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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  02/24/2010
 
Trade Name:  Prevnar 13
 
Generic or Proper Name (*):  Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) *
 
Indications Studied:  Active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, and for the prevention of otitis media caused by serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F
 
Therapeutic Category:  Preventive Vaccine
 
Ages Studied:  7 - < 72 months
 
Study #:  3
 
Study Type:  Safety/Immunogenicity
 
Study Design:  Open Label
 
No Patients:  354
 
No Centers:  9
 
No Countries:  1
 
BPCA(B), PREA(P):  P
 
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