IPOL®, Poliovirus Vaccine Inactivated, produced by Sanofi Pasteur SA, is a sterile suspension of three types of poliovirus: Type 1 (Mahoney), Type 2 (MEF-1), and Type 3 (Saukett). IPOL vaccine is a highly purified, inactivated poliovirus vaccine with enhanced potency. Each of the three strains of poliovirus is individually grown in vero cells, a continuous line of monkey kidney cells cultivated on microcarriers.^1,2 The cells are grown in Eagle MEM modified medium, supplemented with newborn calf serum tested for adventitious agents prior to use, originated from countries free of bovine spongiform encephalopathy. For viral growth the culture medium is replaced by M-199, without calf serum. This culture technique and improvements in purification, concentration and standardization of poliovirus antigen produce a more potent and consistent immunogenic vaccine than the inactivated poliovirus vaccine (IPV) available in the US prior to 1988.^3,4

After clarification and filtration, viral suspensions are concentrated by ultrafiltration, and purified by three liquid chromatography steps; one column of anion exchanger, one column of gel filtration and again one column of anion exchanger. After re-equilibration of the purified viral suspension, with Medium M-199 and adjustment of the antigen titer, the monovalent viral suspensions are inactivated at +37°C for at least 12 days with 1:4000 formalin.

Each dose (0.5 mL) of trivalent vaccine is formulated to contain 40 D antigen units of Type 1, 8 D antigen units of Type 2, and 32 D antigen units of Type 3 poliovirus. For each lot of IPOL vaccine, D-antigen content is determined in vitro using the D-antigen ELISA assay and immunogenicity is determined by in vivo testing in animals. IPOL vaccine is produced from vaccine concentrates diluted with M-199 medium. Also present are 0.5% of 2-phenoxyethanol and a maximum of 0.02% of formaldehyde per dose as preservatives. Neomycin, streptomycin and polymyxin B are used in vaccine production, and although purification procedures eliminate measurable amounts, less than 5 ng neomycin, 200 ng streptomycin and 25 ng polymyxin B per dose may still be present. The residual calf serum protein is less than 1 ppm in the final vaccine.

The vaccine is clear and colorless and should be administered intramuscularly or subcutaneously.

REFERENCES

1. van Wezel AL, et al. Inactivated poliovirus vaccine: Current production methods and new developments. Rev Infect Dis 6 (Suppl 2): S335-S340, 1984

2. Montagnon BJ, et al. Industrial scale production of inactivated poliovirus vaccine prepared by culture of Vero cells on microcarrier. Rev Infect Dis 6 (Suppl 2): S341-S344, 1984

3. McBean AM, et al. Serologic response to oral polio vaccine and enhanced-potency inactivated polio vaccines. Am J Epidemiol 128: 615-628, 1988

4. Murdin AD, et al. Inactivated poliovirus vaccine: past and present experience. Vaccine 8: 735-746, 1996

Last updated on RxList: 2/20/2009

IPOL vaccine is indicated for active immunization of infants (as young as 6 weeks of age), children and adults for the prevention of poliomyelitis caused by poliovirus Types 1, 2, and 3.²⁸

Infants, Children And Adolescents

General Recommendations

It is recommended that all infants (as young as 6 weeks of age), unimmunized children and adolescents not previously immunized be vaccinated routinely against paralytic poliomyelitis.²⁹ Following the eradication of poliomyelitis caused by wild poliovirus from the Western Hemisphere (including North and South America).³⁰ An IPV-only schedule was recommended to eliminate VAPP.⁷

All children should receive four doses of IPV at ages 2, 4, 6 to 18 months and 4 to 6 years. OPV is no longer available in the US and is not recommended for routine immunization.⁷ OPV is only recommended for special circumstances including the control of outbreaks.

Previous clinical poliomyelitis (usually due to only a single poliovirus type) or incomplete immunization with OPV are not contraindications to completing the primary series of immunization with IPOL vaccine.

Children Incompletely Immunized

Children of all ages should have their immunization status reviewed and be considered for supplemental immunization as follows for adults. Time intervals between doses longer than those recommended for routine primary immunization do not necessitate additional doses as long as a final total of four doses is reached (see DOSAGE AND ADMINISTRATION section).

Adults

General Recommendations

Routine primary poliovirus vaccination of adults (generally those 18 years of age or older) residing in the US is not recommended. Unimmunized adults who are potentially exposed to wild poliovirus and have not been adequately immunized should receive polio vaccination in accordance with the schedule given in the DOSAGE AND ADMINISTRATION section.²⁸

Persons with previous wild poliovirus disease who are incompletely immunized or unimmunized should be given additional doses of IPOL vaccine if they fall into one or more categories listed previously.

The following categories of adults are at an increased risk of exposure to wild polioviruses:^28,31

• Travelers to regions or countries where poliomyelitis is endemic or epidemic.
• Health-care workers in close contact with patients who may be excreting polioviruses.
• Laboratory workers handling specimens that may contain polioviruses.
• Members of communities or specific population groups with disease caused by wild polioviruses.

Immunodeficiency And Altered Immune Status

IPOL vaccine should be used in all patients with immunodeficiency diseases and members of such patients' households when vaccination of such persons is indicated. This includes patients with asymptomatic HIV infection, AIDS or AIDS-Related Complex, severe combined immunodeficiency, hypogammaglobulinemia, or agammaglobulinemia; altered immune states due to diseases such as leukemia, lymphoma, or generalized malignancy; or an immune system compromised by treatment with corticosteroids, alkylating drugs, antimetabolites or radiation. Immunogenicity of IPOL vaccine in individuals receiving immunoglobulin could be impaired and patients with an altered immune state may or may not develop a protective response against paralytic poliomyelitis after administration of IPV.³²

As with any vaccine, vaccination with IPOL vaccine may not protect 100% of individuals.

Use with other vaccines: refer to DOSAGE AND ADMINISTRATION section for this information.

Before administration, parenteral drug products should be checked visually for any deviation from normal appearance including container integrity. The syringe or vial and its packaging should be inspected prior to use for evidence of leakage, premature activation of the plunger, or a faulty tip seal. If evidence of such defects are observed, the syringe should not be used.

After preparation of the injection site, immediately administer IPOL vaccine intramuscularly or subcutaneously. In infants and small children, the mid-lateral aspect of the thigh is the preferred site. In older children and adults IPOL vaccine should be administered intramuscularly or subcutaneously in the deltoid area.

The syringe is intended for single use only, must not be reused, and must be disposed of properly and promptly following its use.

To help avoid HIV (AIDS), HBV (Hepatitis), and other infectious diseases due to accidental needlesticks, contaminated needles should not be recapped or removed, unless there is no alternative or that such action is required by a specific medical procedure.

Care should be taken to avoid administering the injection into or near blood vessels and nerves. If blood or any suspicious discoloration appears in the syringe, do not inject but discard contents and repeat procedures using a new dose of vaccine administered at a different site.

DO NOT ADMINISTER VACCINE INTRAVENOUSLY.

Children

The primary series of IPOL vaccine consists of three 0.5 mL doses administered intramuscularly or subcutaneously, preferably eight or more weeks apart and usually at ages 2, 4, and 6 to 18 months. Under no circumstances should the vaccine be given more frequently than four weeks apart. The first immunization may be administered as early as six weeks of age. For this series, a booster dose of IPOL vaccine is administered at 4 to 6 years of age.⁴¹

Use with Other Vaccines

From historical data on the antibody responses to diphtheria, tetanus, whole-cell or acellular pertussis, Hib, or hepatitis B vaccines used concomitantly with IPOL vaccine, no interferences have been observed on the immunological end points accepted for clinical protection.^11,16,36 (See DRUG INTERACTIONS section.)

If the third dose of IPOL vaccine is given between 12 to 18 months of age, it may be desirable to administer this dose with Measles, Mumps, and Rubella (MMR) vaccine and/or other vaccines using separate syringes at separate sites,²⁸ but no data on the immunological interference between IPOL vaccine and these vaccines exist.

Use in Previously Vaccinated Children

Children and adolescents with a previously incomplete series of polio vaccine should receive sufficient additional doses of IPOL vaccine to complete the series. OPV is no longer recommended for routine immunization and is recommended only in special circumstances7 (see General Recommendations section).

Interruption of the recommended schedule with a delay between doses does not interfere with the final immunity. There is no need to start the series over again, regardless of the time elapsed between doses.

The need to routinely administer additional doses is unknown at this time.²⁸

Adults

Unvaccinated Adults

A primary series of IPOL vaccine is recommended for unvaccinated adults at increased risk of exposure to poliovirus. While the responses of adults to primary series have not been studied, the recommended schedule for adults is two doses given at a 1 to 2 month interval and a third dose given 6 to 12 months later. If less than 3 months but more than 2 months are available before protection is needed, three doses of IPOL vaccine should be given at least 1 month apart. Likewise, if only 1 or 2 months are available, two doses of IPOL vaccine should be given at least 1 month apart. If less than 1 month is available, a single dose of IPOL vaccine is recommended.²⁸

Incompletely Vaccinated Adults

Adults who are at an increased risk of exposure to poliovirus and who have had at least one dose of OPV, fewer than three doses of conventional IPV or a combination of conventional IPV or OPV totaling fewer than three doses should receive at least one dose of IPOL vaccine. Additional doses needed to complete a primary series should be given if time permits.²⁸

Completely Vaccinated Adults

Adults who are at an increased risk of exposure to poliovirus and who have previously completed a primary series with one or a combination of polio vaccines can be given a dose of IPOL vaccine.

The preferred injection site of IPOL vaccine for adults is in the deltoid area.

Syringe, without needle, 0.5 mL (10 per package).

Product No. 49281-860-55

Vial, 10 Dose . Product No. 49281-860-10

CPT® Code: 90713

CPT is a registered trademark of the American Medical Association.

Storage

The vaccine is stable if stored in the refrigerator at 2°C to 8°C (35°F to 46°F). The vaccine must not be frozen.

REFERENCES

7. ACIP. Updated Recommendations of the Advisory Committee on Immunization Practices. Poliomyelitis Prevention in the United States. MMWR 49: No. RR-5, 2000

11. Unpublished data available from Sanofi Pasteur SA

16. Plotkin SA, et al. Inactivated polio vaccine for the United States: a missed vaccination opportunity. Pediatr Infect Dis J 14: 835839, 1995

28. ACIP. Poliomyelitis prevention in the United States: introduction of a sequential vaccination schedule of Inactivated Poliovirus Vaccine followed by Oral Poliovirus Vaccine. MMWR 46: No. RR-3, 1997

29. WHO. Weekly Epidemiology Record 54: 82-83, 1979

30. Certification of poliomyelitis eradication . the Americas, 1994. MMWR 43: 720-722, 1994

31. Institute of Medicine. An evaluation of poliomyelitis vaccine poliomyelitis vaccine policy options. Washington, DC. National Academy of Sciences, 1988

36. Vidor E, et al. Fifteen-years experience with vero-produced enhanced potency inactivated poliovirus vaccine (eIPV). Ped Infect Dis J, 312-322, 1997

41. Recommended childhood immunization schedule . United States, 1999. MMWR 48: 12-16, 1999

Manufactured by: Sanofi Pasteur SA, Lyon France. Distributed by: Sanofi Pasteur Inc., Swiftwater PA 18370 USA. 1-800-VACCINE (1-800-822-2463)

Last updated on RxList: 2/20/2009

Body System As A Whole

In earlier studies with the vaccine grown in primary monkey kidney cells, transient local reactions at the site of injection were observed.³Erythema, induration and pain occurred in 3.2%, 1% and 13%, respectively, of vaccinees within 48 hours post-vaccination. Temperatures of ≥ 39°C ( ≥ 102°F) were reported in 38% of vaccinees. Other symptoms included irritability, sleepiness, fussiness, and crying. Because IPV was given in a different site but concurrently with Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (DTP), these systemic reactions could not be attributed to a specific vaccine. However, these systemic reactions were comparable in frequency and severity to that reported for DTP given alone without IPV.¹² Although no causal relationship has been established, deaths have occurred in temporal association after vaccination of infants with IPV.³⁷

Four additional US studies using IPOL vaccine in more than 1,300 infants,¹² between 2 to 18 months of age administered with DTP at the same time at separate sites or combined have demonstrated that local and systemic reactions were similar when DTP was given alone.

TABLE 2¹²: PERCENTAGE OF INFANTS PRESENTING WITH LOCAL OR SYSTEMIC REACTIONS AT 6, 24, AND 48 HOURS OF IMMUNIZATION WITH IPOL VACCINE ADMINISTERED INTRAMUSCULARLY CONCOMITANTLY AT SEPARATE SITES WITH SANOFI^¶ WHOLE-CELL DTP VACCINE AT 2 AND 4 MONTHS OF AGE AND WITH SANOFI ACELLULAR PERTUSSIS VACCINE (TRIPEDIAR) AT 18 MONTHS OF AGE

Digestive System

Anorexia and vomiting occurred with frequencies not significantly different as reported when DTP was given alone without IPV or OPV.¹²

Nervous System

Although no causal relationship between IPOL vaccine and GBS has been established,²⁸ GBS has been temporally related to administration of another inactivated poliovirus vaccine.

Reporting of Adverse Events

The National Vaccine Injury Compensation Program, established by the National Childhood Vaccine Injury Act of 1986, requires physicians and other health-care providers who administer vaccines to maintain permanent vaccination records and to report occurrences of certain adverse events to the US Department of Health and Human Services. Reportable events include those listed in the Act for each vaccine and events specified in the package insert as contraindications to further doses of that vaccine.^38,39,40

Reporting by parents or guardians of all adverse events after vaccine administration should be encouraged. Adverse events following immunization with vaccine should be reported by health-care providers to the US Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS). Reporting forms and information about reporting requirements or completion of the form can be obtained from VAERS through a toll-free number 1-800-822-7967.^38,39,40

Health-care providers also should report these events to the Pharmacovigilance Department, Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 or call 1-800-822-2463.

There are no known interactions of IPOL vaccine with drugs or foods. Concomitant administration, of other parenteral vaccines, with separate syringes at separate sites, is not contraindicated. The first two doses of IPOL vaccine may be administered at separate sites using separate syringes concomitantly with DTaP, acellular pertussis, Haemophilus influenzae type b (Hib), and hepatitis B vaccines. From historical data on the antibody responses to diphtheria, tetanus, acellular pertussis, Hib, or hepatitis B vaccines used concomitantly or in combination with IPOL vaccine, no interferences have been observed on the immunological end points accepted for clinical protection.^11,16,36 (See DOSAGE AND ADMINISTRATION section.)

If IPOL vaccine has been administered to persons receiving immunosuppressive therapy, an adequate immunologic response may not be obtained. (See PRECAUTIONS - General section.)

REFERENCES

3. McBean AM, et al. Serologic response to oral polio vaccine and enhanced-potency inactivated polio vaccines. Am J Epidemiol 128: 615-628, 1988

11. Unpublished data available from Sanofi Pasteur SA

16. Plotkin SA, et al. Inactivated polio vaccine for the United States: a missed vaccination opportunity. Pediatr Infect Dis J 14: 835839, 1995

12. Unpublished data available from Sanofi Pasteur Inc.

28. ACIP. Poliomyelitis prevention in the United States: introduction of a sequential vaccination schedule of Inactivated Poliovirus Vaccine followed by Oral Poliovirus Vaccine. MMWR 46: No. RR-3, 1997

36. Vidor E, et al. Fifteen-years experience with vero-produced enhanced potency inactivated poliovirus vaccine (eIPV). Ped Infect Dis J, 312-322, 1997

37. Stratton, R. et al. Adverse Events Associated with Childhood Vaccines. Polio Vaccines. National Academy Press, 295-299, 1994

38. CDC. Vaccine Adverse Event Reporting System . United States. MMWR 39: 730-733, 1990

39. CDC. National Childhood Vaccine Injury Act. Requirements for permanent vaccination records and for reporting of selected events after vaccination. MMWR 37: 197-200, 1988

40. Food & Drug Administration. New Reporting Requirements for Vaccine Adverse Events. FDA Drug Bull 18 (2), 16-18, 1988

Last updated on RxList: 2/20/2009

Neomycin, streptomycin, polymyxin B, 2-phenoxyethanol, and formaldehyde are used in the production of this vaccine. Although purification procedures eliminate measurable amounts of these substances, traces may be present (see DESCRIPTION section) and allergic reactions may occur in persons sensitive to these substances (see CONTRAINDICATIONS section).

Systemic adverse reactions reported in infants receiving IPV concomitantly at separate sites or combined with DTP have been similar to those associated with administration of DTP alone.¹¹ Local reactions are usually mild and transient in nature.

Although no causal relationship between IPOL vaccine and Guillain-Barre Syndrome (GBS) has been established,²⁸ GBS has been temporally related to administration of another inactivated poliovirus vaccine. Deaths have been reported in temporal association with the administration of IPV (see ADVERSE REACTIONS section).

General

Prior to an injection of any vaccine, all known precautions should be taken to prevent adverse reactions. This includes a review of the patient's history with respect to possible sensitivity to the vaccine or similar vaccines.

Health-care providers should question the patient, parent or guardian about reactions to a previous dose of this product, or similar product.

Epinephrine Injection (1:1000) and other appropriate agents should be available to control immediate allergic reactions.

Health-care providers should obtain the previous immunization history of the vaccinee, and inquire about the current health status of the vaccinee.

Immunodeficient patients or patients under immunosuppressive therapy may not develop a protective immune response against paralytic poliomyelitis after administration of IPV.

Administration of IPOL vaccine is not contraindicated in individuals infected with HIV.^33,34,35

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

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long-term studies in animals to evaluate carcinogenic potential or impairment of fertility have not been conducted.

Pregnancy Category C

Animal reproduction studies have not been conducted with IPOL vaccine. It is also not known whether IPOL vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. IPOL vaccine should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether IPOL vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when IPOL vaccine is administered to a nursing woman.

Pediatric Use

SAFETY AND EFFECTIVENESS OF IPOL VACCINE IN INFANTS BELOW SIX WEEKS OF AGE HAVE NOT BEEN ESTABLISHED. ^12,20 (See DOSAGE AND ADMINISTRATION section.)

In the US, infants receiving two doses of IPV at 2 and 4 months of age, the seroprevalence to all three types of poliovirus was demonstrated in 95% to 100% of these infants after two doses of vaccine.^12,13

REFERENCES

11. Unpublished data available from Sanofi Pasteur SA

12. Unpublished data available from Sanofi Pasteur Inc.

13. Faden H, et al. Comparative evaluation of immunization with live attenuated and enhanced potency inactivated trivalent poliovirus vaccines in childhood: Systemic and local immune responses. J Infect Dis 162: 1291-1297, 1990

16. Plotkin SA, et al. Inactivated polio vaccine for the United States: a missed vaccination opportunity. Pediatr Infect Dis J 14: 835839, 1995

28. ACIP. Poliomyelitis prevention in the United States: introduction of a sequential vaccination schedule of Inactivated Poliovirus Vaccine followed by Oral Poliovirus Vaccine. MMWR 46: No. RR-3, 1997

33. ACIP. General recommendations on immunization. MMWR 43: No. RR-1, 1994

34. Barbi M, et al. Antibody response to inactivated polio vaccine (eIPV) in children born to HIV positive mothers. Eur J Epidemiol 8: 211-216, 1992

35. Varon D, et al. Response to hemophilic patients to poliovirus vaccination: Correlation with HIV serology and with immunological parameters. J Med Virol 40: 91-95, 1993

36. Vidor E, et al. Fifteen-years experience with vero-produced enhanced potency inactivated poliovirus vaccine (eIPV). Ped Infect Dis J, 312-322, 1997

Last updated on RxList: 2/20/2009

No information provided.

IPOL vaccine is contraindicated in persons with a history of hypersensitivity to any component of the vaccine, including 2-phenoxyethanol, formaldehyde, neomycin, streptomycin and polymyxin B.

No further doses should be given if anaphylaxis or anaphylactic shock occurs within 24 hours of administration of one dose of vaccine.

Vaccination of persons with an acute, febrile illness should be deferred until after recovery; however, minor illness, such as mild upper respiratory infection, with or without low grade fever, are not reasons for postponing vaccine administration.

Last updated on RxList: 2/20/2009

Poliomyelitis is caused by poliovirus Types 1, 2, or 3. It is primarily spread by the fecal-oral route of transmission but may also be spread by the pharyngeal route.

Approximately 90% to 95% of poliovirus infections are asymptomatic. Nonspecific illness with low-grade fever and sore throat (minor illness) occurs in 4% to 8% of infections. Aseptic meningitis occurs in 1% to 5% of patients a few days after the minor illness has resolved. Rapid onset of asymmetric acute flaccid paralysis occurs in 0.1% to 2% of infections, and residual paralytic disease involving motor neurons (paralytic poliomyelitis) occurs in approximately 1 per 1,000 infections.⁵

Prior to the introduction of inactivated poliovirus vaccines in 1955, large outbreaks of poliomyelitis occurred each year in the United States (US). The annual incidence of paralytic disease of 11.4 cases/100,000 population declined to 0.5 cases by the time oral poliovirus vaccine (OPV) was introduced in 1961. Incidence continued to decline thereafter to a rate of 0.002 to 0.005 cases per 100,000 population. Of the 127 cases of paralytic poliomyelitis reported in the US between 1980 and 1994, six were imported cases (caused by wild polioviruses), two were “ indeterminate” cases, and 119 were vaccine associated paralytic poliomyelitis (VAPP) cases associated with the use of live, attenuated oral poliovirus vaccine (OPV).⁶ An all IPVschedule was adopted in 1999, to eliminate VAPP cases.⁷

Poliovirus Vaccine Inactivated induces the production of neutralizing antibodies against each type of virus which are related to protective efficacy. Antibody response in most children were induced after receiving fewer doses⁸ of IPV vaccine than the vaccine available in the United States prior to 1988.

Studies in developed⁸ and developing^9,10 countries with a similar enhanced IPV manufactured by the same process as IPOL vaccine in primary monkey kidney cells have shown a direct relationship exists between the antigenic content of the vaccine, the frequency of seroconversion, and resulting antibody titer. Approval in the US was based upon demonstration of immunogenicity and safety in US children.¹¹

In the US, 219 infants received three doses of a similar enhanced IPV at two, four and eighteen months of age manufactured by the same process as IPOL vaccine except the cell substrate for IPV was using primary monkey kidney cells. Seroconversion to all three types of poliovirus was demonstrated in 99% of these infants after two doses of vaccine given at 2 and 4 months of age. Following the third dose of vaccine at 18 months of age, neutralizing antibodies were present at a level of ≥ 1:10 in 99.1% of children to Type 1 and 100% of children to Types 2 and 3 polioviruses.³

IPOL vaccine was administered to more than 700 infants between 2 to 18 months of age during three clinical studies conducted in the US using IPV only schedules and sequential IPV-OPV schedules.^12,13 Seroprevalence rates for detectable serum neutralizing antibody (DA) at a ≥ 1:4 dilution were 95% to 100% (Type 1); 97% to 100% (Type 2) and 96% to 100% (Type 3) after two doses of IPOL vaccine depending on studies.

TABLE 1: US STUDIES WITH IPOL VACCINE ADMINISTERED USING IPV ONLY OR SEQUENTIAL IPV-OPV SCHEDULES

In one study,¹³ the persistence of DA in infants receiving two doses of IPOL vaccine at 2 and 4 months of age was 91% to 100% (Type 1), 97% to 100% (Type 2), and 93% to 94% (Type 3) at twelve months of age. In another study,¹² 86% to 100% (Type 1), 95% to 100% (Type 2), and 82% to 94% (Type 3) of infants still had DA at 18 months of age.

In trials and field studies conducted outside the US, IPOL vaccine, or a combination vaccine containing IPOL vaccine and DTP, was administered to more than 3,000 infants between 2 to 18 months of age using IPV only schedules and immunogenicity data are available from 1,485 infants. After two doses of vaccine given during the first year of life, seroprevalence rates for detectable serum neutralizing antibody (neutralizing titer ≥ 1:4) were 88% to 100% (Type 1); 84% to100% (Type 2) and 94% to 100% (Type 3) of infants, depending on studies. When three doses were given during the first yearof life, post-dose 3 DA ranged between 93% to 100% (Type 1); 89% to 100% (Type 2) and 97% to 100% (Type 3) and reached 100% for Types 1, 2, and 3 after the fourth dose given during the second year of life (12 to 18 months of age).¹⁴

In infants immunized with three doses of an unlicensed combination vaccine containing IPOL vaccine and DTP given during the first year of life, and a fourth dose given during the second year of life, the persistence of detectable neutralizing antibodies was 96%, 96% and 97% against poliovirus Types 1, 2, and 3, respectively, at six years of age. DA reached 100% for all types after a booster dose of IPOL vaccine combined with DTP vaccine.11 A survey of Swedish children and young adults given a Swedish IPV only schedule demonstrated persistence of detectable serum neutralizing antibody for at least 10 years to all three types of poliovirus.¹⁵

IPV is able to induce secretory antibody (IgA) produced in the pharynx and gut and reduces pharyngeal excretion of poliovirus Type 1 from 75% in children with neutralizing antibodies at levels less than 1:8 to 25% in children with neutralizing antibodies at levels more than 1:64.^4,14,16-22 There is also evidence of induction of herd immunity with IPV,^15,23-26 and that this herd immunity is sufficiently maintained in a population vaccinated only with IPV.²⁶

VAPP has not been reported in association with administration of IPOL vaccine.²⁷ It is expected that an IPV only schedule will eliminate the risk of VAPP in both recipients and contacts compared to a schedule that included OPV.⁷

REFERENCES

5. Sabin AB. Poliomyelitis. In Brande AI, Davis CE, Fierer J (eds) International Textbook of Medicine, Vol II. Infectious Diseases and Medical Microbiology. 2nd ed. Philadelphia, WBSaunders, 1986

6. Prevots DR, et al. Vaccine-associated paralytic poliomyelitis in the United States, l980-1994: current risk and potential impact of a proposed sequential schedule of IPV followed by OPV (Abstract #H90). In: Abstracts of the 36th Interscience Conference on Antimicrobial Agents and Chemotherapy. Washington, DC. American Society for Microbiology, 179, 1996

7. ACIP. Updated Recommendations of the Advisory Committee on Immunization Practices. Poliomyelitis Prevention in the United States. MMWR 49: No. RR-5, 2000

8. Salk J, et al. Antigen content of inactivated poliovirus vaccine for use in a one- or two-dose regimen. Ann Clin Res 14: 204-212, 1982

9. Salk J, et al. Killed poliovirus antigen titration in humans. Develop Biol Standard 41: 119-132, 1978

10. Salk J, et al. Theoretical and practical considerations in the application of killed poliovirus vaccine for the control of paralytic poliomyelitis. Develop Biol Standard 47: 181-198, 1981

11. Unpublished data available from Sanofi Pasteur SA

12. Unpublished data available from Sanofi Pasteur Inc.

13. Faden H, et al. Comparative evaluation of immunization with live attenuated and enhanced potency inactivated trivalent poliovirus vaccines in childhood: Systemic and local immune responses. J Infect Dis 162: 1291-1297, 1990

14. Vidor E, et al. The place of DTP/eIPV vaccine in routine pædiatric vaccination. Rev Med Virol 4: 261-277, 1994

15. Bottiger M. Long-term immunity following vaccination with killed poliovirus vaccine in Sweden, a country with no circulating poliovirus. Rev Infect Dis 6 (Suppl 2): S548-S551, 1984

16. Plotkin SA, et al. Inactivated polio vaccine for the United States: a missed vaccination opportunity. Pediatr Infect Dis J 14: 835839, 1995

17. Marine WM, et al. Limitation of fecal and pharyngeal poliovirus excretion in Salk-vaccinated children. A family study during a Type 1 poliomyelitis epidemic. Amer J Hyg 76: 173-195, 1962

18. Bottiger M, et al. Vaccination with attenuated Type 1 poliovirus, the Chat strain. II. Transmission of virus in relation to age. Acta Paed Scand 55: 416-421, 1966

19. Dick GWA, et al. Vaccination against poliomyelitis with live virus vaccines. Effect of previous Salk vaccination on virus excretion. Brit Med J 2: 266-269, 1961

20. Wehrle PF, et al. Transmission of poliovirus; III. Prevalence of polioviruses in pharyngeal secretions of infected household contacts of patients with clinical disease. Pediatrics 27: 762-764, 1961

21. Adenyi-Jones SC, et al. Systemic and local immune responses to enhanced-potency inactivated poliovirus vaccine in premature and term infants. J Pediatr 120: No 5, 686-689, 1992

22. Chin TDY. Immunity induced by inactivated poliovirus vaccine and excretion of virus. Rev Infect Dis 6 (Suppl 2): S369-S370, 1984

23. Salk D. Herd effect and virus eradication with use of killed poliovirus vaccine. Develop Biol Standard 47: 247-255, 1981

24. Bijerk H. Surveillance and control of poliomyelitis in the Netherlands. Rev Infect Dis 6 (Suppl 2): S451-S456, 1984

25. Lapinleimu K. Elimination of poliomyelitis in Finland. Rev Infect Dis 6 (Suppl 2): S457-S460, 1984

26. Conyn van Spaendonck M, et al. Circulation of Poliovirus during the poliomyelitis outbreak in the Netherlands in 1992-1993. Amer J Epidemiology 143: 929-935, 1996

27. Strebel PM, et al. Epidemiology of poliomyelitis in the United States one decade after the last reported case of indigenous wild virus associated disease. Clin Infect Dis 14: 568-579, 1992

Last updated on RxList: 2/20/2009

Patients, parents, or guardians should be instructed to report any serious adverse reactions to their health-care provider.

The health-care provider should inform the patient, parent, or guardian of the benefits and risks of the vaccine.

The health-care provider should inform the patient, parent, or guardian of the importance of completing the immunization series.

The health-care provider should provide the Vaccine Information Statements (VISs) which are required to be given with each immunization.

Last updated on RxList: 2/20/2009

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

POLIOVIRUS VACCINE - INJECTION

(POE-lee-oh)

COMMON BRAND NAME(S): Ipol

USES: This medication is a vaccine used to prevent polio virus infection in infants and children. It may also be given to adults at high risk for polio infection (e.g., before travel to countries where polio is common, in some health care settings). Polio infection may be mild or severe. Severe infections may damage nerve cells, causing an inability to move (paralysis) in part of the body (e.g., legs, arms, breathing muscles). This vaccine works by increasing the body's natural defense (immunity) against the virus.

This injected vaccine is made from inactive/killed virus and does not cause polio.

HOW TO USE: Read the Vaccine Information Leaflet available from your health care provider before receiving each dose of this vaccine. If you have any questions, consult your doctor or pharmacist.

This medication is injected under the skin or into a muscle of the thigh/upper arm by a health care professional. This medication must not be injected directly into a vein. This product should be clear and colorless. Before injecting the liquid, check it visually for particles and discoloration. If either is present, do not use the liquid.

Children receive the vaccine in 4 separate doses. The recommended vaccination schedule is a dose at 2 months, 4 months, 6 to 18 months, 4 to 6 years. Adults receive 1 to 3 doses depending upon their previous vaccination history and medical condition. All doses are given at least 4 weeks apart. The vaccination schedule should be followed closely for the best protection. To help you remember to receive the vaccine on time, mark your calendar with a reminder.

This vaccine may be safely given at the same time as other vaccines, using separate syringes and injection sites. Do not mix polio vaccine with other vaccines in the same syringe.

SIDE EFFECTS: Redness/swelling/tenderness at the injection site, fever, irritability, and tiredness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: fast/slow/irregular heartbeat, weakness.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using poliovirus vaccine, tell your doctor or pharmacist if you are allergic to it; or to neomycin, streptomycin, polymyxin B, 2-phenoxyethanol, or formaldehyde; or if you have any other allergies.

Before receiving this vaccination, tell your doctor or pharmacist your medical history, especially of: current fever/illness, blood/organ transplant, immune system problems (e.g., HIV infection), severe reaction to any other vaccination.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this vaccine passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medication because very serious interactions may occur: efalizumab.

If you are currently using the drug listed above, tell your doctor, pharmacist, or other health care provider before receiving poliovirus vaccine.

Before receiving this vaccination, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially: cancer chemotherapy, corticosteroids (e.g., prednisone, dexamethasone), drugs that weaken the immune system (e.g., azathioprine, cyclosporine, methotrexate, tacrolimus).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: Overdose with this vaccine is highly unlikely. If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: As with all vaccines, this vaccine may not fully protect everyone who receives it. Incomplete protection is more likely if you have an immune system problem or are taking medications that affect your immune system. See Precautions and Drug Interactions sections. If needed, your doctor can check your blood to see how well you are protected from polio infection. Contact your doctor for details.

MISSED DOSE: It is important to receive each vaccination as scheduled and to complete the vaccination series. Be sure to make a note of when each vaccination was given for your medical record.

STORAGE: Refrigerate between 35-46 degrees F (2-8 degrees C). Do not freeze. Discard the product if it has been frozen. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.