COVID-19 COVID-19 SARS-CoV2
Conditions
Interventions
Experimental Group: FINLAY-FR-2, 25 µg of RBD-TT / alumina, Intramuscular (IM), 0.5 mL, 0 - 28 days. Presentation: Vial with single dose / Vial with multidose of 10 doses + FINLAY-FR-1A, 50 µg of d-RB
Immunogenicity, Vaccine
Immunotherapy, Active
Vaccination
Injections, Intramuscular
Sponsors
Instituto Finlay de Vacunas (IFV)
No procede
Eligibility
Sex/Gender
All
Age
3 Years to 18 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Solicited Local and systemic Adverse Events (AE) (They will measure as: -Occurrence of the AE (Yes, No), Duration (Time from start date until end date of event), -Intensity of the AE (mild, moderate, severe), -Severe (Serious, not serious), -Result (Recovered, Recovered with sequelae, Persists, Death, Unknown), -Causation (causal association consistent with vaccination, Indeterminate, causal association inconsistent with vaccination, not classifiable)). Measurement time: daily for 7 days after each dose. 2) Unsolicited Adverse Events (AE) (They will measure as: Description of the AE (name of the event), Duration (Time from start date until end date of event), -Intensity of the AE (mild, moderate, severe), -Severe (Serious, not serious) , -Result (Recovered, Recovered with sequelae, Persists, Death, Unknown), -Causality (causal association consistent with vaccination, Undetermined, causal association inconsistent with vaccination, not classifiable)). Measurement time: daily for 28 days after each dose . 3) Concentration of specific anti-RBD IgG antibodies. Measurement time: Day 70. 4) Neutralizing antibody titer: Measurement time: Day 70. 5) % ACE2-RBD inhibition: Measurement time: Day 70. | — |
Countries
Cuba
Contacts
Public ContactBeatriz Paredes Moreno
Finlay Vaccine Institute
Outcome results
None listed