Adacel

Each single dose (0.5 mL) contains: Tetanus Toxoid 5 Lf; Diphtheria Toxoid 2 Lf; Component Pertussis: Pertussis Toxoid 2.5 µg, Filamentous Haemagglutinin 5 µg, Fimbrial agglutinogens 2+3 5 µg, Pertactin 3 µg; Aluminum Phosphate (aluminum 0.33mg) 1.5 mg; 2-phenoxyethanol 0.6% (v/v); Residual formaldehyde ≤5 µg; Residual glutaraldehyde < 50 µg.
ADACEL [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed] is a sterile, uniform, cloudy, white suspension of tetanus and diphtheria toxoids adsorbed separately on aluminum phosphate, combined with acellular pertussis vaccine and suspended in water for injection. The acellular pertussis vaccine is composed of 5 purified pertussis antigens (PT, FHA, PRN and FIM).

ADACEL is indicated for active booster immunization for the prevention of tetanus, diphtheria and pertussis (whooping cough) in person 4 to 6 years of age and 10 years or older.
ADACEL is indicated for passive protection against pertussis in early infancy following maternal immunization during pregnancy (see DOSAGE & ADMINISTRATION and PRECAUTIONS).
ADACEL should be used in accordance with official recommendations.
In accordance with local recommendations, Adacel may be considered as an alternative for the fifth dose of tetanus, diphtheria and acellular pertussis vaccine (DTaP) (TDap) in children 4 to 6 years of age, concomitantly administered with inactivated Poliomyelitis Vaccine (IPV) at separate sites to complete the vaccination series of this age when indicated.
ADACEL is not to be used for the treatment of disease caused by Bordetella pertussis, Corynebacterium diphtheriae or Clostridium tetani infections.
Pediatrics: ADACEL is not indicated for immunization of children below the age of 4 years.
Tetanus Prophylaxis in Wound Management: The need for active immunization with a tetanus toxoid-containing preparation such as Td adsorbed vaccine or Adacel, with or without passive immunization with tetanus Immune Globulin, depends on both the condition on the wound and the patients vaccination history.

Recommended Dose: ADACEL (0.5 mL) should be administered as a booster injection by the intramuscular route.
Re-dosing with ADACEL can be used to boost immunity to diphtheria, tetanus and pertussis at 5 to 10 years intervals.
The preferred site is into the deltoid muscle.
Fractional doses (doses <0.5 mL) should not be given. The effect of fractional doses on the safety and efficacy has not been determined.
ADACEL may be administered to pregnant women from 24 - 36 weeks gestation to provide passive protection of infants against pertussis (see INDICATIONS and PRECAUTIONS). (See Table 1.)


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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.
Method of Administration: Inspect for extraneous particulate matter and/or discolouration before use. (See DESCRIPTION). If these conditions exist, the product should not be administered.
Shake the vial well until a uniform, cloudy, suspension results. Cleanse the vial stopper with a suitable germicide prior to withdrawing the dose. Do not remove either the stopper or the metal seal holding it in place. Aseptic technique must be used. Use a separate sterile needle and syringe, or a sterile disposable unit for each individual recipient, to prevent disease transmission. Needles should not be recapped but should be disposed of according to biohazard waste guidelines. (See PRECAUTIONS).
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.
Posology: Re-dosing with ADACEL can be used to boost immunity to diphtheria, tetanus and pertussis at 5 to 10 years intervals.

Hypersensitivity: Known systemic hypersensitivity reaction to any component of ADACEL 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. (See CONTENTS, DESCRIPTION, and PRESENTATION). 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 pertussis-containing vaccine not attributable to another identifiable cause is a contraindication to vaccination with any pertussis-containing vaccine, including ADACEL.

General: Before administration of ADACEL, health-care providers should inform the recipient or the parent or guardian of the recipient of the benefit and risk of immunization, inquire about the recent health status of the recipient, review the recipient'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 recipient/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).
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.
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.
As with any vaccine, ADACEL may not protect 100% of vaccinated persons.
Data indicate that maternal antibodies may reduce the magnitude of the immune response to some vaccines in infants born to women vaccinated with ADACEL during pregnancy and showed the lower concentration of antibodies to the antigen pertussis in infants receiving primary and booster vaccine.
The clinical relevance of this observation is unknown.
Arthus-type hypersensitivity reactions characterized by severe local reactions (generally starting 2 to 8 hours after an injection), may follow receipt of tetanus toxoid. Such reactions may be associated with high levels of circulating antitoxin in persons who have had overly frequent injections of tetanus toxoid.
Administration Route Related Precautions: Do not administer ADACEL 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 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 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 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.
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 should not be administered to individuals with progressive or unstable neurological disorders, uncontrolled epilepsy or progressive encephalopathy until a treatment regimen has been established, the condition has stabilized and the benefit clearly outweighs the risk.
If Guillain-Barré syndrome occurred within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give ADACEL or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks.
A few cases of demyelinating diseases of the central nervous system, peripheral mononeuropathies and cranial mononeuropathies have been reported following vaccines containing tetanus and or diphtheria toxoids, although the IOM concluded that the evidence is inadequate to accept reject a causal relation between these conditions and vaccination.
Use in Pregnancy: Adacel should be administered between weeks 24 and 36 of pregnant to provide passive protection to young infants.
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), all conducted in pregnant women, and from passive surveillance of women who received ADACEL or ADACEL-POLIO (Tdap-IPV; containing the same amounts of tetanus, diphtheria and pertussis antigen as ADACEL) have shown no vaccine-related adverse effect on pregnancy or on the health of the fetus/newborn child. No unexpected adverse events were observed following vaccination of pregnant women with Adacel. The most common adverse events were injection site reactions. The adverse event profile for Adacel in pregnancy is similar to the profile when given to non-pregnant women (see ADVERSE REACTIONS). As with other inactivated vaccines, it is not expected that vaccination with ADACEL during any trimester would harm the fetus.
Although some observational studies report a slight increase in chorioamnionitis when Tdap vaccine has been given to pregnant women, this has not been associated with adverse outcomes for the pregnant women or their newborns. The causal association between Tdap vaccine and chorioamnionitis has not been established.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development.
Limited clinical data have shown there is interference with the immune response to other antigens (i.e. diphtheria, tetanus, polio, pneumococcal, meningococcal) in infants born to women vaccinated with ADACEL during pregnancy. However, in most of the cases, the antibody concentrations remain above the thresholds established as protective. The clinical relevance of this observation is unknown.
Passive protection of neonates and infants against pertussis: Based on findings from multiple studies of ADACEL and ADACEL-POLIO administered to pregnant women: Pertussis antibody responses in pregnant women are generally similar to those in non-pregnant women; Maternal antibody directed against pertussis antigens persists for 2 to 4 months after birth and may be associated with blunting of the infant immune response to active immunization against pertussis (see General as previously mentioned); The effectiveness of maternal immunization against pertussis in the first 3 months of life has been estimated to be >90%. (See Table 2.)


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Use in Lactation: The effect of administration of ADACEL during lactation has not been assessed. As ADACEL is inactivated, any risk to the mother or the infant is improbable. However, the effect on breast-fed infants of the administration of ADACEL 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.

Pregnant Women: Adacel should be administered between weeks 24 and 36 of pregnant to provide passive protection to young infants.
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), all conducted in pregnant women, and from passive surveillance of women who received ADACEL or ADACEL-POLIO (Tdap-IPV; containing the same amounts of tetanus, diphtheria and pertussis antigen as ADACEL) have shown no vaccine-related adverse effect on pregnancy or on the health of the fetus/newborn child. No unexpected adverse events were observed following vaccination of pregnant women with Adacel. The most common adverse events were injection site reactions. The adverse event profile for Adacel in pregnancy is similar to the profile when given to non-pregnant women (see ADVERSE REACTIONS). As with other inactivated vaccines, it is not expected that vaccination with ADACEL during any trimester would harm the fetus.
Although some observational studies report a slight increase in chorioamnionitis when Tdap vaccine has been given to pregnant women, this has not been associated with adverse outcomes for the pregnant women or their newborns. The causal association between Tdap vaccine and chorioamnionitis has not been established.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development.
Limited clinical data have shown there is interference with the immune response to other antigens (i.e. diphtheria, tetanus, polio, pneumococcal, meningococcal) in infants born to women vaccinated with ADACEL during pregnancy. However, in most of the cases, the antibody concentrations remain above the thresholds established as protective. The clinical relevance of this observation is unknown.
Passive protection of neonates and infants against pertussis: Based on findings from multiple studies of ADACEL and ADACEL-POLIO administered to pregnant women: Pertussis antibody responses in pregnant women are generally similar to those in non-pregnant women; Maternal antibody directed against pertussis antigens persists for 2 to 4 months after birth and may be associated with blunting of the infant immune response to active immunization against pertussis (see General under PRECAUTIONS); The effectiveness of maternal immunization against pertussis in the first 3 months of life has been estimated to be >90%. (See Table 2.)


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Nursing Women: The effect of administration of ADACEL during lactation has not been assessed. As ADACEL is inactivated, any risk to the mother or the infant is improbable. However, the effect on breast-fed infants of the administration of ADACEL 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.

Clinical Trials Adverse 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 the 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 was evaluated in a total of 4,648 participants who received a single dose of ADACEL in 5 clinical trials (298 children ≥4 years of age, 1,508 adolescents and 2,842 adults).
Pain at the injection site was the most common solicited injection site reaction. Most injection site reactions occurred within 3 days following vaccination and their mean duration was less than 3 days. The most frequent systemic reaction was tiredness in children and headache in adolescents and adults. Fever was reported in less than 10% of vaccinees.
These reactions were usually transient and of mild to moderate intensity. In addition, in adolescents and adults the incidence of injection site and systemic reactions following ADACEL were significantly lower than those observed with a Td vaccine booster. In children the observed frequencies of injection site reactions and fever following ADACEL were significantly lower than those observed with QUADRACEL (DTaP-IPV) when administered as a booster at 4 to 6 years of age. Except for fever, the observed rates for the systemic reactions were comparable between the two vaccines. The frequency of the solicited injection site and systemic reactions reported in two clinical trials are shown in Table 3. (See Table 3.)


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Immune System Disorders: Hypersensitivity (anaphylactic) reaction (angioedema, edema, rash, hypotension).
Nervous System Disorders: Paraesthesia, hypoesthesia, Guillain-Barré syndrome, brachial neuritis, facial palsy, convulsion, syncope, myelitis.
Cardiac Disorders: Myocarditis.
Skin and Subcutaneous Tissue Disorders: Pruritus, urticaria.
Musculoskeletal and Connective Tissue Disorders: Myositis, muscle spasm.
General Disorders and Administration Site Conditions: Large injection site reactions (>50 mm) and extensive limb swelling from the injection site beyond one or both joints have been reported 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. The risk appears to be dependent on the number of prior doses of acellular pertussis containing vaccine. Injection site bruising, sterile abscess.

Vaccine-Drug Interactions: Immunosuppressive treatments may interfere with the development of the expected immune response. (See PRECAUTIONS).
Concomitant Vaccine Administration: ADACEL may be administered concurrently with a dose of trivalent inactivated influenza vaccine and with a dose of hepatitis B vaccine in 11 to 12 years old.
The concomitant use of ADACEL and trivalent inactivated influenza vaccine was evaluated in a clinical trial involving 696 adults 19 to 64 years of age. Booster response rates for diphtheria were non inferior when ADACEL was administered concurrently with influenza vaccine compared to separate administration. Although tetanus booster responses rates did not meet the non inferiority criterion, greater than 98% of participant in both groups achieved seroprotective levels of ≥ 0.1 IU/mL. Post vaccination pertussis antibody GMCs for both vaccine groups were robust, and non inferiority was achieved for PT, FHA and FIM. For PRN, the lower limit of the 90% CI of the GMC ratio was slightly lower (0.61) as compared to the non inferiority criterion.
Vaccines administered simultaneously should be given using separate syringes at separate injection sites and preferably in separate limbs. ADACEL should not be mixed in the same syringe with other parenterals.

Store at 2° to 8°C. Do not freeze. Discard product if exposed to freezing (≤0°C).
Shelf-life: 36 months.

Vaccines, Antisera & Immunologicals

J07AJ52 - pertussis, purified antigen, combinations with toxoids ; Belongs to the class of pertussis bacterial vaccines.

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