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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail

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Approval Date:  04/22/2011
 
Trade Name:  Menactra
 
Generic or Proper Name (*):  Meningococcal Polysaccharide (Serogroups A, C, Y and W-135) Diphtheria Toxoid Conjugate Vaccine)*
 
Indications Studied:  Active immunization of individuals 9 months through 55 years of age for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135
 
Therapeutic Category:  Preventive Vaccine
 
Ages Studied:  9 - <13 months
 
Study #:  1
 
Study Type:  Safety/Immunogenicity
 
Study Design:  Randomized/Open label, Controlled
 
No Patients:  1257
 
No Centers:  71
 
No Countries:  1
 
BPCA(B), PREA(P):  P
 
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