Food and Drug Administration

Vaccines and Related Biological Products Advisory Committee

March 15, 2005

Briefing Information

FDA Clinical Briefing Document for Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed Boostrix™, Dr. Ann Schwartz, MD (PDF)

FDA Statistical Review and Evaluation - Boostrix™ (PDF)

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

GlaxoSmithKline - Boostrix™ (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed, Tdap) (PDF)

FDA Clinical Briefing Document for Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap, ADACEL™), Dr. ChrisAnna Mink, MD (PDF)

Corrections to Errata in the FDA Clinical Briefing Document, Dr. ChriAnna Mink, MD (HTM) (PDF) (Word)

FDA Statistical Review and Evaluation, Dr. Henry Hsu, PhD (HTM) (PDF) (Word)

Changes/Corrections to the FDA Statistical Briefing Document (HTM) (PDF) (Word)

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Aventis - ADACEL™ Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed: Tdap (PDF)