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Health / Pharmacology / DPT vaccine / Pertussis vaccine / DTAP / Pertussis / Vaccination schedule / Tetanus / Sanofi Pasteur / Vaccines / Medicine / Bacterial diseases


Summary Basis for Regulatory Action - Quadracel
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Company

Sanofi-Pasteur Ltd / /

Country

United States / Canada / Mexico / /

Event

FDA Phase / /

Facility

Facilities Review/Inspection The facility / Pharmacovigilance Review Bioresearch Monitoring Review Facility / /

IndustryTerm

manufacturing documentation / lot release protocol / manufacturing information / manufacturing process / /

MedicalCondition

Immunogenicity Acellular Pertussis / pertussis / tetanus toxoid acellular pertussis / pertussis vaccination / Diphtheria / tetanus / units/mL Tetanus / poliomyelitis / poliomyelitis disease / same acellular pertussis / units/mL Diphtheria / acellular pertussis / MS / /

MedicalTreatment

vaccination / immunization schedule / /

Organization

Offices Signatory Authority / /

Person

Marion Gruber / Tod Merkel / Leslie Wagner / Karen Campbell / Juan Arciniega / Donald Ertel / Patricia Rohan / Dennis Cato / Tahir Malik / Sonny Saini / Sarah Browne / Lot Release / Aluminum Phosphate (Adjuvant) / Zhong Gao / Ghideon Solomon / James Keller / Matthew Steele / /

Position

Director / Office / /

Product

Pentacel vaccine / Pentacel / Diphtheria / /

Technology

submitted Lot Release Protocol / lot release protocol / /

SocialTag