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Notice to Readers
Unlicensed Use of Combination of Haemophilus
influenzae type b Conjugate Vaccine and Diphtheria and Tetanus
Toxoid and Acellular Pertussis Vaccine for Infants
The only licensed combination vaccine containing Haemophilus
influenzae type b (Hib) conjugate vaccine and diphtheria and
tetanus toxoid and acellular pertussis vaccine (DTaP) is for use in
children aged 15-18 months. The Food and Drug Administration and
CDC's National Immunization Program have received reports from
state health departments that in certain clinical settings,
licensed Hib conjugate vaccines and DTaP vaccines are being
combined for administration as a single injection in infants aged
2, 4, and 6 months. These vaccines (DTaP/Hib) have not been
licensed for combination use in the primary vaccination series in
infants. Clinical studies in infants conducted under
Investigational New Drug applications have demonstrated that using
some combination vaccine products containing Hib vaccine may induce
a suboptimal immune response to the Hib vaccine component.
Additional information about further vaccination actions that may
be required for the infant who received an unlicensed DTaP/Hib
combination product is available from CDC's Immunization Hotline,
telephone (800) 232-2522.
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