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Pediatric Studies Characteristics - Detail
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Pediatrics
Pediatric Studies Characteristics
Detail
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Approval Date:
12/22/2010
Trade Name:
GARDASIL
Generic or Proper Name (*):
Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant*
Indications Studied:
Prevention of anal cancer caused by HPV types 16 and 18, and prevention of anal intraepithelial neoplasia (AIN) grades 1, 2, and 3 caused by HPV types included in the vaccine
Therapeutic Category:
Preventive Vaccine
Ages Studied:
16 26 years
Study #:
1
Study Type:
Efficacy/Safety/Immunogenicity
Study Design:
Double-blind/Controlled
No Patients:
598
No Centers:
71
No Countries:
18
BPCA(B), PREA(P):
P
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