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Health / DPT vaccine / Toxoid / Sanofi Pasteur / Pertussis vaccine / Tetanus / Immunogenicity / Pertussis / DTAP / Vaccines / Medicine / Biology


Immunogenicity Review of Pentacel
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Company

Aventis Pasteur Limited / DTaP / SPL / U.S. 2 DAPTACEL DTaP / Sanofi Pasteur SA / Sanofi Pasteur Limited / /

Country

United States / Canada / Sweden / /

Event

FDA Phase / /

Facility

U.S. Serology bridge / Pertussis Serology Bridge / /

MedicalCondition

ug tetanus / Antigen Diphtheria / disease / invasive disease / pertussis / polio virus / Diphtheria / ug ug tetanus tetanus / tetanus / LF Tetanus / poliomyelitis / polio / polio virus serotypes / Polio virus type / acellular pertussis / same diphtheria / LF Diphtheria / /

MedicalTreatment

immunization / Active immunization / vaccination / /

Organization

Research office of Vaccines Research / Vaccines Research and Review Center for Biologics Evaluation and Research Food and Drug Administration Subject / Vaccines Research and Review Division of Vaccines and Related Product Applications Date / Vaccines Clinical Trials Branch Division of Vaccines / Food and Drug Administration / Food and Drug Administration Center for Biologics Evaluation / Vaccines and Related Product Applications office of Vaccines Research / D. Scientific Reviewer Division of Vaccines / Vaccines Research and Review Center for Biologics Evaluation / European Union / Division of Vaccines / /

Person

Douglas Pratt / Code Theresa Finn / D. Edward Wolfgang / Karen Farizo / /

Position

Immunogenicity Executive / General / /

Product

This / Efficacy Supplement / Pertussis Vaccine / DAPTACEL BLA Supplement / Acellular Pertussis Vaccine / This supplement / /

Technology

3.1 Applicants Protocol / antibodies / pdf / /

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