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Pediatric Studies Characteristics - Detail
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Pediatrics
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 #:
3
Study Type:
Efficacy/Safety/Immunogenicity
Study Design:
Double-Blind/Placebo
No Patients:
2276
No Centers:
3
No Countries:
3
BPCA(B), PREA(P):
P
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