IPOL

General Administration Information
For storage information, see specific product information within the How Supplied section.

-Inform the patient, parent, guardian, or responsible adult of the benefits and risks of the vaccine. Provide the Vaccine Information Statements from the manufacturer to the recipient or guardian before each immunization. These actions are required by the National Childhood Vaccine Injury Act of 1986.
-Record the manufacturer and lot number of the vaccine; date of administration; and the name, address, and title of the person who administered the vaccine in the recipient's permanent medical record. These actions are required by the National Childhood Vaccine Injury Act of 1986.

Route-Specific Administration

Injectable Administration
-Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. If particulate matter or discoloration exist, do not administer the vaccine.
-Inspect the vial or pre-filled syringe and its packaging prior to use for evidence of leakage; additionally, inspect the pre-filled syringe for evidence of premature activation of the plunger or a faulty seal tip. Do not use if these defects are present.
-Do not mix with any other vaccine in the same syringe or vial.
-When concomitant administration of other vaccines or immunoglobulin is required, they should be given with different syringes and at different injection sites.
Intramuscular Administration
-Use vaccine as supplied; reconstitution is not necessary. The vaccine is a clear, colorless solution.
-Administer shortly after preparation of the injection site.

Intramuscular (IM) Injection
-For vials, use a sterile syringe and needle to withdraw the vaccine from the vial. For prefilled syringes, attach a sterile needle.-For the majority of infants < 1 year, a 1-inch, 22- to 25-gauge needle is sufficient to penetrate thigh muscle.
-For children 1-2 years, a needle at least 1 inch long is preferred for administration into the thigh; a 5/8 inch needle is sufficient for administration into the deltoid if the skin is stretched flat and the needle is inserted at a 90 degree angle.
-For children >= 3 years, the needle size required for deltoid injection ranges from 5/8- to 1-inch.

-Inject intramuscularly into the anterolateral aspect of the mid-thigh (infants and young children) or the deltoid muscle of the upper arm (older children and adolescents). Do NOT administer in the gluteal muscle or other areas where there may be a major nerve trunk.

Subcutaneous Administration
-Use vaccine as supplied; reconstitution is not necessary. The vaccine is a clear, colorless solution.
-Use a sterile syringe and needle to withdraw solution from the vial. For prefilled syringes, attach a sterile needle. A 5/8-inch, 23- to 25-gauge needle is appropriate.
-Administer at a 45 degree angle into the subcutaneous tissue.-In infants < 1 year, administration into the anterolateral aspect of the thigh is preferred. The upper-outer triceps area may be used if necessary.
-In children >= 1 year of age and adolescents, inject into the upper-outer triceps area.

-Administer shortly after preparation of the injection site.

Report all adverse reactions to the Vaccine Adverse Event Reporting System (VAERS), as well as to the manufacturer. The toll-free number for VAERS is 1-800-822-7967. Educate the responsible adult(s) to promptly report any adverse reaction after vaccine administration to a health care provider.

The most frequently reported adverse reaction to poliovirus vaccine, inactivated, IPV is an injection site reaction (usually erythema, swelling and tenderness). Of patients that received an earlier formulation of the vaccine, 3.2% had erythema, 1% had induration, and 13% had pain within 48 hours of vaccine receipt. Among children 2-18 months of age that received the current formulation of IPV intramuscularly at 2, 4, and 18 months of age during 4 US clinical studies, 0-1.4% had erythema within 48 hours after the injection. More children had swelling (0-11.4%) or tenderness (0-29.4%). Skin rash at the injection site has been reported.

Systemic adverse events, including fever, irritability, fussiness, crying, or inconsolable crying, observed in infants and children who received poliovirus vaccine, inactivated, IPV during clinical studies are difficult to ascertain because the vaccine was given concomitantly with either whole-cell DTP or DTaP vaccines. In studies with an earlier formulation of IPV, fever >= 102 degrees F was reported in 38% of patients who received the vaccine concurrently with whole-cell DTP. During 4 US studies involving over 1300 infants and children who received the current IPV formulation at 2, 4, and 18 months of age, fever > 102.2 degrees F occurred within 48 hours following vaccination in 0-4.2% of patients; whole-cell DTP or DTaP were administered concomitantly at separate sites. During the same studies, irritability was observed in 8-64.5% of patients within 48 hours of vaccination. Within 72 hours vaccination with IPV, 1.4% of infants experienced inconsolable crying after dose 2 in the series (at 4 months of age); no patients had inconsolable crying following vaccination at 2 or 18 months of age. Agitation has been noted during post-marketing surveillance. Counsel patients to report any signs or symptoms of a systemic reaction to a health care provider.

Allergic reactions and anaphylactoid reactions, such as anaphylactic shock and angioedema, have been observed during post-marketing experience with poliovirus vaccine, inactivated, IPV. Serious allergic reactions usually occur within a few hours after vaccine receipt. The vaccine recipient may have difficulty breathing, wheezing, tachycardia, or dizziness. Rash (unspecified) and urticaria have also been noted with IPV use. Epinephrine injection (1:1000) and other appropriate agents should be available to control immediate allergic reactions. Development of a severe allergic reaction precludes subsequent IPV administration.

Anorexia and vomiting were observed in 1.3-16.6% and 0-2.8% of infants and children, respectively, that received poliovirus vaccine, inactivated, IPV with either whole-cell DTP or DTaP at 2, 4, and 18 months of age. Both anorexia and vomiting occurred at similar frequencies when whole-cell DTP was given alone.


Myalgia and arthralgia have been reported during post-marketing surveillance with poliovirus vaccine, inactivated, IPV. The frequency of occurrence or causal relationship to the vaccine cannot be reliably determined because the events are reported voluntarily from a population of uncertain size.

Lymphadenopathy has been observed during post-marketing experience with poliovirus vaccine, inactivated, IPV. A causal relationship to vaccine exposure is not established.

Drowsiness or sleepiness was observed in pediatric patients that received poliovirus vaccine, inactivated, IPV concurrently with whole-cell DTP during clinical trials. During 4 US clinical studies in infants and children 2 to 18 months of age (n = greater than 1,300), tiredness was observed in 4% to 60.7% of patients, with higher frequencies occurring in 2 month old patients compared to older children. Whole-cell DTP or DTaP was also administered concomitantly at separate injection sites. Adverse reactions were comparable in frequency and severity to those reported for whole-cell DTP when given alone. Seizures (including febrile seizures), headache, syncope, and paresthesias have been noted during postmarketing experience.

A causal relationship has not been established between poliovirus vaccine, inactivated, IPV and Guillain-Barre syndrome. However, temporal relationships between IPV administration and Guillain-Barre syndrome have been observed.

Prior to administration, inform the parent, guardian, or responsible adult of the benefits and risks of the vaccine, and provide the Vaccine Information Statement, accessible at the Centers for Disease Control and Prevention (CDC) website. These actions are required by the National Childhood Vaccine Injury Act of 1986. If a dose of poliovirus vaccine, inactivated, IPV has been previously given, question the parent or guardian about previous adverse reactions that may preclude further administration. Report all adverse reactions to the Vaccine Adverse Event Reporting System (VAERS), as well as the manufacturer. The toll-free number for VAERS is 1-800-822-7967. Educate the responsible adult(s) to promptly report any adverse reaction after vaccine administration to a health care provider.

Poliovirus vaccine, inactivated, IPV is contraindicated in patients who have had anaphylaxis or anaphylactic shock within 24 hours of a previous dose of the vaccine or any of its components, as well as in patients with streptomycin hypersensitivity, neomycin hypersensitivity, polymyxin hypersensitivity, formaldehyde hypersensitivity, or 2-phenoxyethanol hypersensitivity. These components are used in the manufacturing process and trace amounts may be present in the vaccine. With any biologic product, the prescriber or health care professional should take precautions to prevent allergic reactions. The health care professional should have immediate availability of epinephrine (1:1000) injection and other agents used in the treatment of severe anaphylaxis in the event of a serious allergic reaction.

Poliovirus vaccine, inactivated, IPV is administered intramuscularly or subcutaneously. Patients with thrombocytopenia, vitamin K deficiency, a coagulopathy (e.g., hemophilia), or those receiving anticoagulant therapy should be monitored closely when given IPV because bleeding can occur at the injection site.

Poliovirus vaccine, inactivated, IPV is contraindicated for use in patients with any acute, febrile illness. The Advisory Committee on Immunization Practices recommends that vaccinations be delayed during the course of a moderate or severe acute febrile illness and administered after the acute phase of illness has resolved. 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.

Patients with significant immunosuppression may not have an adequate antibody response to poliovirus vaccine, inactivated, IPV. Immunosuppressed persons may include patients with human immunodeficiency virus (HIV) infection; acquired immunodeficiency syndrome (AIDS); severe combined immunodeficiency (SCID); hypogammaglobulinemia; agammaglobulinemia; altered immune states due to generalized neoplastic disease; or an immune system compromised by radiation therapy or drug therapy (e.g., chemotherapy or corticosteroid therapy with greater than physiologic doses). Short-term (< 2 weeks) corticosteroid therapy or intra-articular, bursal, or tendon injections with corticosteroids should not be immunosuppressive. Patients vaccinated with IPV within 2 weeks before starting immunosuppressive therapy or while receiving immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after therapy is discontinued if immune competence has been restored. Hematopoietic stem cell transplant recipients should be revaccinated routinely 6 months after the transplant, regardless of the source of the transplanted stem cells.

Poliovirus vaccine, inactivated, IPV is only indicated for intramuscular or subcutaneous administration; do not give via intradermal or intravenous administration.

Safety and efficacy of the poliovirus vaccine, inactivated (IPV) have not been established in neonates and infants < 6 weeks of age.

Syncope has been associated with the administration of poliovirus vaccine, inactivated, IPV. Prior to administration of the vaccine, ensure procedures are in place to prevent injury secondary to falls.

Description: Poliovirus vaccine, inactivated, IPV is a parenteral non-infectious, sterile suspension of inactivated poliovirus type 1 (Mahoney), type 2 (MEF-1), and type 3 (Saukett). The vaccine promotes immunity to all 3 wild-types of poliovirus, which may produce a diversity of clinical manifestations including asymptomatic infection, nonspecific illness (e.g., sore throat or fever), meningitis, acute flaccid paralysis, and residual paralytic disease. The current IPV vaccine available in the US is sometimes referred to as enhanced-potency IPV; it has an increased amount of poliovirus antigen per dose compared to first generation formulations that were available before 1987. In 2000, the Advisory Committee on Immunization practices recommended exclusive use of IPV for routine immunization; previous immunization series consisted of oral poliovirus vaccine (OPV) or combinations of IPV and OPV. The decision to switch to IPV was primarily motivated by the association of OPV with rare cases of vaccine-associated paralytic poliomyelitis (VAPP), estimated to occur in 1 out of 2.4 million vaccine doses. Although OPV did provide benefits not demonstrated with IPV (enhanced intestinal immunity and boosting of immunity in unvaccinated contacts through shedding of the attenuated viruses), the lack of association with VAPP, elimination of wild-type poliovirus in the Western Hemisphere, and low risk of poliovirus importation into the US prompted the decision to switch to a IPV only series. IPV is indicated for active immunization of infants, children, and adolescents. IPV is FDA approved for use in infants as young as 6 weeks.

General Dosing Information
-Oral poliovirus vaccine (OPV) is not recommended for routine immunization in the US, and the vaccine is no longer distributed within the country.
-Interruption of the recommended schedule with a delay between doses should not interfere with the final immunity achieved with poliovirus vaccine, inactivated, IPV. There is no need to start a primary series over again, regardless of the time between doses.
-IPV may be simultaneously administered with other routine childhood vaccines in children for whom no specific contraindication exists at the time of the visit.
-If a patient previously experienced clinical poliomyelitis, vaccination with the series is still indicated, as the disease is usually due to infection by a single poliovirus type.
-Premature infants should be immunized according to their chronological age, regardless of birth weight.

For poliovirus prophylaxis:
Intramuscular or Subcutaneous dosage:
Infants and Children 2 months to 6 years: 0.5 mL IM or subcutaneously given at 2, 4, and 6 to 18 months, ideally at intervals of at least 8 weeks apart; the minimum interval between doses is 4 weeks. Administer a final booster dose of 0.5 mL IM or subcutaneously after the fourth birthday and at least 6 months after the previous dose; ideally, administration should occur between 4 to 6 years. Children younger than 4 years of age who have already received 4 doses of IPV should receive an additional booster dose at 4 to 6 years of age.

Maximum Dosage Limits:
-Neonates
Use not recommended.
-Infants
< 6 weeks: Use not recommended.
>= 6 weeks: 0.5 ml/dose IM or SC
-Children
0.5 ml/dose IM or SC.
-Adolescents
0.5 ml/dose IM or SC.

Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed. However, consult current immunization schedules for recommended vaccines for use in young dialysis patients; the ACIP states that all routine vaccinations are likely effective in patients with chronic renal disease.

*non-FDA-approved indication

Monograph content under development

Mechanism of Action: Poliovirus vaccine, inactivated, IPV provides long-term protection against poliovirus through humoral immunity by stimulating the immune system to produce serum antibodies against poliovirus wild-types 1, 2, and 3. Circulating antibodies persist for decades (possibly for life). IPV also induces secretory antibody (IgA) in the pharynx and gut. As poliovirus replicates in the oropharynx and intestinal tract, these antibodies assist with disease protection by shielding mucosal epithelial cells from viral penetration. Pharyngeal excretion of the virus (or shedding) is reduced, which can lower respiratory transmission of the virus; pharyngeal excretion of poliovirus type 1 was reduced from 75% in children with neutralizing antibodies at concentrations < 1:8 to 25% in children with neutralizing antibodies at concentrations > 1:64. Although some immunity in the lower intestinal tract develops, mucosal immunity produced by oral poliovirus (OPV) is superior. Therefore, if patients immunized with IPV ingest viable polioviruses, the viruses can shed in their stool. As the Western Hemisphere has been certified as free from indigenous wild poliovirus and the risk of importation into the US is low, the reduced intestinal immunity induced by IPV is clinically acceptable. Herd immunity is possible with IPV, including populations vaccinated only with IPV.

Pharmacokinetics: Poliovirus vaccine, inactivated, IPV is administered intramuscularly or subcutaneously. The pharmacokinetics of the vaccine are not well defined. The existence of antibodies against polioviruses is reliably associated with disease protection. A direct relationship exists between the antigenic content of IPV, the frequency of seroconversion, and resulting antibody titers. Detectable serum neutralizing antibodies to all three types of poliovirus have been reported for at least 10 years in children that received an IPV only immunization schedule.

Affected cytochrome P450 isoenzymes: none


-Special Populations
Pediatrics
Infants >= 2 months and Children <= 13 months
After 3 doses of IPV administered to 65 infants at 2, 4, and 12 months of age, development of serum neutralizing, nasopharyngeal neutralizing, and nasopharyngeal IgA antibodies was evaluated. Serum and nasopharyngeal secretions were collected 1 month after vaccination. After 2 doses, 96.4% of patients had detectable concentrations of serum neutralizing antibodies to poliovirus types 1 and 3, while 100% had antibodies to type 2. After 3 doses, 100% of patients had detectable serum antibodies to poliovirus types 2 and 3, while 96.2% had antibodies to type 1, with a final geometric mean titers of 1954.28, 5835.37 and 5187.4 for types 1, 2, and 3, respectively. Detectable nasopharyngeal neutralizing antibodies against poliovirus types 1, 2, and 3 were present in 43.4%, 60.4%, and 66% of patients, respectively after the third dose of IPV. Nasopharyngeal IgA antibodies to poliovirus were detected in 88.7% (type 1), 90.6% (type 2), and 88.7% (type 3) of patients after the third dose.