Protective efficacy demonstrated by PedvaxHIB in a high-risk population
In the Protective Efficacy Study, following the primary 2-dose regimen, the protective efficacy of lyophilized PedvaxHIB was estimated.
Efficacy results at 15 to 18 months of age after primary 2-dose regimen (N=3,486)
(95% CI, 57%–98%)
After additional follow-up of 2 years and 9 monthsb
(95% CI, 72%–99.99%)
in children under 18 months
(95% CI, 24%–100%)
in children under 18 months
PedvaxHIBc was initially evaluated in a randomized, double-blind, placebo-controlled study of Native American (Navajo) infants (N=3,486).
Each infant in this study received 2 doses of either placebo or lyophilized PedvaxHIB, with the first dose administered at a mean of 8 weeks of age and the second administered approximately 2 months later; DTP and OPV were administered concomitantly.
Protective efficacy in such high-risk populations would be expected to be predictive of efficacy in other populations.
A booster dose of PedvaxHIB is required in infants who complete the primary 2-dose regimen before 12 months of age. This booster dose will help maintain antibody levels during the first 2 years of life when children are at highest risk for invasive Hib disease.
- aEstimated from person-days at risk.
bSubjects in this portion of the study received 1 to 3 doses of PedvaxHIB.
cA lyophilized formulation was used in the study. A later study found the antibody response of Liquid PedvaxHIB to be comparable.
The antibody responses induced by each formulation of PedvaxHIB were similar.
CI=confidence interval; DTP=diphtheria and tetanus toxoids and pertussis [vaccine]; OPV=oral polio vaccine;
Hib=Haemophilus influenzae type b.
Indications and Usage for PedvaxHIB
PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] 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 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.
Because of the potential for immune tolerance, PedvaxHIB IS NOT RECOMMENDED FOR USE IN INFANTS YOUNGER THAN 6 WEEKS OF AGE.
Infants completing the primary 2-dose regimen before 12 months of age should receive a booster dose. (See Dosage and Administration)
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 or the diluent.
PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] 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 or the diluent.
As for any vaccine, adequate treatment provisions, including epinephrine, should be available for immediate use should an anaphylactoid reaction occur.
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.
There is insufficient evidence that PedvaxHIB given immediately after exposure to natural Haemophilus influenzae type b will prevent illness.
If PedvaxHIB is used in persons with malignancies or those receiving immunosuppressive therapy or who are otherwise immunocompromised, the expected immune response may not be obtained.
Animal reproduction studies have not been conducted with PedvaxHIB. Liquid PedvaxHIB is not recommended for use in individuals 6 years of age and older.
Geriatric use: This vaccine is NOT recommended for use in adult populations.
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.
The following additional adverse reactions have been reported with the use of the marketed vaccine: lymphadenopathy; rarely, angioedema; febrile seizures; sterile injection-site abscess.
Dosage and Administration for PedvaxHIB
PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] 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.
Infants born prematurely, regardless of birth weight, should be vaccinated at the same chronological age and according to the same schedule and precautions as full-term infants and children.
Children 15 months of age and older previously unvaccinated against Hib disease should receive a single 0.5 mL dose of vaccine.
PedvaxHIB may be interchanged with other licensed Haemophilus b conjugate vaccines for the primary and booster doses. If PedvaxHIB is given in a series with one of the other products licensed for infants, the recommended number of doses to complete the primary series is determined by the other product and not by PedvaxHIB. PedvaxHIB may be interchanged with other licensed Haemophilus b conjugate vaccines for the booster dose.
Before administering PedvaxHIB, please read the accompanying Prescribing Information.