SOBERANA PEDIATRIA

Phase 1

• Conditions: COVID-19; SARS-CoV2; Disease Prevention; Coronavirus Infections; SARS Virus; Coronaviridae Infections; Betacoronavirus

• Registration Number: RPCEC00000374
• Lead Sponsor: Finlay Vaccine Institute (IFV)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-10
• Results First Posted: 2022-01-31
• Study Completion: 2022-02-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

1. Subjects aged between 3 and 18 years.
2. Voluntariness expressed through informed consent to participate in the study:
- Subjects 3-11 years old: Informed consent of parents or legal guardians
- Subjects aged 12-18 years: Informed Consent of the parents or legal guardians and Informed Assent of the adolescent.
3. Weight-height nutritional assessment between the 10th and 90th percentile (for subjects between 3 and 9 years of age) or the Body Mass Index between the 10th and 90th percentile for subjects between 10 and 18 years of age), according to the cut-off points for the Cuban pediatric population.
4. General, regional and apparatus physical examination without alterations.
5. Laboratory results within or outside the range of reference values ??but not clinically significant (For the subjects to be included in phase I).

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 that meet any of the following criteria:
a) Previous or current history of SARS-CoV 2 infection.
b) SARS-CoV 2 PCR positive.
c) Be declared in the category of contact or suspect at the time of inclusion.
3. Subjects with a history of hypersensitivity to Thiomersal or any of the components of the formulations.
4. Subjects with a history of having been immunized with a SARS-CoV 2 vaccine.
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 product under investigation.
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. History of chronic diseases.
9. Subjects with a history of major congenital malformations (defects that have a significant functional compromise for the individual's life, have medical consequences and require early, sometimes urgent, care).
10. Primary or secondary immune system disease.
11. History of neoplastic disease.
12. History of severe allergic reactions.
13. 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).
14. Subjects with a history of Convulsive Disease.
15. History of treatment with blood products such as blood cell, plasma, whole blood or platelet concentrate transfusions in the last 4 months.
16. Splenectomy or splenic dysfunction.
17. Child with a minor or mentally disabled mother or father.
18. Pregnancy or lactation (a pregnancy test will be carried out before inclusion and administration of each dose to all girls and adolescents who menstruate).
19. Subjects with tattoos in the deltoid region of both arms.
20. Subjects with a history or positive results for: antibodies against HIV1 + 2, antibodies against hepatitis C, surface antigen of the hepatitis B virus or VDRL serology.
21. History of psychoactive substance use in the last 6 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified