Indications and Usage

PedvaxHIB is indicated for routine vaccination against invasive disease caused by Haemophilus influenzae type b in infants and children 2 to 71 months of age. PedvaxHIB should not be used in infants <6 weeks of age.

PedvaxHIB will not protect against disease caused by Haemophilus influenzae other than type b or against other microorganisms that cause invasive disease such as meningitis or sepsis.

As with any vaccine, vaccination may not result in a protective antibody response in all individuals given the vaccine.

PedvaxHIB IS NOT RECOMMENDED FOR USE IN INFANTS YOUNGER THAN 6 WEEKS OF AGE.

Selected Safety Information for PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)]

PedvaxHIB is contraindicated in patients with hypersensitivity to any component of the vaccine. Persons who develop symptoms suggestive of hypersensitivity after an injection should not receive further injections of the vaccine.

Use caution when vaccinating latex-sensitive individuals since the vial stopper contains dry natural latex rubber that may cause allergic reactions.

As with other vaccines, PedvaxHIB may not induce protective antibody levels immediately following vaccination.

In clinical trials, the most frequently reported (>1%) adverse reactions, without regard to causality, were fever (≥101°F), irritability, sleepiness, injection-site pain/soreness, injection-site erythema (≤2.5 cm diameter), injection-site swelling/induration (≤2.5 cm diameter), unusual high-pitched crying, prolonged crying (>4 hours), diarrhea, vomiting, crying, pain, otitis media, rash, and upper respiratory infection.

1. Centers for Disease Control and Prevention (CDC). Recommended immunization schedules for persons aged 0 through 18 years—United States, 2016. http://www.cdc.gov/vaccines/schedules/downloads/
child/0-18yrs-child-combined-schedule.pdf. Effective January 1, 2016. Accessed February 8, 2016.
2.  ActHIB [package insert]. Swiftwater, PA: Sanofi Pasteur Inc.; 2015.
3.  Hiberix [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2016.
4.  Centers for Disease Control and Prevention (CDC). Vaccine Storage & Handling Toolkit. http://www.cdc.gov/vaccines/recs/storage/toolkit/
storage-handling-toolkit.pdf. Published May 2014. Accessed January 7, 2016.
5.  Centers for Disease Control and Prevention (CDC). Vaccine Administration. In: Hamborsky J, Kroger A, Wolfe S, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 13th ed. Washington, DC: Public Health Foundation; 2015:79–106.

Indications and Usage

PedvaxHIB is indicated for routine vaccination against invasive disease caused by Haemophilus influenzae type b in infants and children 2 to 71 months of age. PedvaxHIB should not be used in infants <6 weeks of age.

PedvaxHIB will not protect against disease caused by Haemophilus influenzae other than type b or against other microorganisms that cause invasive disease such as meningitis or sepsis.

As with any vaccine, vaccination may not result in a protective antibody response in all individuals given the vaccine.

PedvaxHIB IS NOT RECOMMENDED FOR USE IN INFANTS YOUNGER THAN 6 WEEKS OF AGE.

Selected Dosage and Administration

PedvaxHIB is administered in a 2-dose primary regimen before 14 months of age. Infants 2 to 14 months of age should receive a 0.5 mL dose of vaccine, ideally beginning at 2 months of age, followed by a 0.5 mL dose 2 months later (or as soon as possible thereafter). When the primary 2-dose regimen is completed before 12 months of age, a booster dose (0.5 mL) should be administered at 12 to 15 months, but not earlier than 2 months after the second dose.

Selected Safety Information for PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)]

PedvaxHIB is contraindicated in patients with hypersensitivity to any component of the vaccine. Persons who develop symptoms suggestive of hypersensitivity after an injection should not receive further injections of the vaccine.

Use caution when vaccinating latex-sensitive individuals since the vial stopper contains dry natural latex rubber that may cause allergic reactions.

As with other vaccines, PedvaxHIB may not induce protective antibody levels immediately following vaccination.

In clinical trials, the most frequently reported (>1%) adverse reactions, without regard to causality, were fever (≥101°F), irritability, sleepiness, injection-site pain/soreness, injection-site erythema (≤2.5 cm diameter), injection-site swelling/induration (≤2.5 cm diameter), unusual high-pitched crying, prolonged crying (>4 hours), diarrhea, vomiting, crying, pain, otitis media, rash, and upper respiratory infection.

VACC-1169702-0001 01/17