Boostrix Polio Adverse Reactions

Clinical Trials Data: The safety profile presented in Table 3 is based on data from clinical trials where Boostrix Polio was administered to 908 children (from 4 to 9 years of age) and 955 adults, adolescents and children (above 10 years of age).
The most common events occurring after vaccine administration in both groups were local injection site reactions (pain, redness and swelling) reported by 31.3 - 82.3% of subjects overall. These had their onset within the first day after vaccination. All resolved without sequelae.
Adverse reactions reported are listed according to the following frequency: Very common (≥1/10); common (≥1/100 and <1/10); uncommon (≥1/1,000 and <1/100); rare (≥1/10,000 and <1/1000); very rare (<1/10,000). (See Table 3.)

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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 3 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 9 years of age) and 1,931 adults, adolescents and children (above 10 years of age), are listed in Table 4: (See Table 4.)

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Reactogenicity after repeat dose of Boostrix Polio or Boostrix: Subjects fully primed with 4 doses of DTPa followed by Boostrix Polio at around 4-8 years of age show no increased reactogenicity after the second Boostrix Polio dose administered 5 years later.
Subjects aged 15 years onwards without recent vaccination for diphtheria, tetanus, pertussis and polio, 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.
Subjects fully primed with 4 doses of DTPw followed by a Boostrix dose around 10 years of age show an increase of local reactogenicity after an additional Boostrix dose administered 10 years later.
Post-Marketing Data: (See Table 5.)

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