COVID-19 trials registries data warehouse

https://rpcec.sld.cu/en/trials/RPCEC00000314-En

Maria Toledo Romani

mariaeugenia@ipk.sld.cu

2020-05-22

Recruiting

nonRCT

Non-randomized

Parallel

Open label

single-center

Prevention

1. Male or female subject =19 years resident in the areas of intervention of Popular Councils of the Plaza and Centro Habana municipalities, of Havana2. Subject that gives the Informed Consent

1. Subject with a history of acute allergic processes. 2. Subject with a history of acute infectious disease at the time of vaccination or in the 7 days prior to the administration of the vaccine 3. Subject with a history of chronic diseases in the decompensation phase 4. Pregnant women-Subjects with known hypersensitivity to any component of the vaccine 5. Subjects with immunomodulatory treatment (immunostimulant or immunosuppressant)

2

Finlay Vaccine Institute (IFV)

19

100

Cuba

Healthy volunteers

N/A

115000

EIndicators: No. of cases (suspected; confirmed; serious; critical; deceased) Unit of Measure: Proportional variation. Measurement time: weekly (statistical weeks until the end of the epidemic)

| Declared number of arm (2.0) differs from found arms (3.0)

Not reported

[{"arm_notes": "1", "treatment_id": 781, "treatment_name": "Meningococcal vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]