COVID-19 trials registries data warehouse

https://rpcec.sld.cu/en/trials/RPCEC00000384-En

Beatriz Paredes Moreno

bparedes@finlay.edu.cu

2021-07-23

Recruiting

RCT

Randomized

Single group assignment

Open label

single-center

Prevention

1) Subjects aged between 3 and 18 years. 2) Voluntariness expressed through informed consent to participate in the study: - Subjects aged 3-11 years: Informed consent of the father, mother or legal guardian. - Subjects aged 12-18 years: Informed Consent of the father, mother or legal guardian and Informed Assent of the adolescent. 3) General, regional and apparatus physical examination without alterations.

1) Subjects with acute febrile or infectious disease at the time of the vaccine application or in the 7 days prior to its administration. 2) Subjects meeting any of the following criteria: a) Previous or current history of SARS-CoV 2 infection. b) Being declared in the contact or suspect category at the time of inclusion. 3) Subjects with a history of hypersensitivity to Thimerosal or any of the components of the formulations. 4) Subjects with a history of having been immunized with a vaccine against SARS-CoV 2. 5) Subjects with a history of having received a vaccine from the Cuban immunization scheme, in a period of less than 30 days prior to the administration of the investigational product . 6) Use of any investigational product in the 30 days prior to immunization. 7) Application of vaccines containing tetanus toxoid in the last 3 months. 8) Subjects with a history of major congenital malformations (defects that have an important functional compromise for the individual's life, have medical consequences and require early attention, sometimes urgently). 9) Primary or secondary immune system disease. 10) History of neoplastic disease. 11) History of severe allergic reactions. 12) Treatment with immunomodulators in the last 30 days (eg steroids (except topical and inhaled), Interferon, Immunoferon, Nasalferon, Transfer Factor, monoclonal antibody, Biomodulin T, any ganmaglobulin, Heberferon, Thymosin, Levamisole). 13) Subjects with a history of Convulsive Disease. 14) History of treatment with blood products such as blood cell, plasma, whole blood or platelet concentrate transfusions in the last 4 months. 15) Splenectomy or splenic dysfunction. 16) Pregnancy or lactation (a pregnancy test will be carried out before inclusion and administration of each dose to all girls and adolescents who menstruate). 17) Subjects with tattoos in the deltoid region of both arms. 18) Subjects with a history of HIV1 + 2 antibodies, hepatitis C antibodies, hepatitis B virus surface antigen, or VDRL serology. 19) History of psychoactive substance use in the last 6 months.

1

Instituto Finlay de Vacunas (IFV)

3

18

Cuba

Healthy volunteers

N/A

425

Serious Adverse Events-SAE (It will measure as: -Occurrence of the SAE (Yes; No); - Duration (Time from start date until end date of event); -Description of the event; Result (Recovered; Recovered with squeals; Persists; Death; Unknown); - Causality (Causal association consistent with vaccination; Undetermined; Inconsistent causal association with vaccination; not classifiable). Measurement time: daily for 28 days after each dose.

Phase 2

[{"arm_notes": "Finlay FR 2 25 \u00b5g+Finlay FR 1A 50 \u00b5g;2+1;days 0-28 + day 56;IM (third dose)", "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"}]