TM Owner Merck & Co.
PedvaxHIB 7.5mcg/0.5mL Injection
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Indications & Clinical Uses
- PedvaxHIB 7.5 mcg/0.5 mL is a Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate), manufactured by Merck, that protects against invasive disease caused by Haemophilus influenzae type b (Hib), including meningitis, epiglottitis, and bloodstream infection.
- It is approved in the United States for routine active immunisation of infants and children aged 2 through 71 months.
- The primary series is two 0.5 mL intramuscular doses given 2 months apart, usually at 2 and 4 months of age, with a booster dose at 12 to 15 months if the primary series was completed before 12 months; children who start vaccination between 15 and 71 months need only a single dose.
- It is not recommended before 6 weeks of age, and is given by a healthcare provider only, never at home.
Side Effects
- The most common reactions are injection-site pain, soreness, redness and swelling, along with fever above 38.3°C (reported in up to about 18% of infants after the first dose), irritability, sleepiness, unusual crying, diarrhoea and vomiting.
- Most reactions are mild and resolve within a few days.
- There is no boxed warning on the current PedvaxHIB label.
- As with any vaccine, a severe allergic reaction (anaphylaxis) is possible but rare and would typically occur within minutes of the injection, with symptoms such as difficulty breathing, swelling of the face or throat, or hives.
- Seek urgent medical attention for a high or persistent fever, seizures, or any sign of a severe allergic reaction after vaccination.
Precautions & Warnings
- PedvaxHIB is contraindicated in a child who has had a severe allergic reaction to a previous dose or to any vaccine component or diluent.
- The vial stopper contains natural rubber latex, so caution is needed in latex-sensitive individuals.
- Vaccination should generally be postponed during an acute moderate or severe febrile illness.
- Because protective antibody levels take time to develop, Hib disease can still occur in the days immediately after vaccination before immunity is established.
- Children with immune-compromising conditions, including those on immunosuppressive therapy, may have a reduced immune response to the vaccine and should be counselled accordingly.
- It is for intramuscular injection into the anterolateral thigh (infants) or the deltoid (older children) only, and must never be given intravenously.
- Store refrigerated at 2°C to 8°C; do not freeze.
Avoid Interactions
- PedvaxHIB can be given at the same visit as other routine childhood vaccines, including DTP/DTaP, oral or inactivated polio vaccine, MMR, varicella and hepatitis B vaccines, provided each vaccine is given at a separate injection site; it should not be mixed with any other vaccine or drug in the same syringe.
- Children receiving immunosuppressive therapy, chemotherapy, or high-dose corticosteroids may have a reduced antibody response and this should be discussed with the healthcare provider before vaccination.
- Tell the healthcare provider about all vaccines and medicines the child has recently received or is currently receiving so that the immunisation schedule can be planned appropriately.
References
Frequently Asked Questions
PedvaxHIB protects infants and young children against invasive disease caused by Haemophilus influenzae type b (Hib), including meningitis and bloodstream infection. It is approved for children aged 2 through 71 months in the United States.
Most infants get two doses, 2 months apart, starting around 2 months of age, plus a booster at 12 to 15 months. Children starting between 15 and 71 months need only one dose. Each dose is an intramuscular injection given by a healthcare provider.
Injection-site pain, redness and swelling are common, along with fever, fussiness, sleepiness and reduced appetite. Most reactions are mild. Seek urgent care for a high fever, seizures, or signs of a severe allergic reaction like swelling or breathing trouble.
A child who has had a severe allergic reaction to a previous dose or to any vaccine ingredient should not receive PedvaxHIB. Tell the provider about latex allergy, since the vial stopper contains natural rubber latex, and postpone vaccination during a significant fever.
Yes, PedvaxHIB can be given during the same visit as DTaP, polio, MMR, varicella and hepatitis B vaccines, each at a different injection site. It should never be mixed with another vaccine or medicine in the same syringe.
No, it takes time for the immune system to build protection after vaccination, so a child can still develop Hib disease in the days just after a dose. Completing the full recommended schedule gives the best long-term protection.
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