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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  15 months
Study #:  1
Study Type:  Safety/Immunogenicity
Study Design:  Randomized/ Controlled
No Patients:  3538
No Centers:  16
No Countries:  1