Adacel/Adacel Polio

Adacel: ADACEL appears as a cloudy white suspension.
1 dose (0.5 mL) contains: Tetanus Toxoid 5 Lf. Diphtheria Toxoid 2 Lf. Acellular Pertussis: Pertussis Toxoid (PT) 2.5 μg, Filamentous Haemagglutinin (FHA) 5 μg, Pertactin (PRN) 3 μg, Fimbriae Types 2 and 3 (FIM) 5 μg.
Excipients/Inactive Ingredients: Aluminum Phosphate (adjuvant), 2-phenoxyethanol.
This vaccine may contain traces of formaldehyde and glutaraldehyde which are used during the manufacturing process (see Contraindications and Precautions).
Adacel Polio: ADACEL-POLIO (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine) is a sterile, uniform, cloudy, white suspension of tetanus and diphtheria toxoids and acellular pertussis vaccine adsorbed separately on aluminum phosphate, combined with inactivated poliomyelitis vaccine (vero cell origin) types 1, 2 and 3, and suspended in water for injection. The acellular pertussis vaccine is composed of five purified pertussis antigens (PT, FHA, PRN and FIM).
Each dose (0.5 mL) is formulated to contain: Tetanus Toxoid Not less than 20 International Units (5 Lf). Diphtheria Toxoid Not less than 2 International Units (2 Lf).
Acellular Pertussis: Pertussis Toxoid (PT) 2.5 μg, Filamentous Haemagglutinin (FHA) 5 μg, Pertactin (PRN) 3 μg, Fimbriae Types 2 and 3 (FIM) 5 μg. Inactivated Poliomyelitis Vaccine, Type 1 (Mahoney) 40 D-antigen units*, Type 2 (MEF-1) 8 D-antigen units*, Type 3 (Saukett) 32 D-antigen units*.
*or the equivalent antigen quantity, determined by suitable immunochemical method.
Excipients/Inactive Ingredients: Aluminum Phosphate (adjuvant) 1.5 mg, 2-phenoxyethanol 0.6% v/v, Polysorbate 80 <5 μg, Water for Injection q.s. 0.5 mL.
Manufacturing Process Residuals: Bovine serum albumin, formaldehyde, glutaraldehyde, streptomycin, neomycin and polymyxin B are present in trace amounts.

Adacel: Pharmacotherapeutic group: Pertussis, purified antigen, combination with toxoids. ATC code: J07AJ52.
Pharmacology: Pharmacodynamics: Clinical trials: The immune responses observed one month after vaccination with ADACEL in 265 children, 527 adolescents and 743 adults are shown in the table as follows. (See Table 1.)

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The safety and immunogenicity of ADACEL in adults and adolescents was shown to be comparable to that observed with a single dose of an adult formulation diphtheria-tetanus (Td) adsorbed vaccine containing the same amount of tetanus and diphtheria toxoids.
Serological correlates for protection against pertussis have not been established. On comparison with data from the Sweden I pertussis efficacy trials conducted between 1992 and 1996, where primary immunization with Sanofi Pasteur acellular pertussis infant DTaP formulation confirmed a protective efficacy of 85% against pertussis disease, it is considered that ADACEL had elicited protective immune responses. The pertussis antibody levels for all antigens following a booster dose of ADACEL in adolescents and adults exceeded those observed in a household contact study nested within the efficacy trial. (See Table 2.)

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Antibody persistence: Serology follow-up studies were conducted at 3, 5 and 10 years, in individuals previously immunized with a single booster dose of ADACEL. Persistence of seroprotection to diphtheria and tetanus, and seropositivity to pertussis is summarised in Table 3. (See Table 3.)

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Immunogenicity following repeat vaccination: The immunogenicity of ADACEL following repeat vaccination 10 years after a previous dose of ADACEL or ADACEL-POLIO, has been evaluated. One month post-vaccination ≥98.5% of study participants achieved seroprotective antibody levels (≥0.1 IU/ml) for diphtheria and tetanus, and ≥84% achieved booster responses to the pertussis antigens. (A pertussis booster response was defined as a post-vaccination antibody concentration ≥4 times the LLOQ if the pre-vaccination level was < LLOQ; ≥4 times the pre-vaccination level if that was ≥ LLOQ but <4 times LLOQ; or ≥2 times the pre-vaccination level if that was ≥4 times the LLOQ).
Based on the serology follow-up and repeat vaccination data, ADACEL can be used instead of a dT vaccine to boost immunity to pertussis in addition to diphtheria and tetanus.
Immunogenicity in pregnant women: Pertussis antibody responses in pregnant women are generally similar to those in non-pregnant women. Vaccination during the second or third trimester of pregnancy is optimal for antibody transfer to the developing fetus.
Immunogenicity against pertussis in infants (<3 months of age) born to women vaccinated during pregnancy: Data from 2 published randomized controlled trials demonstrate higher pertussis antibody concentrations at birth and at 2 months of age, (ie, prior to the start of their primary vaccinations) in infants of women vaccinated with ADACEL during pregnancy compared with infants of women not vaccinated against pertussis during pregnancy.
In the first study, 33 pregnant women received ADACEL and 15 received saline placebo at 30 to 32 weeks gestation. The geometric mean concentrations (GMC) in EU/mL for the anti-pertussis antibodies to the PT, FHA, PRN, and FIM antigens in infants of vaccinated women were, respectively, 68.8, 234.2, 226.8, and 1867.0 at birth, and 20.6, 99.1, 75.7, and 510.4 at 2 months of age. In the control-group infants, the corresponding GMCs were 14.0, 25.1, 14.4, and 48.5 at birth, and 5.3, 6.6, 5.2, and 12.0 at 2 months. The GMC ratios (ADACEL/control group) were 4.9, 9.3, 15.8, and 38.5 at birth, and 3.9, 15.0, 14.6, and 42.5 at 2 months.
In the second study, 134 pregnant women received ADACEL and 138 received a tetanus and diphtheria control vaccine at a mean gestational age of 34.5 weeks. The GMCs (EU/mL) for the anti-pertussis antibodies to the PT, FHA, PRN, and FIM antigens in infants of vaccinated women were, respectively, 54.2, 184.2, 294.1, and 939.6 at birth, and 14.1, 51.0, 76.8, and 220.0 at 2 months of age. In the control-group infants, the corresponding GMCs were 9.5, 21.4, 11.2, and 31.5 at birth, and 3.6, 6.1, 4.4, and 9.0 at 2 months. The GMC ratios (ADACEL/control group) were 5.7, 8.6, 26.3, and 29.8 at birth, and 3.9, 8.4, 17.5, and 24.4 at 2 months.
These higher antibody concentrations should provide passive immunity against pertussis for the infant during the first 2 to 3 months of life, as has been shown by observational effectiveness studies.
Immunogenicity in infants and toddlers born to women vaccinated during pregnancy: For infants of women vaccinated with ADACEL or ADACEL-POLIO during pregnancy, the immunogenicity of routine infant vaccination was assessed in several published studies. Data on the infant response to pertussis and non-pertussis antigens were evaluated during the first year of life.
Maternal antibodies derived after ADACEL or ADACEL-POLIO vaccination in pregnancy may be associated with blunting of the infant immune response to active immunization against pertussis. Based on current epidemiological studies, this blunting may not have clinical relevance.
Data from several studies did not show any clinically relevant blunting from vaccination in pregnancy with ADACEL or ADACEL-POLIO and the infants' or toddlers' responses to diphtheria, tetanus, Haemophilus influenzae type b, inactivated poliovirus, or pneumococcal antigens.
Effectiveness against pertussis in infants born to women vaccinated during pregnancy: The vaccine effectiveness in the first 2-3 months of life for infants born to women vaccinated against pertussis during the third trimester of pregnancy has been evaluated in 3 observational studies. The overall effectiveness is >90%. (See Table 4.)

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Pharmacokinetics: Evaluation of pharmacokinetic properties is not required for vaccines.
Toxicology: Preclinical safety data: Non-clinical data revealed no special hazard for humans based on conventional studies of repeated dose toxicity and toxicity in pregnancy, embryonal/foetal development, parturition and postnatal development.

Adacel: ADACEL (Tdap) is indicated for: Active immunization against tetanus, diphtheria and pertussis in persons from 4 years of age as a booster following primary immunization.
Passive protection against pertussis in early infancy following maternal immunization during pregnancy (see Dosage & Administration, Use in Pregnancy & Lactation, and Pharmacology: Pharmacodynamics under Actions).
ADACEL should be used in accordance with official recommendations.
Adacel Polio: ADACEL-POLIO is indicated for active booster immunization for the prevention of tetanus, diphtheria, pertussis (whooping cough) and poliomyelitis in persons 4 years of age and above.
In children 4 to 6 years of age, ADACEL-POLIO may be considered as an alternative for the fifth dose of diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis vaccine (DTaP-IPV).
Persons who have had tetanus, diphtheria or pertussis should still be immunized since these clinical infections do not always confer immunity. Human Immunodeficiency Virus (HIV)-infected persons, both asymptomatic and symptomatic, should be immunized against tetanus, diphtheria and pertussis according to standard schedules.
ADACEL-POLIO is not to be used for the treatment of disease caused by Bordetella pertussis, Corynebacterium diphtheriae, Clostridium tetani or poliomyelitis infections.
Pediatrics: ADACEL-POLIO has been used in clinical studies in children as young as 3 years of age.
Geriatrics: ADACEL-POLIO has been used in clinical studies in persons up to 91 years of age.
Tetanus Prophylaxis in Wound Management: The need for active immunization with a tetanus toxoid-containing preparation (such as Td Adsorbed vaccine, ADACEL or ADACEL-POLIO) with or without passive immunization with Tetanus Immune Globulin, depends on both the condition of the wound and the patient's vaccination history (see Dosage & Administration).

Adacel: Posology: A single injection of one (0.5 mL) dose is recommended in all indicated age groups.
ADACEL can be used for repeat vaccination to boost immunity to diphtheria, tetanus and pertussis at 5 to 10 year intervals (see Pharmacology: Pharmacodynamics under Actions).
ADACEL can be used in the management of tetanus prone injuries with or without concomitant administration of Tetanus Immunoglobulin according to official recommendations.
ADACEL may be administered to pregnant women during the second or third trimester to provide passive protection of infants against pertussis (see Indications/Uses, Use in Pregnancy & Lactation, and Pharmacology: Pharmacodynamics under Actions).
Method of administration: A single injection of one dose (0.5 mL) of ADACEL should be administered intramuscularly. The preferred site is into the deltoid muscle.
ADACEL should not be administered into the gluteal area; intradermal or subcutaneous routes should not be used (in exceptional cases the subcutaneous route may be considered, see Precautions).
Precautions to be taken before handling or administering the medicinal product: For instructions on handling of the medicinal product before administration, see Special precautions for disposal under Cautions for Usage.
Adacel Polio: Recommended Dose: ADACEL-POLIO should be administered as a single injection of 1 dose (0.5 mL) by the intramuscular route. The preferred site is the deltoid muscle.
Fractional doses (doses <0.5 mL) should not be given. The effect of fractional doses on safety and efficacy has not been determined.
Health-care professionals should refer to the National Advisory Committee on Immunization (NACI) guidelines for tetanus prophylaxis in routine wound management shown in Table 5. (See Table 5.)

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A thorough attempt must be made to determine whether a patient has completed primary immunization. Persons who have completed primary immunization against tetanus and who sustain wounds that are minor and uncontaminated, should receive a booster dose of a tetanus toxoid-containing preparation if they have not received tetanus toxoid within the preceding 10 years. For tetanus-prone wounds (e.g., wounds contaminated with dirt, feces, soil and saliva, puncture wounds, avulsions and wounds resulting from missiles, crushing, burns or frostbite), a booster is appropriate if the patient has not received a tetanus toxoid-containing preparation within the preceding 5 years.
For adults who have not previously received a dose of acellular pertussis vaccine, a single Tetanus-diphtheria (Td) booster dose should be replaced by a combined tetanus-diphtheria-acellular pertussis vaccine (Tdap).
Administration: Inspect for extraneous particulate matter and/or discolouration before use (see Description). If these conditions exist, the product should be discarded.
Shake the vial or syringe well until a uniform, cloudy, suspension results. When administering a dose from a stoppered vial, do not remove either the stopper or the metal seal holding it in place. Use a separate sterile needle and syringe, or a sterile disposable unit for each individual patient to prevent disease transmission. Needles should not be recapped but should be disposed of according to biohazard waste guidelines.
Before injection, the skin over the site to be injected should be cleansed with a suitable germicide. Administer the total volume of 0.5 mL intramuscularly (IM). The preferred site of injection is the deltoid muscle.

Adacel: Not applicable.

Adacel: ADACEL should not be administered to person with known hypersensitivity: to diphtheria, tetanus or pertussis vaccines; to any other component of the vaccine (see Description); to any residual substances carried over from manufacture (formaldehyde and glutaraldehyde), which may be present in undetectable trace amounts.
ADACEL should not be administered to persons who experienced an encephalopathy of unknown origin within 7 days of previous immunization with a pertussis-containing vaccine.
As with other vaccines, administration of ADACEL should be postponed in persons suffering from an acute severe febrile illness. The presence of a minor infection is not a contraindication.
Adacel Polio: Hypersensitivity: Known systemic hypersensitivity reaction to any component of ADACEL-POLIO or a life-threatening reaction after previous administration of the vaccine or a vaccine containing one or more of the same components are contraindications to vaccination. Because of uncertainty as to which component of the vaccine may be responsible, none of the components should be administered. Alternatively, such persons may be referred to an allergist for evaluation if further immunizations are considered.
Acute Neurological Disorders: Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis-containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis-containing vaccine, including ADACEL-POLIO.

Adacel: ADACEL should not be used for primary immunization.
Regarding the interval between a booster dose of ADACEL and preceding booster doses of diphtheria and/or tetanus containing vaccines, the official recommendations should generally be followed.
Clinical data have demonstrated that there was no clinically relevant difference in rates of adverse reactions associated with administration of a tetanus-, diphtheria- and pertussis-containing booster vaccine as early as 4 weeks, compared to at least 5 years, after a preceding dose of tetanus and diphtheria-containing vaccine.
Prior to immunization: Vaccination should be preceded by a review of the person's medical history (in particular previous vaccinations and possible adverse events). In persons who have a history of serious or severe reaction within 48 hours of a previous injection with a vaccine containing similar components, administration of ADACEL vaccine must be carefully considered.
As with all injectable vaccines, appropriate medical treatment and supervision should be readily available for immediate use in case of a rare anaphylactic reaction following the administration of the vaccine.
If Guillain-Barré syndrome occurred within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give any vaccine containing tetanus toxoid, including ADACEL should be based on careful consideration of the potential benefits and possible risks.
ADACEL should not be administered to persons with progressive neurological disorder, uncontrolled epilepsy or progressive encephalopathy until a treatment regimen has been established and the condition has stabilized.
The immunogenicity of the vaccine could be reduced by immunosuppressive treatment or immunodeficiency. It is recommended to postpone the vaccination until the end of such disease or treatment if practical. Nevertheless, vaccination of HIV infected persons or persons with chronic immunodeficiency, such as AIDS, is recommended even if the antibody response might be limited.
Administration precautions: Do not administer by intravascular or intradermal injection.
Intramuscular injections should be given with care in patients on anticoagulant therapy or suffering from coagulation disorders because of the risk of haemorrhage. In these situations administration of ADACEL by deep subcutaneous injection may be considered, although there is a risk of increased local reactions.
Syncope (fainting) can occur following, or even before, administration of injectable vaccines, including ADACEL. Procedures should be in place to prevent falling injury and manage syncopal reactions.
The tip caps of the prefilled syringes contain a natural rubber latex derivative, which may cause allergic reactions in latex sensitive individuals.
Other considerations: As with any vaccine, vaccination with ADACEL may not protect 100% of susceptible individuals.
A persistent nodule at the site of injection may occur with all adsorbed vaccines, particularly if administered into the superficial layers of the subcutaneous tissue.
Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive or use machines have been performed. ADACEL has no or negligible influence on the ability to drive and use machines.
Adacel Polio: General: Before administration of ADACEL-POLIO, health-care providers should inform the recipient or parent or guardian of the recipient of the benefits and risks of immunization, inquire about the recent health status of the patient to be immunized, review the patient's history concerning possible hypersensitivity to the vaccine or similar vaccine, previous immunization history, the presence of any contraindications to immunization and comply with any local requirements regarding information to be provided to the patient/guardian before immunization.
It is extremely important that the recipient, parent or guardian be questioned concerning any signs or symptoms of an adverse reaction after a previous dose of vaccine (see Contraindications and Adverse Reactions.)
Syncope (fainting) has been reported following vaccination with ADACEL-POLIO.
Procedures should be in place to prevent falling injury and manage syncopal reactions. The rates and severity of adverse events in recipients of tetanus toxoid are influenced by the number of prior doses and level of pre-existing antitoxins.
As with any vaccine, ADACEL-POLIO may not protect 100% of vaccinated persons.
Administration Route Related Precautions: Do not administer ADACEL-POLIO by intravascular injection: ensure that the needle does not penetrate a blood vessel.
Intradermal or subcutaneous routes of administration are not to be utilized.
ADACEL-POLIO should not be administered into the buttocks.
Febrile and Acute Disease: Vaccination should be postponed in cases of an acute or febrile disease. However, a disease with low-grade fever should not usually be a reason to postpone vaccination.
Hematologic: Because any intramuscular injection can cause an injection site hematoma in persons with any bleeding disorders, such as hemophilia or thrombocytopenia, or in persons on anticoagulant therapy, intramuscular injections with ADACEL-POLIO should not be administered to such persons unless the potential benefits outweigh the risk of administration. If the decision is made to administer any product by intramuscular injection to such persons, it should be given with caution, with steps taken to avoid the risk of hematoma formation following injection.
Immune: The possibility of allergic reactions in persons sensitive to components of the vaccine should be evaluated. Hypersensitivity reactions may occur following the use of ADACEL-POLIO even in persons with no prior history of hypersensitivity to the product components.
As with all other products, epinephrine hydrochloride solution (1:1,000) and other appropriate agents should be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs. Health-care providers should be familiar with current recommendations for the initial management of anaphylaxis in non-hospital settings, including proper airway management. For instructions on recognition and treatment of anaphylactic reactions, see the current edition of the Canadian Immunization Guide or visit the Health Canada website.
Immunocompromised persons (whether from disease or treatment) may not achieve the expected immune response. If possible, consideration should be given to delaying vaccination until after the completion of any immunosuppressive treatment. Nevertheless, vaccination of persons with chronic immunodeficiency, such as HIV infection, is recommended even if the immune response might be limited.
Neurologic: ADACEL-POLIO should not be administered to individuals with progressive neurological disorder, uncontrolled epilepsy, or progressive encephalopathy until a treatment regimen has been established and the condition has stabilized.
A review by the US Institute of Medicine (IOM) found evidence for a causal relation between tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome. If Guillain-Barré syndrome has occurred within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give ADACEL-POLIO or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks.

Adacel: Pregnancy: ADACEL can be used during the second or third trimester of pregnancy in accordance with official recommendations (see Dosage & Administration).
Safety data from 4 randomized controlled trials (310 pregnancy outcomes), 1 prospective observational study (546 pregnancy outcomes), 5 retrospective observational studies (124,810 pregnancy outcomes), and from passive surveillance of women who received ADACEL or ADACEL-POLIO (Tdap-IPV; containing the same amounts of tetanus, diphtheria and pertussis antigens as ADACEL) during the second or third trimester have shown no vaccine-related adverse effect on pregnancy or on the health of the fetus/newborn child.
As with other inactivated vaccines, it is not expected that vaccination with ADACEL during any trimester would harm the fetus.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development.
For information on immune responses to vaccination during pregnancy and its effectiveness at preventing pertussis in infants, see Pharmacology: Pharmacodynamics under Actions.
Breast-feeding: It is not known whether the active substances included in ADACEL are excreted in human milk but antibodies to the vaccine antigens have been found to be transferred to the suckling offspring of rabbits. Two animal developmental studies conducted in rabbits have not shown any harmful effects of maternal antibodies induced by the vaccine on offspring postnatal development.
However, the effect on breast-fed infants of the administration of ADACEL to their mothers has not been studied. As ADACEL is inactivated, any risk to the infant is unlikely. The risks and benefits of vaccination should be assessed before making the decision to immunize a nursing woman.
Fertility: ADACEL has not been evaluated in fertility studies.
Adacel Polio: Pregnant Women: The effect of ADACEL-POLIO on the development of the embryo and fetus has not been assessed. Limited post-marketing data is available following administration of ADACEL-POLIO in pregnant women. Vaccination in pregnancy is not recommended unless there is a definite risk of acquiring pertussis. As the vaccine is inactivated, risk to the embryo or the fetus is improbable. The benefits versus the risks of administering ADACEL-POLIO during pregnancy should be carefully evaluated when there is a high probable risk of exposure to a household contact or during an outbreak in the community.
Nursing Women: The effect of administration of ADACEL-POLIO during lactation has not been assessed. As ADACEL-POLIO is inactivated, any risk to the mother or the infant is improbable. However, the effect on breast-fed infants of the administration of ADACEL-POLIO to their mothers has not been studied. The risks and benefits of vaccination should be assessed before making the decision to immunize a nursing woman.

Adacel: Summary of the safety profile: In clinical trials ADACEL was given to a total of 4,546 persons, including 298 children (4 to 6 years), 1,313 adolescents (11 to 17 years) and 2,935 adults (18 to 64 years). Most commonly reported reactions following vaccination included local reactions at the injection site (pain, redness and swelling) that occurred in 21% - 78% of the vaccinees, headache and tiredness that occurred in 16% - 44% of vaccinees. These signs and symptoms usually were mild in intensity and occurred within 48 hours following vaccination. They all resolved without sequelae.
Safety analysis was conducted in 1,042 healthy adolescent males and females aged 10 to 17 years during a clinical trial. They received quadrivalent human papillomavirus types 6/11/16/18 vaccine (Gardasil) concurrently with a dose of ADACEL and a dose of quadrivalent meningococcal conjugate vaccine serogroup A, C, Y and W135. The safety profiles were similar in both concomitant and non-concomitant groups. Higher frequencies of swelling at the Gardasil injection site, bruising and pain at ADACEL injection sites were observed in the concomitant administration group. The differences observed between concomitant and non-concomitant groups were less than 7% and in a majority of subjects the adverse events were reported as mild to moderate in intensity.
Tabulated list of adverse reactions: Adverse reactions are ranked under headings of frequency using the following convention: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known cannot be estimated from the available data.
Table 6 presents adverse reactions observed in clinical trials and also includes additional adverse events which have been spontaneously reported during the post-marketing use of ADACEL worldwide. Because post-marketing adverse events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Therefore, the frequency category "Not known" is assigned to these adverse events. (See Table 6.)

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Description of selected adverse reactions: General Disorders and Administration Site Conditions: Large injection site reactions (>50 mm), including extensive limb swelling from the injection site beyond one or both joints occur after administration of ADACEL in adolescents and adults. These reactions usually start within 24 - 72 hours after vaccination, may be associated with erythema, warmth, tenderness or pain at the injection site and resolve spontaneously within 3 - 5 days.
Paediatric population: The safety profile of ADACEL as presented in Table 6 includes data from a clinical trial in 298 children 4 to 6 years of age who had previously received a total of 4 doses, including primary immunization, with DTaP-IPV combined with Hib, at approximately 2, 4, 6 and 18 months of age. In this clinical study, the most common adverse events reported within 14 days post vaccination were pain at the injection site (in 39.6% of subjects) and tiredness (in 31.5% of subjects).
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Adacel Polio: Clinical Trial Adverse Drug Reactions: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to vaccine use and for approximating rates of those events.
The safety of ADACEL-POLIO has been evaluated in a total of 1,636 participants who received a single dose of ADACEL-POLIO in 7 clinical trials (644 children 3 to 7 years of age, 992 adolescents and adults 11 to 60 years of age). Pain was the most common injection site reaction in all age groups. Most injection site reactions occurred within 3 days following vaccination. The most frequent systemic reaction was headache in adolescents and adults and tiredness in children. These reactions were usually transient and of mild to moderate intensity.
Table 7 presents the frequencies of the solicited injection site and systemic adverse events reported in 3 UK clinical trials in which children previously primed with 3 doses of PEDIACEL [Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine and Haemophilus b Conjugate Vaccine (Tetanus Protein - Conjugate)] or a whole-cell pertussis combination vaccine, received a pre-school booster dose of ADACEL-POLIO at 3 to 5 years of age. In addition, adverse events of irritability (7.3%), injection site bruising (3.3%), injection site pruritus (2.7%) and dermatitis (1.3%) were reported within 7 days of vaccination in two of these studies.
In clinical trials in children ADACEL-POLIO showed a comparable safety profile to that of ADACEL [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed]. Therefore, the safety of ADACEL-POLIO, in particular for use as a 4 to 6 years-old booster dose is further supported by a study conducted with ADACEL in 298 children.
The frequency of the solicited injection site and systemic adverse events reported in a Canadian clinical trial in adolescents and adults are also presented in Table 7. (See Table 7.)

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Post-Market Adverse Drug Reactions: The following additional adverse events have been spontaneously reported during the post-marketing use of ADACEL-POLIO. Because these events are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.
Blood and Lymphatic Disorders: Lymphadenopathy.
Immune System Disorders: Anaphylactic reactions, such as urticaria, face edema and dyspnea.
Nervous System Disorders: Convulsions, vasovagal syncope, Guillain-Barre syndrome, facial palsy, myelitis, brachial neuritis, transient paresthesia/hypoesthesia of vaccinated limb, dizziness.
Musculoskeletal and Connective Tissue Disorders: Pain in vaccinated limb.
Gastrointestinal Disorders: Abdominal pain.
General Disorders and Administration Site Conditions: Extensive limb swelling, which may extend from the injection site beyond one or both joints and is frequently associated with erythema, and sometimes with blisters, has been reported following administration of ADACEL-POLIO. The majority of these reactions appeared within 48 hours of vaccination and spontaneously resolved over an average of 4 days without sequelae. The risk appears to be dependent on the number of prior doses of d/DTaP vaccine, with a greater risk following the 4th and 5th doses. Malaise, pallor, injection site induration.

Adacel: Based on the results of concomitant use clinical studies, ADACEL can be administered concomitantly with any of the following vaccines: inactivated Influenza vaccine, Hepatitis B vaccine, Inactivated or Oral Poliomyelitis vaccine and recombinant Human Papillomavirus vaccine (see Adverse Reactions) according to local recommendations.
Separate limbs must be used for the site of injection of concomitant parenteral vaccines. Interaction studies have not been carried out with other vaccines, biological products, or therapeutic medications. However, in accordance with commonly accepted immunization guidelines, since ADACEL is an inactivated product it may be administered concomitantly with other vaccines or immunoglobulins at a separate injection site.
In the case of immunosuppressive therapy, refer to Precautions.
Adacel Polio: Vaccine-Drug Interactions: Immunosuppressive treatments may interfere with the development of the expected immune response (see Precautions).
Concomitant Vaccine Administration: ADACEL-POLIO may be administered concurrently with a dose of hepatitis B vaccine. Supportive data from a study conducted with ADACEL suggests that ADACEL-POLIO may be used concomitantly with trivalent influenza vaccine. ADACEL POLIO has been safely administered concomitantly with measles-mumps-rubella vaccine in non-controlled clinical studies in children 3 to 5 years of age. Data are not available on concomitant use of ADACEL-POLIO and varicella vaccine.
Administering the most widely used live and inactivated vaccines during the same patient visit has produced seroconversion rates and rates of adverse reactions similar to those observed when the vaccines are administered separately. Vaccines administered concomitantly should be given using separate syringes at separate sites. Simultaneous administration is suggested, particularly when there is concern that a person may not return for subsequent vaccination.
ADACEL-POLIO should not be mixed in the same syringe with other parenterals.

Adacel: Incompatibilities: In the absence of compatibility studies, ADACEL must not be mixed with other medicinal products.
Special precautions for disposal: Instructions for use: Parenteral products should be inspected visually for extraneous particulate matter and/or discolouration prior to administration. In the event of either being observed, discard the medicinal product.
The normal appearance of the vaccine is a uniform, cloudy, white suspension which may sediment during storage. Shake the vial well to uniformly distribute the suspension before administering the vaccine.
Disposal: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Needles should not be recapped.

Store at 2° to 8°C (35° to 46°F). Do not freeze. Discard product if exposed to freezing.

Vaccines, Antisera & Immunologicals

J07CA02 - diphtheria-pertussis-poliomyelitis-tetanus ; Belongs to the class of combined bacterial and viral vaccines.
J07AJ52 - pertussis, purified antigen, combinations with toxoids ; Belongs to the class of pertussis bacterial vaccines.

Adacel: P₁S₁S₃, Adacel Polio: P₁S₁S₃, A