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Food and Drug Administration Approval of Use of Haemophilus b Conjugate Vaccine for Infants

The Food and Drug Administration has approved the Haemophilus b Conjugate Vaccine (Diphtheria CRM 197 Protein Conjugate) manufactured by Praxis Biologics, Inc., and distributed as HibTITERTM by Lederle Laboratories (Pearl River, New York) for use in infants in a three-dose immunization series at 2, 4, and 6 months of age. Previously unvaccinated infants 7-11 months of age should receive two doses 2 months apart. Previously unvaccinated children 12-14 months of age should receive one dose; a booster dose after 15 months of age is recommended for these children. Previously unvaccinated children 15-60 months of age should receive a single dose and do not require a booster. In the United States, Haemophilus influenzae type b is the major cause of bacterial meningitis in children less than 5 years of age, with the peak incidence in children less than 1 year of age (1). The principal efficacy trial for this vaccine was conducted in approximately 60,000 infants in the Northern California Kaiser Permanente Health Plan (2);approximately half of those children received the vaccine. Twelve cases of H. influenzae type b invasive disease occurred in unvaccinated children, compared with no cases in fully vaccinated children, indicating an efficacy of 100%, with the lower limit of the 95% confidence interval equal to 68%. The Immunization Practices Advisory Committee (ACIP) is planning to issue a complete statement. Reported by: Center for Biologics Evaluation and Research, Food and Drug Administration. Center for Infectious Diseases; Center for Prevention Svcs, CDC.

References

  1. Schlech WF, Ward JI, Band JD, et al. Bacterial meningitis in the United States, 1978 through 1981: the National Bacterial Meningitis Surveillance Study. JAMA 1985;253:1749-54. 2. Black SB, Shinefield HR, Hiatt RA, et al. Efficacy of HbOC conjugate Haemophilus influenzae type b vaccine in a study population of 48,000 infants (Abstract). In: Program and abstracts of the 30th Interscience Conference on Antimicrobial Agents and Chemotherapy. Washington, DC: American Society for Microbiology, 1990.



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