Vaccine Information: IPOL (Page 3 of 4)

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.

Post-marketing Experience

The following adverse events have been identified during postapproval use of IPOL vaccine. Because these events are reported voluntarily from a population of uncertain size, it may not be possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Adverse events were included based on one or more of the following factors: severity, frequency of reporting or strength of evidence for a causal relationship.

  • Blood and lymphatic system disorders: lymphadenopathy
  • General disorders and administration site conditions: agitation, injection site reaction including injection site rash and mass
  • Immune system disorders: type I hypersensitivity including allergic reaction, anaphylactic reaction, and anaphylactic shock
  • Musculoskeletal and connective tissue disorders: arthralgia, myalgia
  • Nervous system disorders: convulsion, febrile convulsion, headache, paresthesia, and somnolence
  • Skin and subcutaneous tissue disorders: rash, urticaria

Reporting of Adverse Events

The National Vaccine Injury Compensation Program, established by the National Childhood Vaccine Injury Act of 1986, requires physicians and other healthcare 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 healthcare 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)

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

DOSAGE AND ADMINISTRATION

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The vial and its packaging should be inspected prior to use for evidence of leakage or a faulty seal. If evidence of such defects are observed, the vaccine should not be used. Do not remove the vial stopper or the metal seal holding it in place.

After preparation of the injection site, using a suitable sterile needle and aseptic technique, 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. IPOL should not be combined through reconstitution or mixed with any other vaccine.

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.

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 0.5 mL doses given at a 1 to 2 month interval and a third 0.5 mL 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 0.5 mL doses of IPOL vaccine should be given at least 1 month apart. If less than 1 month is available, a single 0.5 mL 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 0.5 mL 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 0.5 mL dose of IPOL vaccine.

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

HOW SUPPLIED

Product: 50090-1693

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.
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, WB Saunders, 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 p├Ždiatric 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: 835-839, 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.
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.
32
ACIP. Immunization of children infected with human T-lymphotropic virus type III/lymphadenopathy-associated virus. MMWR 35: 595-606, 1986.
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.
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.
41
Recommended childhood immunization schedule — United States, 1999. MMWR 48: 12-16, 1999.

Product Information as of August 2015

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Sanofi Pasteur SA
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Swiftwater PA 18370 USA
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