Geometric Mean Titre (EU/ml)

                                    After 3rd dose with tripacel in Infants.                     After 4th dose     After 1 dose
                                                                                                                        with Pentacel       of Adacel

Indications: Prevention of tetanus, diphtheria and whooping cough in adolescents and adults aged 12 to 54 years. Human Immunodeficiency Virus (HIV)-lnfected Persons: HIV-infected individuals, both asymptomatic and symptomatic, should be immunized against diphtheria, pertussis and tetanus according to standard schedules.

Persons who have had tetanus or diphtheria should still be immunized since these clinical infections do not always confer immunity. Those who have had natural pertussis can continue to receive pertussis-containing vaccines.

Contraindications: General: Immunization with Adacel should be deferred in the presence of any acute illness, including febrile illness to avoid superimposing adverse effects from the vaccine on the underlying illness or mistakenly attributing to the vaccine a manifestation of the underlying illness. A minor afebrile illness such as mild upper respiratory infection is not usually a reason to defer immunization.

Absolute Contraindications: Allergy to any component of Adacel (see Supplied) or an anaphylactic or other allergic reaction to a previous dose of Td Adsorbed or another component pertussis combination vaccine are contraindications to vaccination.

Warnings: I.M. injections should be given with care in patients suffering from coagulation disorders because of the risk of hemorrhage.

If Adacel is used in poisons with malignancies, persons receiving immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, or persons who are otherwise immunocompromised (including HIV-infected individuals, transplant recipients, persons suffering from autoimmune disorders), the expected immune response may not be obtained.

Corticosteroid therapy can result in immunosuppression although the exact dose and duration of therapy required to suppress the immune system is not well defined. Persons treated with high doses of systemic steroids, e.g., ≥ 2 mg/kg/day of prednisone orally for more than 2 weeks, should be considered to have a compromised immune system. As with any vaccine, immunization with Adacel may not protect 100% of susceptible individuals.

The use of fractional doses in an attempt to reduce the severity of adverse reactions cannot be recommended because there is insufficient evidence on the safety or efficacy of such smaller doses.

Precautions: General: The possibility of allergic reactions in individuals sensitive to components of the vaccine should be evaluated. Epinephrine HCI solution (1:1000) and other appropriate agents should be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs- Healthcare providers should be familiar with current recommendations for the initial management of anaphylaxis in non-hospital settings, including proper airway management.

Before administration of any vaccine, appropriate precautions should be taken to prevent adverse reactions. This includes a review of the patient's history with respect to possible hypersensitivity to the vaccine or similar vaccine, determination of previous immunization history, and the presence of any contraindications to immunization, current health status, and knowledge of the current literature concerning the use of the vaccine under consideration.

Frequent booster doses of tetanus or diphtheria toxoids in the presence of adequate or excessive serum levels of tetanus or diphtheria antitoxins have been associated with increased incidence and severity of reactions and should be avoided. If hypersensitivity to the diphtheria component is suspected, tetanus toxoid should be used for reinforcing doses. Special care should be taken to ensure that the product is not injected into a blood vessel (see Dosage).

Caution: A separate, sterile needle and syringe or a sterile disposable unit must be used for each individual patient to prevent the transmission of infectious agents.

There have been case reports of transmission of HIV and hepatitis by failure to scrupulously observe sterile technique. Needles should not be recapped and should be disposed of properly.

Before administration of Adacel, healthcare personnel should inform the patient or parent or guardian of the patient to be immunized of the benefits and risks of immunization, inquire about the recent health status of the patient and comply with any local requirements with respect to information to be provided to the patient before immunization.

Pregnancy and Lactation: The effect of Adacel on the development of the embryo and fetus has not been assessed. Vaccination in pregnancy is not recommended, unless there is a definite risk of acquiring pertussis. As the vaccine is inactivated, any risk to the embryo or the fetus is highly improbable. The benefits versus the risks of administering Adacel in pregnancy should carefully be evaluated when there is a high probable risk of exposure to a household contact or during an outbreak in the community.

The effect of administration of Adacel during lactation has not been assessed. As Adacel is inactivated, any risks to the mother or the infant are highly improbable. The benefits versus the risks of administering Adacel during lactation should carefully be evaluated by the healthcare provider, particularly when there is a high probable risk of disease transmission through exposure to a household contact, or during an outbreak in the community. The risks of disease transmission from the infected mother to the infant who may not have been fully immunized should also be evaluated.

Adverse Effects: In a clinical trial with 749 adolescents and adults given Adacel (n=449) or Td Adsorbed (n=15l), adverse events following Adacel were primarily localized to the site of injection. Pain was the most common local reaction (88.6%), while erythema and swelling were reported in 11.8% and 16.7%, respectively. These local adverse events were generally mild and transient in duration. Systemic adverse events that were reported after vaccination with Adacel were: fever (9.4%), vomiting (2.4%), headache (38.8%), diarrhea (10.0%), nausea (14.7%), chills (12.5%), generalized bodyache (20.0%), decreased energy (29.4%), and sore or swollen joints (9.1%). Of the 38.8% that reported headaches, 72.9% were mild and less than 5% were categorized as severe by the vaccinee. While decreased energy was common (29.4%), only 8.9% of vaccines considered it as significant. The adverse event rates observed with Adacel were comparable to those seen with the group that received Td Adsorbed (see Table II).

Table II – Adacel
Rate (%) of Adverse Events Reported After Vaccination With Adacel Compared to Td Adsorbed

Adverse Event Rate %
TD – Adverse Events Severity Adacel Adsorbed

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Localized reactions consisting of discomfort, pain, swelling and redness at the injection site may be associated with tetanus and diphtheria toxoids. Following booster doses, local erythema and swelling are not uncommon and Arthus-type sensitivity may occur. Severe local reactions are often associated with high levels of circulating antitoxin, usually resulting from over-immunization due to toxoid being given too frequently.

Systemic reactions, such as generalized urticaria, are uncommon. Influenza-like symptoms have been reported and usually occur within12 hours of vaccination with some diphtheria and tetanus toxoids.

Neurological complications such as peripheral neuropathies and demyelinating diseases of the CNS following tetanus toxoid or diphtheria toxoid have been documented but are rare. The US Institute of Medicine has concluded that the evidence is inadequate to accept or reject a causal relation between tetanus toxoid, DT or Td and demyelinating diseases of the CNS (acute demyelinating encephalomyelitis, transverse myelitis- optic neuritis) or peripheral mononeuropathy (other than those caused by direct intraneural injection).

The following neurologic illnesses have been reported as temporally associated with some vaccines containing tetanus toxoid: neurological complications including cochlear lesion, brachial plexus neuropathies, paralysis of the radial nerve, paralysis of the recurrent nerve, accommodation paresis, and EEG disturbances with encephalopathy (with or without permanent intellectual and/or motor function impairment). In the differential diagnosis of polyradiculoneuropathies following administration of a vaccine containing tetanus toxoid, tetanus toxoid should be considered as a possible etiology. The Institute of Medicine concluded that the evidence favors acceptance of a causal relation between tetanus toxoid and brachial neuritis.

On the basis of a case report and evidence that a vaccine-induced immunologic response can cause Guillain-Barre Syndrome (GBS), the Institute of Medicine concluded that tetanus toxoid-containing vaccines can trigger GBS in adults. No increased risk for GBS has been observed with the use of DPT in children.

Persistent nodules at the site of injection have occurred following the use of an adsorbed product, but this complication is unusual, and may be related to s.c. administration. Sterile abscess at the site of injection has been reported following use of some adsorbed vaccines (6 to 10 per million doses).

Rare cases of allergic or anaphylactic reaction (i.e., hives, swelling of the mouth, difficulty breathing, hypotension, or shock) have been reported after receiving some preparations containing diphtheria, tetanus and/or pertussis antigens. Death following vaccine-caused anaphylaxis has been reported.

As with any vaccine, there is the possibility that broad use of the vaccine could reveal rare adverse reactions not observed in clinical trials.

Physicians, nurses, and pharmacists should report any adverse occurrences temporally related to the administration of the product in accordance with local requirements and report to the Medical Director at Aventis Pasteur Limited, 1755 Steeles Avenue West, Toronto, Ontario, Canada, M2R 3T4.

Dosage: For persons who have previously been immunized against tetanus, diphtheria, and pertussis a dose of 0.5 mL should be administered as a reinforcing dose.

There are currently no data upon which to base a recommendation for the optimal interval for administering subsequent booster doses with Adacel.

Tetanus Prophylaxis in Wound Management: Table III summarizes the recommended use of immunizing agents in wound management. It is important to ascertain the number of doses of tetanus toxoid previously given and the interval since the last dose. If not clearly documented, a history of immunization should be regarded as "uncertain". When a tetanus booster dose is required, a combined preparation formulated for adults including tetanus and diphtheria toxoid is preferred. Appropriate cleansing and debridement of the wound is imperative. Booster doses given more frequently than recommended below may lead to adverse local and systemic reactions.

When travel to a developing country is planned more than 5 years after the last tetanus booster, it may be prudent to offer an early booster, since in some developing countries healthcare facilities may not be able to guarantee the safe administration of a booster dose if required.

Table III – Adacel
Recommended Use of Immunizing Agents

                                    Clean Minor Wounds                 All Other Wounds

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(a) Adult type tetanus and diphtheria toxoid combination vaccine. If the patient is < 7 years old, an appropriate tetanus combination vaccine such as Tripacel or Pentacel is given.

(b)Primary immunization is at least 3 doses at age appropriate intervals.

(c)Tetanus immune globulin.

(d)Yes, unless there is documentation of a booster within the last 10 years.

(e)Yes, unless there is documentation of a booster within the last 5 years.

(f)No, unless individuals are known to have a significant immune deficiency state (e.g., HIV, agammaglobulinemia) since immune response to tetanus toxoid may be suboptimal.

Note: Tetanus toxoid, or a combined vaccine containing tetanus toxoid, and tetanus immune globulin should be administered in separate syringes at different sites.

Parenteral biological products should be inspected visually for extraneous particulate matter and/or discoloration before administration. If these conditions exist, the product should not be administered.

Shake the vial well to distribute uniformly the suspension before withdrawing each dose. When administering a dose from a rubber-stoppered vial, do not remove either the rubber stopper or the metal seal holding it in place. Aseptic technique must be used for withdrawal of each dose (See Precautions).

Before injection, the skin over the site to be injected should be cleansed with a suitable germicide. Administer the vaccine i.m. The preferred site is into the deltoid muscle.

After insertion of the needle, aspirate to ensure that the needle has not entered a blood vessel.

Do not inject i.v.

Each person who is immunized should be given a permanent personal immunization record. In addition, it is essential that the physician or nurse record the immunization history in the permanent medical record of each patient. This permanent office record should contain the name of the vaccine, date given, dose, manufacturer and lot number.

Supplied: Adacel is a sterile, cloudy, uniform suspension of tetanus and diphtheria toxoids adsorbed on aluminum phosphate, combined with component pertussis vaccine and suspended in water for injection. Component pertussis vaccine is an acellular pertussis vaccine composed of 5 purified pertussis antigens.

Each dose (0.5 mL) contains: tetanus toxoid 5 Lf (T), diphtheria toxoid 2 Lf (d), pertussis toxoid (PT) 2.5 µg, filamentous haemagglutinin (FHA) 5 µg, fimbriae (agglutinogens 2+3) 5 µg, pertactin (69 kDa membrane protein) 3µg, aluminum phosphate 1.5 mg (0.33 mg aluminum) and 0.6% ± 0.1% (v/v) 2-phenoxyethanol as preservative. Single vials of 0.5 mL, packages of 1 and 5.

Store at 2 to 8°C. Do not freeze. Product which has been exposed to freezing should not be used. Do not use after expiration date.

New Product 2000

PENTACEL™ New Product 1997 98 99 2000 Connaught 01 02 03 Aventis Pasteur

PENTACEL_E PDF (english)
PENTACEL_E PDF (french)

Haemophilus b Conjugate Vaccine (Tetanus Protein-Conjugate)—Component Pertussis Vaccine—Diphtheria and Tetanus Toxoids Adsorbed Combined with Inactivated Poliomyelitis Vaccine Active Immunizing Agent.

Supplied: Pentacel is a comarketing of 2 licensed vaccines: the lyophilized Haemophilus b Conjugate Vaccine (Tetanus Protein-Conjugate)-Act-HIB to be reconstituted with Component Pertussis Vaccine and Diphtheria and Tetanus Toxoids Adsorbed Combined with Inactivated Poliomyelitis Vaccine- Quadracel. Each 0.5 mL i.m. Act-HIB dose contains: 10 µg purified capsular polysaccharide covalently bound to 20 µg tetanus protein. Each 0.5 mL dose contains: pertussis toxoid 20 µg filamentous hemagglutinin 20 µg, fimbriae 5 µg, pertactin 3 µg, diphtheria toxoid 15 Lf, tetanus toxoid 5 Lf, inactivated poliomyelitis vaccine, aluminum [2000, 2001, 2002 2003 say aluminum phosphate] and 2-phenoxyethanol as a preservative. Trace amounts of polymyxin B and neomycin may be present from the cell growth medium.

Each package contains: 5x single dose vials Act-HIB, 5x0.5 mL ampuls (single dose) Quadracel and direction leaflets for each product. For instructions for reconstitution with Quadracel, see the Act-HIB direction leaflet. Store between 2 and 8°C. Do not freeze.

New Product 1997