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 younger than 6 weeks of age.

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

As with any vaccine, the use of PedvaxHIB may not result in a protective antibody response in all vaccinees; PedvaxHIB may not induce protective antibody levels immediately following vaccination.

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.

Before administering PedvaxHIB, please read the Prescribing Information.

PedvaxHIB is a registered trademark of Merck & Co., Inc.