Haemophilus b conjugate vaccine indications and usage
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]
Indications And Usage
HIBERIX® is indicated for active immunization as a booster dose for the prevention of invasive disease caused by Haemophilusinfluenzae type b. HIBERIX is approved for use in children 15 months through 4 years of age (prior to fifth birthday).
HIBERIX is to be used as a booster dose in children who have received a primary series with a Haemophilus b Conjugate Vaccine that is licensed for primary immunization. HIBERIX is not approved for primary immunization.
The evaluation of effectiveness of HIBERIX as a booster dose was based on immune responses in children using serological endpoints that predict protection from invasive disease due to H. influenzae type b [see Clinical Pharmacology and Clinical Studies ]. These protective antibody levels have not been evaluated in clinical trials in which a booster dose of HIBERIX is compared to a booster dose of a US-licensed Haemophilus b Conjugate Vaccine in children who previously received a primary series with a US-licensed Haemophilus b Conjugate Vaccine [see Clinical Studies ].[1]
References
Adapted from the FDA Package Insert.