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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  10/16/2009
 
Trade Name:  GARDASIL
 
Generic or Proper Name (*):  Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant*
 
Indications Studied:  Prevention of genital warts caused by HPV 6 and 11
 
Therapeutic Category:  Preventive Vaccine
 
Ages Studied:  9-26 years
 
Study #:  1
 
Study Type:  Safety/Immunogenicity
 
Study Design:  Double-blind/Controlled
 
No Patients:  1364
 
BPCA(B), PREA(P):  P
 
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