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
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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