The primary objectives of this study are: (i) Immediate versus 12 week deferral of first dose administration, and also (ii) One dose only, versus two doses to be given 4 weeks apart. They will be randomized as part of a 2x2 factorial design to one of four groups:
#Tico trial trial#
Participants from the ACTIV-3/TICO clinical trial must still be blinded and be within 28 to 90 days after their initial TICO randomization. Condition or diseaseīiological: Moderna mRNA-1273 COVID-19 vaccine Biological: Pfizer BNT162b2 COVID-19 vaccine
Participants will remain blinded to the interventions received in the ACTIV-3/TICO study, however allocation to the timing of vaccination and to one or two vaccinations in this (VATICO) study is not blinded. The study's objective is to evaluate if the vaccine is best administered early or deferred after recovery, and whether one injection provides comparable immune response to a two injection course of vaccination. The choice is individual, although participants vaccinated twice should receive the same type of vaccine when receiving two injections. No "dummy/placebo" vaccine will be used.Ĭhoice of Moderna or Pfizer vaccine is determined based on availability at the site. In this Phase 4, open-label trial, participants of the ACTIV-3/TICO clinical trial (NCT04501978) at selected study sites who receive certain pre-specified, blinded investigational agents or placebo as part of that trial and who have since achieved sustained recovery from COVID-19 and meet certain criteria, including not having received a COVID-19 vaccination since enrollment, will be randomized to one of four groups to receive the Moderna mRNA-1273 or the Pfizer BNT162b2 vaccine (mRNA vaccines). Why Should I Register and Submit Results?.
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