药物信息为HIBERIX [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)]Solution for Intramuscular InjectionInitial U.S. Approval: 2009 (GlaxoSmithKline Biologicals SA): 1 INDICATIONS AND USAGE

HIBERIX^® is indicated for active immunization as a booster dose for the prevention of invasive disease caused by Haemophilus influenzae 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 (12.1) and Clinical Studies (14.1)]. 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 (14.1)].