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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  04/03/2008
 
Trade Name:  ROTARIX
 
Generic or Proper Name (*):  Rotavirus Vaccine, Live, Oral*
 
Indications Studied:  Prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9)
 
Therapeutic Category:  Preventive Vaccine
 
Ages Studied:  6 - 24 weeks
 
Study #:  5
 
Study Type:  Safety/Immunogenicity
 
Study Design:  Double-Blind/Placebo
 
No Patients:  854
 
No Centers:  7
 
No Countries:  3
 
BPCA(B), PREA(P):  P
 
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