Quadracel
STN: BL 125525
Proper Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine
Tradename: Quadracel
Manufacturer: Sanofi Pasteur Limited
Indication:
- Active immunization against diphtheria, tetanus, pertussis and poliomyelitis. A single dose of Quadracel is approved as a fifth dose in the diphtheria, tetanus, pertussis (DTaP) vaccination series, and as a fourth or fifth dose in the inactivated poliovirus (IPV) vaccination series in children 4 through 6 years of age whose previous DTaP vaccine doses have been with Pentacel, DAPTACEL, and/or VAXELIS.
Product Information
- Package Insert - Quadracel (inactivated poliovirus component grown in MRC-5 cells)
- Package Insert – Quadracel (inactivated poliovirus component grown in Vero cells)
Support Documents
- July 21, 2022 Approval Letter - Quadracel
- February 17, 2021 Approval Letter - Quadracel
- December 19, 2019 Approval Letter - Quadracel
- June 11, 2019 Approval Letter - Quadracel
- Clinical Serology and Bioassay Review, and Approval Memo, March 1, 2015 - Quadracel
- Clinical Statistical Review - Quadracel
- Approval History, Letters, Reviews, and Related Documents - Quadracel
- Supporting Documents older than three years - Quadracel