Adacel/Adacel Polio Adverse Reactions

Adacel: Summary of the safety profile: In clinical trials ADACEL was given to a total of 4,546 persons, including 298 children (4 to 6 years), 1,313 adolescents (11 to 17 years) and 2,935 adults (18 to 64 years). Most commonly reported reactions following vaccination included local reactions at the injection site (pain, redness and swelling) that occurred in 21% - 78% of the vaccinees, headache and tiredness that occurred in 16% - 44% of vaccinees. These signs and symptoms usually were mild in intensity and occurred within 48 hours following vaccination. They all resolved without sequelae.
Safety analysis was conducted in 1,042 healthy adolescent males and females aged 10 to 17 years during a clinical trial. They received quadrivalent human papillomavirus types 6/11/16/18 vaccine (Gardasil) concurrently with a dose of ADACEL and a dose of quadrivalent meningococcal conjugate vaccine serogroup A, C, Y and W135. The safety profiles were similar in both concomitant and non-concomitant groups. Higher frequencies of swelling at the Gardasil injection site, bruising and pain at ADACEL injection sites were observed in the concomitant administration group. The differences observed between concomitant and non-concomitant groups were less than 7% and in a majority of subjects the adverse events were reported as mild to moderate in intensity.
Tabulated list of adverse reactions: Adverse reactions are ranked under headings of frequency using the following convention: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known cannot be estimated from the available data.
Table 6 presents adverse reactions observed in clinical trials and also includes additional adverse events which have been spontaneously reported during the post-marketing use of ADACEL worldwide. Because post-marketing adverse events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Therefore, the frequency category "Not known" is assigned to these adverse events. (See Table 6.)

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Description of selected adverse reactions: General Disorders and Administration Site Conditions: Large injection site reactions (>50 mm), including extensive limb swelling from the injection site beyond one or both joints occur after administration of ADACEL in adolescents and adults. These reactions usually start within 24 - 72 hours after vaccination, may be associated with erythema, warmth, tenderness or pain at the injection site and resolve spontaneously within 3 - 5 days.
Paediatric population: The safety profile of ADACEL as presented in Table 6 includes data from a clinical trial in 298 children 4 to 6 years of age who had previously received a total of 4 doses, including primary immunization, with DTaP-IPV combined with Hib, at approximately 2, 4, 6 and 18 months of age. In this clinical study, the most common adverse events reported within 14 days post vaccination were pain at the injection site (in 39.6% of subjects) and tiredness (in 31.5% of subjects).
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Adacel Polio: 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 7 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 7. (See Table 7.)

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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-Barre 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.