Vaccine Information: IPOL (Page 2 of 4)

IPOL Indications and Usage

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)

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.

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.
  • Healthcare 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.

CONTRAINDICATIONS

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.

WARNINGS

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-Barré 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).

PRECAUTIONS

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.

Healthcare 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.

Healthcare 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.

INFORMATION FOR PATIENTS

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

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

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

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

DRUG INTERACTIONS

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.)

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

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

PREGNANCY

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)

ADVERSE REACTIONS

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. (3) Erythema, 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 2 (12): 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 (Tripedia®) at 18 Months of Age
AGE AT IMMUNIZATION
REACTION 2 Months
(n=211)
4 Months
(n=206)
18 Months
(n=74)
6 Hrs. 24 Hrs. 48 Hrs. 6 Hrs. 24 Hrs. 48 Hrs. 6 Hrs. 24 Hrs. 48 Hrs.
*
Sanofi Pasteur Inc. formerly known as Aventis Pasteur Inc.
Children who have been vaccinated with Tripedia vaccine.
Data are from the IPOL vaccine administration site, given intramuscularly.
§
The adverse reaction profile includes the concomitant use of Sanofi whole-cell DTP vaccine or Tripedia vaccine with IPOL vaccine. Rates are comparable in frequency and severity to that reported for whole-cell DTP given alone.
Local, IPOL vaccine alone
Erythema >1″ 0.5% 0.5% 0.5% 1.0% 0.0% 0.0% 1.4% 0.0% 0.0%
Swelling 11.4% 5.7% 0.9% 11.2% 4.9% 1.9% 2.7% 0.0% 0.0%
Tenderness 29.4% 8.5% 2.8% 22.8% 4.4% 1.0% 13.5% 4.1% 0.0%
Systemic §
Fever >102.2°F 1.0% 0.5% 0.5% 2.0% 0.5% 0.0% 0.0% 0.0% 4.2%
Irritability 64.5% 24.6% 17.5% 49.5% 25.7% 11.7% 14.7% 6.7% 8.0%
Tiredness 60.7% 31.8% 7.1% 38.8% 18.4% 6.3% 9.3% 5.3% 4.0%
Anorexia 16.6% 8.1% 4.3% 6.3% 4.4% 2.4% 2.7% 1.3% 2.7%
Vomiting 1.9% 2.8% 2.8% 1.9% 1.5% 1.0% 1.3% 1.3% 0.0%
Persistent Crying Percentage of infants within 72 hours after immunization was 0.0% after dose one, 1.4% after dose two, and 0.0% after dose three.

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.