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.

Storage and Handling

Condition on Arrival

  • Should not have been frozen; refrigerate on arrival.

Storage

  • Refrigerate immediately on arrival; store vaccine at 2°C to 8°C (36°F–46°F); DO NOT FREEZE.

Handling

  • Shake well before withdrawal and use. Thorough agitation is necessary to maintain suspension of the vaccine.
  • The vaccine should be used as supplied; no reconstitution is necessary.
  • Parenteral drug products should be inspected visually for extraneous particulate matter and discoloration prior to administration whenever solution and container permit. The vaccine is a slightly opaque, white suspension.

General Tips

  • If you have questions about the condition of the vaccine at the time of delivery, you should immediately place vaccine in recommended storage and call the Merck Vaccine Customer Center at 877.VAX.MERCK (877.829.6372).4
  • Rotate stock so that the shortest-dated vaccine is used first.4
  • Ensure that the refrigerator is plugged into an outlet in a protected area where it cannot be disconnected accidentally.4
  • It is important to use a separate sterile syringe and needle for each individual patient to prevent transmission of infectious agents from one person to another.5
  • Individual projects and state/local health department immunization programs may have specific requirements for providers who receive Vaccines for Children (VFC) vaccines or other vaccines purchased with public funds. Consult your immunization program for more information.4
  • For general questions concerning the proper storage and handling of Merck vaccines, please contact the Merck Vaccine Customer Helpline at 800.MERCK.90 (800.637.2590), Monday through Friday, 8:00 AM to 7:00 PM ET.
  • Before administering PedvaxHIB, please read the Prescribing Information.

Hib=Haemophilus influenzae type b.

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