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Pharmacology: Pharmacodynamics: Anti-diphtheria and anti-tetanus antibody levels ≥0.01 IU/mL are considered as the minimum level providing some degree of protection, while antibody levels ≥0.1 IU/mL are considered protective.
The immune responses to Imovax d.T. were evaluated in clinical trials carried out in participants of different ages having different vaccination histories. The immune responses observed one-month after vaccination with Imovax d.T. are presented in the table as follows. (See Table 1.)
Click on icon to see table/diagram/imageImmunity is reinforced in the days (5 to 7 days) following the booster injection and is generally considered to last for 5 to 10 years.
Persistence of immune response in adults: Persistence of immune response following administration of Imovax d.T. in adults has not been investigated.
Following administration of Td-IPV (containing the same content of diphtheria and tetanus antigens as Imovax d.T.) as a booster in adults (18.5 to 57 years of age with 5 to 20 years since last tetanus-diphtheria-poliomyelitis booster, N=131), immune responses against tetanus and diphtheria have been shown to persist for 2 years post-vaccination with anti-tetanus antibody levels ≥0.1 IU/mL and ≥1 IU/mL (long-term protection) observed in 100% and 80.7% of participants respectively, and, anti-diphtheria antibody levels ≥0.1 IU/mL and ≥1 IU/mL observed in 94.7% and 49.1% of participants respectively.
Persistence of immune response in children: Persistence of immune response following administration of Imovax d.T. in children has not been investigated.
Following administration of Td-IPV (containing the same content of diphtheria and tetanus antigens as Imovax d.T.) as a booster in children from 6 years of age (N=128), immune responses against tetanus and diphtheria have been shown to persist for 5-7 years post-vaccination with anti-tetanus antibody levels ≥0.01 IU/mL and ≥0.1 IU/mL observed in 100% and 96.1% of participants respectively, and, anti-diphtheria antibody levels ≥0.01 IU/mL and ≥0.1 IU/mL observed in 98.4% and 63.3% of participants respectively.
Immune response after a 2nd dose in older adults: In adults (40 to 78 years) previously vaccinated and with important delay since last tetanus-diphtheria vaccination (28 to 33±11 years [range 11 to 60 years]) receiving 2 doses of Td-IPV vaccine (containing the same tetanus and diphtheria antigen content as Imovax d.T.), antibody levels ≥0.1 IU/mL were observed in 97.3% of participants one month after the first dose and 100% of participants one month after the second dose for tetanus, and in 80.5% of participants one month after the first dose and 93.7% of participants one month after the second dose for diphtheria.
Pharmacokinetics: No pharmacokinetic studies have been performed.
Toxicology: Preclinical safety data: Not documented.
