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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  09/12/2008
 
Trade Name:  GARDASIL
 
Generic or Proper Name (*):  Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant*
 
Indications Studied:  Prevention of vulvar and vaginal cancer caused by HPV types 16 and 18
 
Therapeutic Category:  Preventive Vaccine
 
Ages Studied:  9-26 years
 
Study #:  1
 
Study Type:  Efficacy/Safety/Immunogenicity
 
Study Design:  Controlled
 
No Patients:  3251
 
BPCA(B), PREA(P):  P
 
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