Diphtheria/ Tetanus/ Acellular Pertussis (DTaP)

Registered South African indications:

• Primary immunisation against diphtheria, tetanus and pertussis
• Booster doses (4^th and 5^th dose) following the primary vaccination with either the DTaP vaccine or the DTPw (whole-cellular vaccine)

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Signs of hypersensitivity after previous administration of the vaccine or to a vaccine containing the same components or constituents; such as the diphtheria/ tetanus/ acellular pertussis vaccine, diphtheria, tetanus and DTPw vaccines
• Encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with a pertussis-containing vaccine

Cautions

• Renal impairment
• Hepatic impairment
• Progressive neurological disorders
• Infantile spasms
• Uncontrolled epilepsy 
• Progressive encephalopathy
• Impaired immune response (See additional prescribing points)
  - Patients receiving immunosuppressive therapy
  - HIV infection
• Thrombocytopaenia 
• Bleeding disorders
• Events that occur in temporal relation to prior immunisation with pertussis component of vaccine 
  - Temperature of ≥40,5°C within 48 hours, not due to another identifiable cause
  - Generalised collapse or shock-like state (hypotonic-hyporesponsive episode) within 48hrs of vaccination
  - Bronchospasm or laryngeal oedema
  - Persistent, inconsolable crying lasting ≥3hrs, occurring within 48hrs of vaccination 
  - Seizures with or without fever, occurring within 3 days of vaccination
• Acute, severe febrile illness
• Minor infection
• Family history of seizures 
• Very premature infants (born ≤28 weeks of gestation), particularly with a history of respiratory immaturity

Not indicated for use in adults 

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

Primary (basic) vaccination against diphtheria, tetanus and pertussis

Younger than 6 weeks

• Not established for use 

6 weeks and older

• IM: 1st, 2nd and 3rd dose: 0.5ml, given at intervals of 1 month with each dose given within the first 6 months

Booster doses (4^th and 5^th dose) following primary (basic) vaccination with either the DTaP vaccine or the DTPw (whole-cellular vaccine)

Between 15-19 months

• IM: 1^st booster (4^th dose): 0.5ml, 1 year after primary (basic) vaccination with DTaP or DTPw vaccine (at 15-19 months)

Between 4-6 years

• 2^nd booster (5^th dose): IM: 0.5ml

Diphtheria/ tetanus/ acellular pertussis should be injected intramuscularly in the deltoid region. Diphtheria/ tetanus/ acellular pertussis should under no circumstances be injected intravenously

Instructions for use/handling: The vaccine should be well shaken, in order to obtain a homogenous turbid suspension and inspected visually for any foreign particulate matter and/or variation of physical aspect prior to administration. In the event of either being observed, discard the vaccine

Pregnancy

• Not indicated for use in adults
• Safety in pregnancy has not been established. As DTaP is not intended for use in adults, adequate human data on use during pregnancy and adequate animal reproduction studies are not available

Breastfeeding

• Not indicated for use in adults 
• Safety in breastfeeding has not been established. As DTaP is not intended for use in adults, adequate human data on use during breastfeeding and adequate animal reproduction studies are not available

Fertility

• No information available

Renal Impairment

• Caution; no information available

Hepatic Impairment

• Caution; no information available

Elderly

• Not indicated for use in geriatric patients 

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Irritability
• Restlessness
• Abnormal crying
• Somnolence 
• Headache
• Fatigue
• Collapse or shock-like state (hypotonic-hyporesponsiveness episode)
• Seizures (with or without fever)

Respiratory Disorders 

• Cough
• Bronchitis
• Apnoea (in very premature infants - born ≤28 weeks of gestation)

Gastrointestinal Disorders 

• Diarrhoea 
• Vomiting

Endocrine and Metabolic Disorders 

• Appetite loss

Skin and Subcutaneous Tissue Disorders 

• Pruritus 
• Rash 
• Urticaria
• Injection site reactions
  - Redness
  - Local swelling (≤50mm)
  - Local swelling at the injection site (>50mm) 
  - Indurations
  - Diffuse swelling of the injected limb, sometimes involving the adjacent joint
  - Swelling of the entire injected limb
• Angioneurotic oedema

Immune, Blood and Lymphatic System Disorders 

• Lymphadenopathy
• Fever (≥38.0°C or ≥39.1°C)
• Thrombocytopenia
• Allergic reactions
  - Anaphylactic  and anaphylactoid reactions

Others

• Pain

No significant interactions (See additional prescribing points)

Some cases may require

• Respiratory monitoring (very premature infants born ≤28 weeks of gestation) 

Additional observations

• Anaphylaxis and syncope (15-30mins after administration) 

Immunocompromised persons

• Patients with an impaired immune response including patients receiving immunosuppressive therapy, or who have HIV infections, may have reduced antibody response to this vaccine
• Appropriate medical treatment, including adrenaline, should always be readily available in case of anaphylactic reactions following the administration of the vaccine. For this reason, the vaccinee should remain under medical supervision for 30 minutes after immunisation

Interactions

• DTaP can be administered simultaneously or at any temporal relationship with other paediatric vaccines
• Different injectable vaccines should always be administered at different injection sites

The diphtheria, tetanus, acellular pertussis vaccine (DTaP) induces a specific active immunity to diphtheria, tetanus and pertussis.

COMBINATION PREPARATIONS

Diphtheria/ Tetanus/ Acellular Pertussis (DTaP)

Injection 0.5ml

• Infanrix (GSK) originator