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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  06/20/2008
 
Trade Name:  Pentacel
 
Generic or Proper Name (*):  Diphtheria And Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine*
 
Indications Studied:  Active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b
 
Therapeutic Category:  Preventive Vaccine
 
Ages Studied:  2 - 17 months
 
Study #:  5
 
Study Type:  Safety/Immunogenicity
 
Study Design:  Open Label
 
No Patients:  1257
 
No Centers:  38
 
No Countries:  1
 
BPCA(B), PREA(P):  P
 
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