Clinical Trial Adverse Drug 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 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-POLIO has been evaluated in a total of 1,636 participants who received a single dose of ADACEL-POLIO in 7 clinical trials (644 children 3 to 7 years of age, 992 adolescents and adults 11 to 60 years of age). Pain was the most common injection site reaction in all age groups. Most injection site reactions occurred within 3 days following vaccination. The most frequent systemic reaction was headache in adolescents and adults and tiredness in children. These reactions were usually transient and of mild to moderate intensity.
Table 2 presents the frequencies of the solicited injection site and systemic adverse events reported in 3 UK clinical trials in which children previously primed with 3 doses of PEDIACEL [Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine and Haemophilus b Conjugate Vaccine (Tetanus Protein - Conjugate)] or a whole-cell pertussis combination vaccine, received a pre-school booster dose of ADACEL-POLIO at 3 to 5 years of age. In addition, adverse events of irritability (7.3%), injection site bruising (3.3%), injection site pruritus (2.7%) and dermatitis (1.3%) were reported within 7 days of vaccination in two of these studies.
In clinical trials in children ADACEL-POLIO showed a comparable safety profile to that of ADACEL [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed]. Therefore, the safety of ADACEL-POLIO, in particular for use as a 4 to 6 years-old booster dose is further supported by a study conducted with ADACEL in 298 children.
The frequency of the solicited injection site and systemic adverse events reported in a Canadian clinical trial in adolescents and adults are also presented in Table 2. (See Table 2.)
Click on icon to see table/diagram/image
Post-Market Adverse Drug Reactions: The following additional adverse events have been spontaneously reported during the post-marketing use of ADACEL-POLIO. Because these events are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.
Blood and Lymphatic Disorders: Lymphadenopathy.
Immune System Disorders: Anaphylactic reactions, such as urticaria, face edema and dyspnea.
Nervous System Disorders: Convulsions, vasovagal syncope, Guillain-Barré syndrome, facial palsy, myelitis, brachial neuritis, transient paresthesia/ hypoesthesia of vaccinated limb, dizziness.
Musculoskeletal and Connective Tissue Disorders: Pain in vaccinated limb.
Gastrointestinal Disorders: Abdominal pain.
General Disorders and Administration Site Conditions: Extensive limb swelling, which may extend from the injection site beyond one or both joints and is frequently associated with erythema, and sometimes with blisters, has been reported following administration of ADACEL-POLIO. The majority of these reactions appeared within 48 hours of vaccination and spontaneously resolved over an average of 4 days without sequelae. The risk appears to be dependent on the number of prior doses of d/DTaP vaccine, with a greater risk following the 4th and 5th doses.
Malaise, pallor, injection site induration.