Vaccine Information: PedvaxHIB (Page 2 of 4)

Interchangeability of Licensed Haemophilus b Conjugate Vaccines and PedvaxHIB

Published studies have examined the interchangeability of other licensed Haemophilus b Conjugate Vaccines and PedvaxHIB.{42,43,44,45,52} According to the American Academy of Pediatrics, excellent immune responses have been achieved when different vaccines have been interchanged in the primary series. If PedvaxHIB is given in a series with one of the other products licensed for infants, the recommended number of doses to complete the 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.{52}

Use with Other Vaccines

Results from clinical studies indicate that Liquid PedvaxHIB can be administered concomitantly with DTP, OPV, eIPV (enhanced inactivated poliovirus vaccine), VARIVAX® [Varicella Virus Vaccine Live (Oka/Merck)], M-M-R® II (Measles, Mumps, and Rubella Virus Vaccine Live) or RECOMBIVAX HB® [Hepatitis B Vaccine (Recombinant)].{33} No impairment of immune response to individual tested vaccine antigens was demonstrated.

The type, frequency and severity of adverse experiences observed in these studies with PedvaxHIB were similar to those seen when the other vaccines were given alone.

In addition, a PRP-OMPC-containing product, COMVAX® [Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine], was given concomitantly with a booster dose of DTaP [diphtheria, tetanus, acellular pertussis] at approximately 15 months of age, using separate sites and syringes for injectable vaccines. No impairment of immune response to these individually tested vaccine antigens was demonstrated. COMVAX has also been administered concomitantly with the primary series of DTaP to a limited number of infants. PRP antibody responses are satisfactory for COMVAX, but immune responses are currently unavailable for DTaP (see Manufacturer’s Product Circular for COMVAX). No serious vaccine-related adverse events were reported.{33}

INDICATIONS AND USAGE

Liquid 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.

Liquid 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 with Liquid PedvaxHIB may not result in a protective antibody response in all individuals given the vaccine.

BECAUSE OF THE POTENTIAL FOR IMMUNE TOLERANCE, Liquid PedvaxHIB IS NOT RECOMMENDED FOR USE IN INFANTS YOUNGER THAN 6 WEEKS OF AGE. (See PRECAUTIONS.)

Revaccination

Infants completing the primary two-dose regimen before 12 months of age should receive a booster dose (see DOSAGE AND ADMINISTRATION).

CONTRAINDICATIONS

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.

PRECAUTIONS

General

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.

Special care should be taken to ensure that the injection does not enter a blood vessel.

It is important to use a separate sterile syringe and needle for each patient to prevent transmission of hepatitis B or other infectious agents from one person to another.

As with other vaccines, Liquid PedvaxHIB may not induce protective antibody levels immediately following vaccination.

As reported with Haemophilus b Polysaccharide Vaccine{36} and another Haemophilus b Conjugate Vaccine{37}, cases of Hib disease may occur in the week after vaccination, prior to the onset of the protective effects of the vaccines.

There is insufficient evidence that Liquid PedvaxHIB given immediately after exposure to natural Haemophilus influenzae type b will prevent illness.

The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and on the etiology of the disease. The Advisory Committee on Immunization Practices (ACIP) has recommended that vaccination should be delayed during the course of an acute febrile illness. All vaccines can be administered to persons with minor illnesses such as diarrhea, mild upper-respiratory infection with or without low-grade fever, or other low-grade febrile illness. Persons with moderate or severe febrile illness should be vaccinated as soon as they have recovered from the acute phase of the illness.{46}

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.

Instructions to Healthcare Provider

The healthcare provider should determine the current health status and previous vaccination history of the vaccinee.

The healthcare provider should question the patient, parent, or guardian about reactions to a previous dose of PedvaxHIB or other Haemophilus b Conjugate Vaccines.

Information for Patients

The healthcare provider should provide the vaccine information required to be given with each vaccination to the patient, parent, or guardian.

The healthcare provider should inform the patient, parent, or guardian of the benefits and risks associated with vaccination. For risks associated with vaccination, see ADVERSE REACTIONS.

Patients, parents, and guardians should be instructed to report any serious adverse reactions to their healthcare provider who in turn should report such events to the U. S. Department of Health and Human Services through the Vaccine Adverse Event Reporting System (VAERS), 1-800-822-7967.{47}

Laboratory Test Interactions

Sensitive tests (e.g., Latex Agglutination Kits) may detect PRP derived from the vaccine in urine of some vaccinees for at least 30 days following vaccination with lyophilized PedvaxHIB;{38} in clinical studies with lyophilized PedvaxHIB, such children demonstrated normal immune response to the vaccine.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Liquid PedvaxHIB has not been evaluated for carcinogenic or mutagenic potential, or potential to impair fertility.

Pregnancy

Animal reproduction studies have not been conducted with PedvaxHIB. Liquid PedvaxHIB is not recommended for use in individuals 6 years of age and older.

Pediatric Use

Safety and effectiveness in infants below the age of 2 months and in children 6 years of age and older have not been established. In addition, Liquid PedvaxHIB should not be used in infants younger than 6 weeks of age because this will lead to a reduced anti-PRP response and may lead to immune tolerance (impaired ability to respond to subsequent exposure to the PRP antigen).{49-51} Liquid PedvaxHIB is not recommended for use in individuals 6 years of age and older because they are generally not at risk of Hib disease.

Geriatric Use

This vaccine is NOT recommended for use in adult populations.

ADVERSE REACTIONS

Liquid PedvaxHIB

In a multicenter clinical study (n=903) comparing the effects of Liquid PedvaxHIB with those of lyophilized PedvaxHIB, 1,699 doses of Liquid PedvaxHIB were administered to 678 healthy infants 2 to 6 months of age from the general U.S. population. DTP and OPV were administered concomitantly to most subjects. Both formulations of PedvaxHIB were generally well tolerated and no serious vaccine-related adverse reactions were reported.

During a three-day period following primary vaccination with Liquid PedvaxHIB in these infants, the most frequently reported (>1%) adverse reactions, without regard to causality, excluding those shown in TABLE 5, in decreasing order of frequency, were: irritability, sleepiness, injection site pain/soreness, injection site erythema (≤2.5 cm diameter, see also TABLE 5), injection site swelling/induration (≤2.5 cm diameter, see also TABLE 5), unusual high-pitched crying, prolonged crying (>4 hr), diarrhea, vomiting, crying, pain, otitis media, rash, and upper respiratory infection.

Selected objective observations reported by parents over a 48-hour period in these infants following primary vaccination with Liquid PedvaxHIB are summarized in TABLE 5.

TABLE 5: Fever or Local Reactions in Subjects First Vaccinated at 2 to 6 Months of Age with Liquid PedvaxHIB *
Post-Dose 1 (hr) Post-Dose 2 (hr)
Reaction No. of Subjects Evaluated 6 24 48 No. of Subjects Evaluated 6 24 48
*
DTP and OPV were administered concomitantly to most subjects.
Fever was also measured by another method or reported as normal for an additional 345 infants after dose 1 and for an additional 249 infants after dose 2; however, these data are not included in this table.
Percentage Percentage
Fever >38.3°C (≥101°F) Rectal 222 18.1 4.4 0.5 206 14.1 9.4 2.8
Erythema >2.5 cm diameter 674 2.2 1.0 0.5 562 1.6 1.1 0.4
Swelling >2.5 cm diameter 674 2.5 1.9 0.9 562 0.9 0.9 1.3

Adverse reactions during a three-day period following administration of the booster dose were generally similar in type and frequency to those seen following primary vaccination.

VxLabels.com provides trustworthy package insert and label information about marketed drugs and vaccines as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VxLabels.com. Every individual vaccine label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Vaccine Sections

Vaccine Information by RSS

As the leading independent provider of trustworthy vaccine information, our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. VxLabels.com provides the full vaccine subset of the FDA's repository. Vaccine information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.