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Pharmacology: No established correlates of protection to pertussis antigens are currently available. Although efficacy or effectiveness data of Boostagen are not available for adolescents and adults including pregnant women, non-inferiority of the immune response of Boostagen was demonstrated as per WHO recommendations (TRS 979, 2013) in adolescents for anti-PT and anti-FHA antibody titers measured by ELISA and for seroconversion rates in a comparative randomized controlled trial with a licensed Tdap vaccine evaluated in effectiveness studies. Seroconversion is defined as ≥ 4 folds increase of antibody titers at 28 days after vaccination as compared to baseline titers.
The seroconversion rates of anti-PT and anti-FHA antibody titers were statistically significantly higher in subjects vaccinated with Boostagen (respectively 97% and 83%) than in subjects vaccinated with the Tdap comparator vaccine, respectively 55% and 54%. Immunogenicity of tetanus and diphtheria toxoids was similar to the Tdap comparator vaccine.
