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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:  CERVARIX
 
Generic or Proper Name (*):  Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant*
 
Indications Studied:  Prevention of genital warts caused by HPV 16 and 18
 
Therapeutic Category:  Preventive Vaccine
 
Ages Studied:  15-25 years
 
Study #:  4
 
Study Type:  Efficacy/Safety/Immunogenicity
 
Study Design:  Double-blind/Controlled
 
No Centers:  135
 
No Countries:  14
 
BPCA(B), PREA(P):  P
 
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