Boostrix Polio Adverse Reactions

Summary of the safety profile: The safety profile presented in Table 4 is based on data from clinical trials where Boostrix Polio was administered to 908 children (from 4 to 8 years of age) and 955 adults, adolescents and children (from 10 to 93 years of age).
The most common events occurring after Boostrix Polio administration in both groups were local injection site reactions (pain, redness and swelling) reported by 31.3-82.3% of subjects overall. These usually had their onset within the first 48 hours after vaccination. All resolved without sequelae.
Tabulated list of adverse reactions: Adverse reactions reported are listed according to the following frequency: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1000 to <1/100); Rare (≥1/10,000 to <1/1000); Very rare (<1/10,000).
Clinical trials: (See Table 4.)

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Coadministration with MMR/V vaccines in children aged 3-6 years: Boostrix Polio was coadministered with MMR/V vaccines in 2 clinical studies with 406 children aged 3-6 years. In these studies, upper respiratory tract infection and rash were commonly reported. Fever, irritability, fatigue, loss of appetite and gastrointestinal disorders (including diarrhoea and vomiting) were reported with a higher frequency (very common) when compared to Table 4 while all other adverse reactions occurred at the same or lower frequency. Adverse reactions additionally reported during clinical studies with Boostrix (dTpa component of Boostrix Polio), administered to 839 children (from 4 to 8 years of age) and 1931 adults, adolescents and children (from 10 to 76 years of age), are listed in Table 5. (See Table 5.)

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Reactogenicity after repeat dose: Data suggest that in subjects primed with DTP in childhood a second booster dose might give an increase of local reactogenicity.
Subjects aged 15 years onwards without recent vaccination for diphtheria, tetanus, pertussis and poliomyelitis, who received a dose of Boostrix Polio or another reduced-antigen content vaccine, followed by an additional dose of Boostrix Polio 10 years after, showed no increased reactogenicity after this second dose compared to the first one.
Post-marketing surveillance: Because these events were reported spontaneously, it is not possible to reliably estimate their frequency. (See Table 6.)

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Following administration of tetanus toxoid containing vaccines, there have been very rare reports of adverse reactions on the central or peripheral nervous systems, including ascending paralysis or even respiratory paralysis (e.g. Guillain-Barré syndrome).