Diphtheria/ Tetanus/ Acellular Pertussis (Tdap)

Registered South African indications:

• Active booster immunisation for the prevention of tetanus, diphtheria and pertussis (whooping cough) according to local immunisation recommendations
• Passive immunisition against pertussis in early infancy following maternal immunisation during pregnancy 
• Management of tetanus prone injuries with or without coadministration of tetanus immunoglobulin in accordance with official recommendations

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Diphtheria/ Tetanus/ Acellular Pertussis (Tdap) should not be administered to anyone with a history of severe allergic reaction to any component of the vaccine or after a previous administration of the vaccine or a vaccine containing the same components or constituents
• Generally, vaccination must be postponed in cases of moderate or severe febrile and/or acute disease. Low-grade fever does not constitute a contraindication
• Encephalopathy within 7 days of a previous dose of pertussis-containing vaccine not attributable to another identifiable cause, is a contraindication to vaccination with Tdap (See additional prescribing points)  

Cautions

• Hypersensitivity to formaldehyde and glutaraldehyde (See additional prescribing points)
• Pregnancy (first trimester)
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Guillain-Barré syndrome or brachial neuritis following prior vaccine containing tetanus toxoid
• Progressive or unstable neurological disorders
• Uncontrolled epilepsy 
• Progressive encephalopathy
• Immunocompromised persons (See additional prescribing points)
  - Whether from disease or treatment
• Thrombocytopaenia
• Bleeding disorders
• Pre-existing antitoxins

Forms avail. in SA and covered in this monograph: vac

Dosages below include:

• South African registered indications and dosages

South African registered indications and dosages

Active booster immunisation for the prevention of tetanus, diphtheria and pertussis (whooping cough) according to local immunisation recommendations 
Management of tetanus-prone wounds or injuries with or without coadministration of tetanus immunoglobulin in accordance with official recommendations

• IM: 0.5ml, as a single dose 

Persons who have had pertussis, tetanus or diphtheria, should still be immunised since these clinical infections do not always confer immunity

Tdap should be administered as a booster injection by the intramuscular route. Re-dosing can be used to boost immunity to diphtheria, tetanus and pertussis at 5-10 year intervals

The use of the vaccine in the management of tetanus-prone wounds should follow local recommendations. A thorough attempt must be made to determine whether a patient has completed primary immunisation. Persons who have completed primary immunisation 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, faeces, soil and saliva, puncture wounds, avulsions and wounds resulting from measles, crushing, burns or frostbite), a booster is appropriate if the patient has not received a tetanus toxoid-containing preparation within the preceding 5 years

Fractional doses (doses <0.5ml) should not be given

The preferred site of injection is the deltoid muscle. Do not administer IV or into the gluteal area. Intradermal or SC routes should not be used

Separate syringes, separate injection sites and preferably separate limbs must be used in case of concomitant administration

Paed. forms avail. in SA and covered in this monograph: vac

Dosages below include:

• South African registered indications and dosages

South African registered indications and dosages

Active booster immunisation for the prevention of tetanus, diphtheria and pertussis (whooping cough) according to local immunisation recommendations
Management of tetanus-prone wounds or injuries with or without coadministration of tetanus immunoglobulin in accordance with official recommendations

Younger than 4 years

• Not established for use 

Older than 4 years 

• IM: 0.5ml, as a single dose

Passive immunisation against pertussis in early infancy following maternal immunisation during pregnancy
- Administered during the second and third trimester

• See adult dosage (adult active immunisation is dosage applicable for pregnant women)

Persons who have had pertussis, tetanus or diphtheria, should still be immunised since these clinical infections do not always confer immunity

Tdap should be administered as a booster injection by the intramuscular route. Re-dosing can be used to boost immunity to diphtheria, tetanus and pertussis at 5-10 year intervals

Management of tetanus-prone wounds or injuries should follow local recommendations. No specific paediatric dosage recommendations stated on South African manufacturer recommendations

Fractional doses (doses <0.5ml) should not be given

The preferred site of injection is the deltoid muscle. Do not administer IV or into the gluteal area. Intradermal or SC routes should not be used

Separate syringes, separate injection sites and preferably separate limbs must be used in case of concomitant administration

Pregnancy

• First trimester: Caution; no evidence of risk in studies
• Second and third trimester: Safe; no evidence of risk in studies
• Safety data from 4 randomized controlled trials (310 pregnancy outcomes), 1 prospective observational studies (546 pregnancy outcomes), 5 retrospective observational studies (124810 pregnancy outcomes), and from passive surveillance of women who received the Tdap or Tdap-IPV vaccine (containing the containing the same amounts of tetanus, diphtheria and pertussis antigens as Tdap) during the 2nd or 3rd trimester have shown no vaccine-related adverse effect on pregnancy or on the health of the foetus/ newborn child
• As with other inactivated vaccines, it is not expected that vaccination with the Tdap vaccine during any trimester would harm the foetus
• Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development
• 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 foetus

Breastfeeding

• Caution; no information available 
• It is not known whether the active substances included in the Tdap vaccine 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
• The effect of administration of Tdap during breastfeeding has not been assessed. As the Tdap vaccine is inactivated, any risk to the mother or the infant is improbable
• The risks and benefits of vaccination should be assessed before making the decision to immunise a breastfeeding woman

Fertility

• Tdap vaccine has not been evaluated in fertility studies

Renal Impairment

• Caution; no information available

Hepatic Impairment

• Caution; no information available

Elderly

• No dose adjustment recommended 

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Tiredness (18-64 years of age)
• Malaise (≥65 years of age)
• Headache
• Paraesthesia
• Hypoesthesia
• Guillain-Barré syndrome
• Brachial neuritis
• Facial palsy
• Seizures
• Syncope
• Myelitis

Cardiovascular Disorders 

• Myocarditis

Gastrointestinal Disorders 

• Nausea and vomiting
• Diarrhoea

Endocrine and Metabolic Disorders 

• Anorexia

Musculoskeletal Disorders 

• Body ache or muscle weakness (18-64 years of age)
• Myalgia (≥65 years of age)
• Sore or swollen joints
• Myositis

Skin and Subcutaneous Tissue Disorders 

• Rash
• Large injection site reactions (>50mm)
• Injection site reactions
  - Pain
  - Swelling
  - Erythema/redness
  - Extensive limb swelling (beyond one or both joints)
  - Warmth
  - Tenderness
  - Bruising
  - Sterile abscess
• Pruritus
• Urticaria

Immune, Blood and Lymphatic System Disorders 

• Fever
• Chills
• Axillary lymph node swelling
• Hypersensitivity (anaphylactic) reaction
  - Angioedema
  - Oedema
  - Rash
  - Hypotension

• Immunosuppressive therapy

Observations

• Anaphylaxis and syncope (15 mins after administration)

Immunocompromised persons

• Immunocompromised persons (whether from disease or treatment) may not obtain the expected immune response
• If possible, consideration should be given to delaying vaccination until after the completion of any immunosuppressive treatment
• Nevertheless, vaccination of subjects with chronic immunodeficiency, such as HIV infection, is recommended even if the immune response might be limited

Rare anaphylactic events after use

• As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following administration of the vaccine
• The rates and severity of adverse events in recipients of tetanus toxoid are influenced by the number or prior doses and level of pre-existing antitoxins

Hypersensitivity

• Formaldehyde and glutaraldehyde have been used in the manufacturing process of the Tdap vaccine and trace residual amounts may be present in the final product. Therefore, a hypersensitivity reaction may occur

Coadministration with other vaccines

• The vaccine may be administered concurrently with influenza vaccine, hepatitis B vaccine, inactivated or oral poliomyelitis vaccine and human papillomavirus vaccine
• In accordance with national recommendations, other live or inactivated parenteral vaccines may be administered simultaneously, as appropriate for the recipient’s age and previous vaccination status
• Separate injection sites, separate syringes and preferably separate limbs must be used in case of concomitant administration and the vaccine must not be mixed with other vaccines or medicinal products

Instructions for use and handling

• Inspect the vial for extraneous particulate matter and/or discolouration before use. If these conditions exist, do not administer Tdap. Shake the vial well before use until a uniform, cloudy suspension results
• Aseptic technique must be used to withdraw the dose
• Use a separate sterile needle and syringe, or a sterile disposable unit, for each recipient
• Store in a refrigerator at 2-8°C
• Do not freeze. Discard the vaccine if it has been frozen
• Protect from light. Keep the vial in the outer carton until required for use

The diphtheria, tetanus, acellular pertussis vaccine (Tdap) induces specific active immunity against diphtheria, tetanus and pertussis.

COMBINATION PREPARATIONS

Diphtheria/ Tetanus/ Acellular Pertussis (Tdap)

Vaccine 0.5ml

• Adacel (Sanofi Aventis South Africa) originator