March 7, 2001

Briefing Information

Session 2

InfanrixDTPa-HepB-IPV from SmithKline Beecham Biologicals   pdf


The statements contained in this document 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.

Food and Drug Administration

BLA Ref. No. 99-0800, Clinical Review, Leslie K Ball, MD, CBER   doc   pdf

Appendix 3: FDA Guidance for Industry.  Evaluation of Combination Vaccines for Preventable Diseases:  Production, Testing and Clinical Studies, April 1997   pdf   txt

Appendix 4: Package Insert:  Infanrix   pdf

Appendix 5:  Package Insert:  Engerix-B   pdf

Appendix 6:  Package Insert:  Prevnar   pdf

Appendix 7:  Recomended Childhood Immunization Schedule United States, January- December 2001   pdf

Appendix 8:  Combination Vaccines fo Childhood Immunizations:  MMWR. 1999: 48(RR-05): 1-15   pdf

Appendix 9:  Public Health Service Recommendations for the Use of Vaccines manufactured with Bovine-Derived Materials.  MMWR. 2000:49;1137-8   htm