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Pediatric Studies Characteristics - Detail
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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:
6 weeks 5 years
Study #:
5
Study Type:
Safety/Tolerability/Immunogenicity
Study Design:
Double-blind/Controlled
No Patients:
247
No Centers:
19
No Countries:
1
BPCA(B), PREA(P):
P
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