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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail

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Approval Date:  01/28/2011
 
Trade Name:  MENVEO
 
Generic or Proper Name (*):  Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine*
 
Indications Studied:  Active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135
 
Therapeutic Category:  Preventive Vaccine
 
Ages Studied:  2 - <11 years
 
Study #:  1
 
Study Type:  Safety/Immunogenicity
 
Study Design:  Open Label
 
No Patients:  2907
 
No Centers:  62
 
No Countries:  2
 
BPCA(B), PREA(P):  P
 
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