VACCINES & RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE
March 7, 2001
Briefing Information
Session 2
InfanrixDTPa-HepB-IPV from SmithKline Beecham Biologicals pdf
Disclaimer
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