January 27, 2000

Briefing Information

Clinical Experience at Aventis Pasteur with Combination Acellular DTP and Hib Conjugate Vaccines, Carlton K Meschievitz, MD, MPH, Aventis Pasteur

Antibody responses to Hib polysaccharide conjugates when used with DtaP, Helen Cicirello, Peter C. Fusco, and Jo White, North American Vaccine, Inc., Columbia, MD

Antibody Responses to Hib Polysaccharide when used with NAVA DTaP, North American Vaccine Inc (NAVA)

Interference with Hib responses in combination vaccine and with concomitant IPV administration, Dr. Margaret Rennels

"Brief Reports - Enhanced Immunogenicity of a Sequential Haemophilus Influenzae Type B Vaccine Schedule in Alaska Native Infants," The Pediatric Infectious Disease Journal, V 18, No. 11, Nov. 1999, p 1023-1024.*

Lucher, Lynne A. PhD, et al, "Special Feature from the CDC … The Challenge of Ongoing2 Haemophilus Influenzae Type B Carriage and Transmission in Alaska," Alaska Medicine, Vol. 41, No. 3, July/Aug/Sept 1999, p 61-68.*

Gaiil, Karen, etc. "Reemergence of Invasive Haemophilus Influenzae Type b Disease in a Well-Vaccinated Population in Remote Alaska," JID., 179, January 1999, p 103-106.*

Abstract for FDA-meeting, Washington, January 17, 2000, DTPa Hib Combination Vaccines: Population-Based Evaluation of Vaccine, Effectiveness-results after 18 months of surveillance, H.J. Schmitt1, R. von Kries2, B. Hassenpflug1, M. Hermann2, W. Niessing3, A. Siedler3, J. Weil4

Hib antibodies and field efficacy of Hib conjugate vaccines in the United Kingdom, Dr. Paul T Heath, St. George's Hopital Medical School and St. George's Vaccine Institute

Eskola, Juhani, et al, "Review: Combined vaccination of Haemophilus Influenzae type b conjugate and diphtheria-tetanus-pertussis containing acellular/pertussis," The Lancet, Vol 354, December 11, 1999, p 2063-2068.*

Trial Design and Statistical Analysis of Immune Response to Combination Vaccines, Amelia Dale Horne, Dr.P.H., CBER/FDA

Combination Vaccines Containing Haemophilus influenzae type b (Hib): Immune Correlates of Protection Against Invasive Hib Disease and Potential Clinical Significance of Reduced Anti-PRP Polysaccharide Responses, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA

Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies

Guess, Harry A. "Combination Vaccines: Issues in Evaluation of Effectiveness and Safety," Epidemiological Reviews, Vol 21, No. 1, p 89-95.*

Health, Paul T, "Haemophilus Influenzae type b conjugate vaccines: a review of efficacy data," Pediatric Infectious Disease Journal, 1998, Vol. 17, No. 9, p. S117-22.*

Decker, Michael D., MD et al, " Haemophilus Influenzae type b vaccines: history, choice and comparisons," Pediatric Infectious Disease Journal, 1998, Vol. 17, No. 9, p. S113-6.*

Zepp, F, et al "Immunology/Allergology: Evidence for induction of polysaccharide specific B-cell-memory in the 1st year of life: plain

Haemophilus Influenzae type b - PRP (Hib) boosters children primed with a tetanus-conjugate Hib-DTPa-HBV combinated vaccines," European Journal of Pediatrics, 1997 Vol 156, p 18-14.*

Granoff, D M, et al, "Induction of Immunologic Memory in Infants Primed with Haemophilus Influenzae type b Conjugate Vaccines," Journal of Infectious Diseases, 1993, Vol. 168, p 663-71.*

Goldblatt, D, et al, "antibody Avidity as a Surrogate Marker of Successful Priming by Haemophilus Influenzae type b Conjugate Vaccines following Infant Immunization," Journal of Infectious Diseases, 1998, Vol. 177, p 1112-5.*

Wenger, Jay D., MD, "Epidemiology of Haemophilus Influenzae type b disease and impact of Haemophilus Influenzae type b conjugate vaccines in the United States and Canada," Pediatric Infectious Disease Journal, 1998, Vol. 17, No. 9, p. S132-6.*

Jafari, Hamid S. et al, "Abstract - Efficacy of Haemophilus Influenzae type b Conjugate Vaccines and Persistence of Disease in Disadvantaged Populations," American Journal of Public Health, March 1999, Vol. 89, No. 3, p. 364-8.*

Comparative Immunogenicity Between Hib Combination Vaccines and Separately Injected Controls, FDA

Clinical impact of the DTPa-Hib interference, Juhani Eskola, KTL, Finland

Antibody Responses to a Combined DtaP/Hib Vaccine with OPV or IPV; Variability of Anti-PRP Responses at Different Clinical Sites, Daum et al.


 Development of DTaP-based Hib conjugate combination vaccines: SmithKline Beecham


*This document contains copyrighted material. The document may be viewed at: Dockets Management Branch, Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852