If any of the following events occur in temporal relation to receipt of whole-cell DTP or acellular DTP vaccine, the decision to give subsequent doses of vaccine containing the pertussis component should be carefully considered. There may be circumstances, such as high incidence of pertussis, in which the potential benefits outweigh possible risks, particularly since these events have not been proven to cause permanent sequelae.^1,18 The following events were previously considered contraindications and are now considered precautions by the ACIP:

· Persistent, inconsolable crying lasting ≥ 3 hours, occurring within 48 hours

· Convulsions with or without fever occurring within 3 days

In the Italian efficacy trial, the incidence of temperature ≥ 104° F, crying for 3 hours or more and seizures within 48 hours of vaccination was less than that following administration of whole-cell DTP vaccine manufactured by Connaught Laboratories, Inc. No hypotonic-hyporesponsive episodes were reported after administration of Infanrix in this trial¹³ (see ADVERSE EVENTS - Table 7).

A committee of the Institute of Medicine (IOM) has concluded that evidence is consistent with a causal relationship between whole-cell DTP vaccine and acute neurologic illness, and under special circumstances, between whole-cell DTP vaccine and chronic neurologic disease in the context of the National Childhood Encephalopathy Study (NCES) report.^21,22 However, the IOM committee concluded that the evidence was insufficient to indicate whether or not whole-cell DTP vaccine increased the overall risk of chronic neurologic disease.²² While acute encephalopathy and permanent neurologic damage have not been reported in temporal association after administration of Infanrix (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed), the data at this time are insufficient to rule this out.

The ACIP and the AAP recognize certain circumstances in which children with stable central nervous system disorders, such as well-controlled seizures or satisfactorily explained single seizures, may receive pertussis vaccine. The decision to administer a pertussis-containing vaccine to such children must be made by the physician on an individual basis, with consideration of all relevant factors, and assessment of potential risks and benefits for that individual. ACIP and AAP have issued guidelines for such children.^1,18,20 The parent or guardian should be advised of the potential increased risk involved (see Information for the Patient). Studies suggest that, when given whole-cell DTP vaccine, infants and children with a history of convulsions in first-degree family members (i.e., siblings and parents) have a 2.4-fold increased risk for neurologic events compared with those without such histories.²³ However, the ACIP has concluded that a history of convulsions or other central nervous system disorders in parents or siblings is not a contraindication to pertussis vaccine and that children with such family histories should receive pertussis vaccine according to the recommended schedule.^1,17,18,24 For children at higher risk for seizures than the general population, it may be prudent to extend the ACIP and AAP recommendations for whole-cell DTP vaccine to Infanrix: that acetaminophen be administered at age-appropriate doses at the time of DTP vaccination and every 4 to 6 hours for 24 hours.^1,18,20 Infanrix should not be given to infants or children with any coagulation disorder, including thrombocytopenia, that would contraindicate intramuscular injection unless the potential benefit clearly outweighs the risk of administration.

Although a moderate or severe febrile illness is sufficient reason to postpone vaccination, minor illnesses such as mild upper respiratory infections with or without low-grade fever are not contraindications.^1,18 Before the injection of any biological, the physician should take all reasonable precautions to prevent allergic or other adverse reactions, including understanding the use of the biological concerned, and the nature of the side effects and adverse reactions that may follow its use. Prior to immunization, the patient's medical history should be reviewed. The physician should review the patient's immunization history for possible vaccine sensitivity, previous vaccination-related adverse reactions and occurrence of any adverse-event-related symptoms and/or signs, in order to determine the existence of any contraindication to immunization with Infanrix and to allow an assessment of benefits and risks. Epinephrine injection (1:1000) and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur.

A separate sterile syringe and needle or a sterile disposable unit should be used for each individual patient to prevent transmission of hepatitis or other infectious agents from one person to another. Needles should be disposed of properly and should not be recapped.

Special care should be taken to prevent injection into a blood vessel.

Infanrix (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) is not contraindicated for use in individuals with HIV infection.^17,25 As with any vaccine, if administered to immunosuppressed persons, including individuals receiving immunosuppressive therapy, the expected immune response may not be obtained.²⁵

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