NCT05052307 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Goulart Rosa R, Spinardi J, Allen KE, Manfio J, de Araujo CLP, Cohen M, Robinson CC, Sganzerla D, Ferreira D, de Souza EM, de Oliveira JC, Gradia DF, Brandalize APC, Kucharski GA, Pedrotti F, Rodrigues CO, Kyaw MH, Castillo GDCM, Srivastava A, McLaughlin JM, Falavigna M
BNT162b2 against COVID-19 in Brazil using a test-negative design: Study protocol and statistical analysis plan. PLoS One. 2022 Oct 20;17(10):e0276384. doi: 10.1371/journal.pone.0276384. eCollection 2022.
Rosa RG, Falavigna M, Manfio JL, de Araujo CLP, Cohen M, do Valle Barbosa GRG, de Souza AP, Romeiro Silva FK, Sganzerla D, da Silva MMD, Ferreira D, de Oliveira Rodrigues C, de Souza EM, de Oliveira JC, Gradia DF, Brandalize APC, Royer CA, Luiz RM, Kucharski GA, Pedrotti F, Valluri SR, Srivastava A, Juliao VW, Melone OC, Allen KE, Kyaw MH, Spinardi J, Del Carmen Morales Castillo G, McLaughlin JM; Toledo BNT16b2 Study Group Investigators
BNT162b2 mRNA COVID-19 against symptomatic Omicron infection following a mass vaccination campaign in southern Brazil: A prospective test-negative design study. Vaccine. 2023 Aug 23;41(37):5461-5468. doi: 10.1016/j.vaccine.2023.07.038. Epub 2023 Jul 26.

Effectiveness of Pfizer-BioNTech BNT162b2 mRNA COVID-19 Vaccine on Symptomatic SARS-CoV-2 Infection and COVID-19-related Hospitalizations, Mortality, and Long-term Consequences in Brazil: a Real-world Evidence Study

Details for clinical trial NCT05052307

Clinical trial NCT05052307 - References