Compared to: HibTITER (a registered trademark
of Wyeth Pharmaceuticals, Inc.), ActHIB (a registered trademark
of Sanofi Pasteur Pharmaceuticals SA), and OmniHib (a registered
trademark of GlaxoSmithKline Biologicals S.A.).
e
While the anti-PRP level associated with
protection using conjugated vaccines
has not yet been determined, the
level of anti-PRP associated with protection in studies using bacterial polysaccharide
immune globulin or nonconjugated PRP vaccines ranged from >0.15 mcg/mL
to >1.0
mcg/mL.
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.
Select safety information
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.
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.
References: 1. American
Academy of Pediatrics Committee on Infectious Diseases. Haemophilus
influenzae type
b conjugate
vaccines: recommendations
for immunization with recently and previously licensed vaccines.
Pediatrics. 1993;92:480–488. 2. Data
available on request from Merck & Co., Inc., Professional
ServicesDAP, WP1-27, PO Box 4, West Point, PA 19486-0004.
Please specify information
package
20703489(1)-PED.
PedvaxHIB is a registered
trademark of Merck & Co., Inc.