General Information

Hiberix is a non-infectious vaccine used to prevent Haemophilus influenzae type b (Hib) infection in children. The vaccine works by causing the body to produce its own protection (antibodies) against the disease.

Hiberix is specifically indicated for active immunization as a booster dose for the prevention of invasive disease caused by Haemophilus influenzae type b for use in children 15 months through 4 years of age.

Hiberix is supplied as a solution for reconstitution designed for intramuscular administration. The recommended dose is 0.5-mL by intramuscular injection into the anterolateral aspect of the thigh or deltoid. 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.

Mechanism of Action

Hiberix is a non-infectious vaccine used to prevent Haemophilus influenzae type b (Hib) infection in children. The vaccine works by causing the body to produce its own protection (antibodies) against the disease.

Side Effects

Adverse events associated with the use of Hiberix may include, but are not limited to, the following:

• Injection site reactions
• Fever
• Fussiness
• Loss of appetite
• Restlessness
• Sleepiness
• Diarrhea

Clinical Trial Results

The FDA approval of Hiberix was based on six international clinical studies in 415 pediatrics, aged 12 to 23 months, which evaluated the immune response to Hiberix when administered as a booster dose. Antibodies to PRP were measured in sera obtained immediately prior to and 1 month after booster vaccination with Hiberix. Results from three of these trials are as follows:

Study One
This Canadian study enrolled 42 children 16 to 18 months of age who previously received 3 doses of DTaP-HBV-IPV and Haemophilus b Conjugate Vaccine (manufactured by Sanofi Pasteur SA). The booster dose of Hiberix was co-administered with DTaP-HBV-IPV. In this study, pre-vaccination sera may have been obtained up to 1 week prior to booster vaccination with Hiberix. The Anti-PRP GMC (mcg/mL) pre-Hiberix booster was 0.46 and post-Hiberix booster was 59.07. The % Anti-PRP &gr;0.15 mcg/mL was 76.2% pre-Hiberix boost and 100% post-Hiberix boost. The % Anti-PRP ≥1.0 mcg/mL was 35.7% pre-boost and 97.6 post-boost.

Study Two
This Canadian study enrolled 64 children 16 to 19 months of age who previously received 3 doses of DTaP-IPV and Hiberix. The booster dose of HIBERIX was co-administered with DTaP-IPV. The Anti-PRP GMC (mcg/mL) pre-Hiberix booster was 0.25 and post-Hiberix booster was 47.78. The % Anti-PRP &gr;0.15 mcg/mL was 71.4% pre-Hiberix boost and 100% post-Hiberix boost. The % Anti-PRP ≥1.0 mcg/mL was 12.7% pre-boost and 100% post-boost.

Study Three
This German study enrolled 108 children 16 to 23 months of age who previously received 3 doses of DTaP-HBV (GlaxoSmithKline Biologicals, not licensed in the US) and Hiberix (not approved for primary immunization in the US). The booster dose of Hiberix was co-administered with DTaP-HBV. The Anti-PRP GMC (mcg/mL) pre-Hiberix booster was 0.59 and post-Hiberix booster was 96.12. The % Anti-PRP &gr;0.15 mcg/mL was 77.8% pre-Hiberix boost and 100% post-Hiberix boost. The % Anti-PRP ≥1.0 mcg/mL was 32.4% pre-boost and 100% post-boost.