BACKGROUND: In France, the only vaccines available for use as a pertussis booster in adults are combined vaccines containing adsorbed tetanus, diphtheria (adult formulation), acellular pertussis and inactivated poliovirus (Tdap-IPV). Adults may require a pertussis booster relatively soon after having received vaccines containing tetanus-diptheria antigens (Td) (occupational or familial circumstances such as new job, childbirth in recent past or future), although the safety of Tdap-IPV when administered soon after vaccination with Td is undocumented. METHODS: In this randomized, double-blind, multi-centre study, we assessed the safety of Tdap-IPV administered one month after vaccination with tetanus, diphtheria (adult formulation), inactivated poliovirus vaccination (Td-IPV) in healthy adults vaccinated according to the French vaccination calendar (seven tetanus-diphtheria vaccinations by age 18 years). Subjects received either Td-IPV (n = 249) or placebo (n = 251) followed 1 month later by Tdap-IPV. Any adverse events (AEs) were recorded. RESULTS: The safety of Tdap-IPV was similar when Tdap-IPV vaccine was administered one month after either Td-IPV or placebo: at seven days, 85.1% versus 93.4% subjects reported at least one reaction at the injection site, mainly pain (82.6% versus 92.1%); 40.5% versus 45.0%, at least one systemic AE (mainly headache: 26.4% versus 26.0%); fever concerned 1.7% of both groups. No serious vaccine-related AEs were reported. Both safety profiles corresponded to documented product characteristics. CONCLUSIONS:Tdap-IPV may be administered to adults one month after Td-IPV without exacerbating post-vaccination side-effects.
RCT Entities:
BACKGROUND: In France, the only vaccines available for use as a pertussis booster in adults are combined vaccines containing adsorbed tetanus, diphtheria (adult formulation), acellular pertussis and inactivated poliovirus (Tdap-IPV). Adults may require a pertussis booster relatively soon after having received vaccines containing tetanus-diptheria antigens (Td) (occupational or familial circumstances such as new job, childbirth in recent past or future), although the safety of Tdap-IPV when administered soon after vaccination with Td is undocumented. METHODS: In this randomized, double-blind, multi-centre study, we assessed the safety of Tdap-IPV administered one month after vaccination with tetanus, diphtheria (adult formulation), inactivated poliovirus vaccination (Td-IPV) in healthy adults vaccinated according to the French vaccination calendar (seven tetanus-diphtheria vaccinations by age 18 years). Subjects received either Td-IPV (n = 249) or placebo (n = 251) followed 1 month later by Tdap-IPV. Any adverse events (AEs) were recorded. RESULTS: The safety of Tdap-IPV was similar when Tdap-IPV vaccine was administered one month after either Td-IPV or placebo: at seven days, 85.1% versus 93.4% subjects reported at least one reaction at the injection site, mainly pain (82.6% versus 92.1%); 40.5% versus 45.0%, at least one systemic AE (mainly headache: 26.4% versus 26.0%); fever concerned 1.7% of both groups. No serious vaccine-related AEs were reported. Both safety profiles corresponded to documented product characteristics. CONCLUSIONS:Tdap-IPV may be administered to adults one month after Td-IPV without exacerbating post-vaccination side-effects.
Authors: Jennifer L Liang; Tejpratap Tiwari; Pedro Moro; Nancy E Messonnier; Arthur Reingold; Mark Sawyer; Thomas A Clark Journal: MMWR Recomm Rep Date: 2018-04-27