Imovax d.T. Adverse Reactions

In adults, the safety of Imovax d.T. was evaluated in a controlled, randomized, double-blind clinical trial with 252 participants aged 18 to 49 years. Participants received one dose of Imovax d.T. and simultaneously one dose of inactivated polio vaccine (IPV).
At the Td vaccine injection site, pain was the most common adverse reaction; most injection site reactions occurred within 3 days of vaccination. The most common systemic adverse reactions were headache, diarrhea, temperature ≥38°C and nausea/vomiting.
Other pediatric population: In adolescents, the safety of Imovax d.T. was evaluated in two studies where 1000 adolescents from 13 to 17 years of age received one dose of Imovax d.T. with or without concomitant Meningococcal C vaccine. The safety profile of Imovax d.T. in adolescents from 13 to 17 years of age was generally similar to that in adults. Headache, feeling of sickness, and redness and oedema at the injection site were very common in adolescents from 13 to 17 years of age.
In children, the safety of Imovax d.T. was evaluated in a controlled, randomized, open clinical trial where 151 children 6 to 9 years old received one dose of Imovax d.T. The safety profile of Imovax d.T. in children from 6 years through 9 years of age was generally similar to that in adults. Redness and induration at the injection site were very common in children from 6 to 9 years of age.
Tabulated list of adverse reactions: The adverse reactions are listed by MedDRA system organ class under headings of frequency using the following convention: Very common: (≥1/10); Common: (≥1/100, <1/10); Uncommon: (≥1/1,000, <1/100); Rare: (≥1/10,000, <1/1,000); Very rare: (<1/10,000); Not known: cannot be estimated from available data.
The following table lists the adverse reactions from the previously mentioned clinical studies and the adverse reactions that have been reported spontaneously by post-marketing surveillance of Imovax d.T. (See Table 2.)

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All these reactions have been observed more frequently in hyperimmunized individuals, especially in the case of too frequent booster vaccinations.
In adults previously vaccinated and with important delay since the last tetanus-diphtheria vaccination no increase of reactogenicity has been observed after a second dose of Td-IPV vaccine (containing the same content of diphtheria and tetanus antigens as Imovax d.T.) given one month after the first dose (see Pharmacology: Pharmacodynamics under Actions).
Possible side effects (i.e. adverse reactions reported with other vaccines containing one or more of the antigenic components of Imovax d.T. and not directly with Imovax d.T.): Brachial neuritis and Guillain-Barré syndrome have been reported after administration of tetanus toxoid-containing vaccines.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of medicinal products is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.