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Clinical Trials associated with COVID-19 mRNA vaccine (Fiocruz)An Observer-blind, Cohort Randomized, Exploratory Phase 3 Study to Evaluate the Safety and Immunogenicity of Recombinant Covid-19 Vaccine (AstraZeneca/Fiocruz), mRNA Covid-19 (Comirnaty, Pfizer/Wyeth) Vaccine and Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine (SCB-2019-Clover) as 4th Dose in Individuals Primed/ Boosted With Various Regimens
This is an exploratory phase 3, cohort randomized, observer-blind, multi-center study to evaluate the safety and immunogenicity of a 4th dose of various SARS-CoV-2 vaccines. There will be 04 study cohorts, that have previously received 03 doses of the indicated vaccine (s), divided into 10 groups; and each one of the 10 study groups will receive the 4th dose. This exploratory study will enroll up to 360 participants in 4 cohorts and a total of 10 groups: Cohort A (N=90), Cohort B (N= 90), Cohort C (N=150) and Cohort D (N=30). In cohorts A-C participants will be randomized 1:1:1 to three different 4th dose regimens. The number of proposed participants will provide a reasonable accurate descriptive summary of the safety and immunogenicity of the tested vaccination regimens.
Phase 4, randomized, controlled, single-blind study to assess the immunogenicity and safety of a third dose of heterologous booster with recombinant covid-19 vaccine (AstraZeneca/Fiocruz), covid-19 mRNA vaccine (Pfizer/Wyeth) or vaccine recombinant covid-19 (Janssen) in subjects previously vaccinated against Covid-19 with two doses of Sinovac/Butantan compared to a third homologous booster dose of adsorbed inactivated covid-19 vaccine (Sinovac/Butantan) in adults
Start Date01 Aug 2021 |
Sponsor / Collaborator- |
100 Clinical Results associated with COVID-19 mRNA vaccine (Fiocruz)
100 Translational Medicine associated with COVID-19 mRNA vaccine (Fiocruz)
100 Patents (Medical) associated with COVID-19 mRNA vaccine (Fiocruz)
100 Deals associated with COVID-19 mRNA vaccine (Fiocruz)