COVID-19 trials registries data warehouse

https://rpcec.sld.cu/en/trials/RPCEC00000354-En

Mayra Garcia Carmenate

mayragc@infomed.sld.cu

2021-03-03

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

1. Subjects who give their informed consent to participate in the study in writing. 2. Subjects aged between 19 and 80 years. 3. Women of childbearing age who use contraceptive methods during the study and are willing to use them up to 3 months after the corresponding vaccination schedule has concluded.

1. Subjects with acute febrile or infectious disease in the 7 days prior to the administration of the vaccine or at the time of its application. 2. Subjects with diminished mental faculties for decision making. 3. Subjects with a history of hypersensitivity to thiomersal or to some of the components of the formulation. 4. Previous or current history of SARS-CoV-2 infection (questioning) 5. Application of vaccines containing tetanus toxoid in the last 3 months. 6. Subjects previously vaccinated against SARS-CoV-2. 7. Treatment with immunomodulators in the last 30 days, considering steroids (except topical and inhaled), cytostatics, interferon, immunoferon, transfer factor, Biomodulin T, any gamma globulin, Levamisole, Heberferon, thymosin) or other drugs with immunomodulatory action. In addition, those people who, due to their underlying disease, require immunomodulatory treatment during the development of the study. 8. Pregnancy, puerperium or lactation. 9. Subjects with tattoos in the deltoid region on both arms. 10. Decompensated chronic diseases that limit vaccination according to clinical criteria. 11. HIV subjects with detectable viral load, history of opportunistic infection or CD4 less than 200 copies. 12. Subjects with unstabilized malignant disease or who are receiving cytostatic treatment and / or radiotherapy during the time of the study or have been receiving it in the last three months.

3

Finlay Vaccine Institute (IFV)

19

80

Cuba

Healthy volunteers

N/A

44010

Virologically confirmed symptomatic infection of Covid-19. Measurement time: from 14 days after the last dose of the candidate until 3 months after this evaluation.

Phase 3

[{"arm_notes": "25 \u00b5g;2;Day0-28;IM", "treatment_id": 515, "treatment_name": "Finlay-fr-2 anti-sars-cov-2 vaccine", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "(25 \u00b5g;2;Day0-28)+booster(50 \u00b5g;1;Day56);IM", "treatment_id": 1519, "treatment_name": "Finlay-fr-1a anti-sars-cov-2 vaccine+finlay-fr-2 anti-sars-cov-2 vaccine", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]