
No Centers:  24
 
No Countries:  2
 
BPCA(B), PREA(P):  P
 
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