Inicio | SOBERANA PEDIATRIA
28 Agosto 2024 - 9:56am por FINLAY28 Agosto 2024 - 11:09am por FINLAY
Cambios a Primary outcome(s)
 
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.
 
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 II:
 
Phase II:
-
Concentration of specific anti-RBD IgG antibodies (Percentage of subjects with seroconversion 4-fold to pre-vaccination). Measurement time: Day 0, 42 and 70
+
Concentration of specific anti-RBD IgG antibodies. Measurement time: Day 0, 42, 70, period of time between 5 and 12 months after the completion of the heterologous regimen and 14 days after the booster dose
Cambios a Key secondary outcomes
 
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 .
 
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 (Percentage of subjects with seroconversion 4-fold to pre-vaccination). Measurement time: Day 0, 42 and 70.
 
3) Concentration of specific anti-RBD IgG antibodies (Percentage of subjects with seroconversion 4-fold to pre-vaccination). Measurement time: Day 0, 42 and 70.
-
4) Neutralizing antibody titer: Measurement time: Day 42 and 70.
+
4) Neutralizing antibody titer: Measurement time: Day 42, 70, period of time between 5 and 12 months after the completion of the heterologous regimen and 14 days after the booster dose.
-
5) % ACE2-RBD inhibition: Measurement time: Day 0, 42 and 70.
+
5) % ACE2-RBD inhibition: Measurement time: Day 0, 42, 70, period of time between 5 and 12 months after the completion of the heterologous regimen and 14 days after the booster dose.
 
Phase II:
 
Phase II:
 
1) 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.
 
1) 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.
 
2) 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 3 days after each dose.
 
2) 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 3 days after each dose.
 
3) 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) 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 .
-
4) Neutralizing antibody titer: Measurement time: Day 42 and 70.
+
4) Neutralizing antibody titer: Measurement time: Day 42, 70, period of time between 5 and 12 months after the completion of the heterologous regimen and 14 days after the booster dose.
-
5) % ACE2-RBD inhibition: Measurement time: Day 0, 42 and 70.
+
5) % ACE2-RBD inhibition: Measurement time: Day 0, 42, 70, period of time between 5 and 12 months after the completion of the heterologous regimen and 14 days after the booster dose.
Cambios a Intervention(s)
 
FINLAY-FR-2: 25 µg of RBD-TT, by intramuscular route, 0.5 mL, in scheme 0 - 28 days.
 
FINLAY-FR-2: 25 µg of RBD-TT, by intramuscular route, 0.5 mL, in scheme 0 - 28 days.
 
FINLAY-FR-1A: 50 µg of d-RBD + Aluminum Hydroxide Gel, by intramuscular route, 0.5 mL as dose booster 56 days.
 
FINLAY-FR-1A: 50 µg of d-RBD + Aluminum Hydroxide Gel, by intramuscular route, 0.5 mL as dose booster 56 days.
  +
FINLAY-FR-1A: 50 µg of d-RBD + Aluminum Hydroxide Gel, by intramuscular route, 0.5 mL as dose booster at least 6 months after the completion of the heterologous schedule.
 
 
Cambios a Inclusion criteria
 
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.
 
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.
 
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).
+
5. Laboratory results within or outside the range of reference values ​​but not clinically significant (For the subjects to be included in phase I).
  +
  +
Inclusion criteria to be considered for the evaluation of the duration of the response and the safety and immunogenicity of the booster dose:
  +
1. Subjects included in the SOBERANA PEDIATRIA trial with a completed heterologous schedule and with immunological results at t70.
  +
2. Voluntary consent expressed through informed consent to participate in the study for the new stages:
  +
a) Subjects aged 3-11 years: Informed Consent from parents or legal guardians
  +
b) Subjects aged 12-18 years: Informed Consent from parents or legal guardians and Informed Assent from the adolescent
Cambios a Exclusion criteria
 
19. Subjects with tattoos in the deltoid region of both arms.
 
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.
 
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.
+
21. History of psychoactive substance use in the last 6 months.
  +
  +
Exclusion criteria to be considered for the evaluation of the duration of the response and the safety and immunogenicity of the booster dose:
  +
1. Subject who has caused interruption in the SOBERANA PEDIATRIA study
  +
2. Subjects with a history of having received any vaccine against SARS-CoV 2 in addition to the heterologous schedule applied in the clinical trial. 3. Subject with a positive SARS-CoV-2 antigen test at the time prior to the administration of the booster dose or convalescent (diagnosis made by PCR)
  +
4. Subjects with febrile or acute infectious disease at the time of vaccine application or in the 7 days prior to its administration
  +
5. Subjects with a history of having received any vaccine from the Cuban immunization schedule, in a period of less than 30 days prior to the administration of the booster dose
  +
6. Use of any investigational product in the 30 days prior to the administration of the booster dose
  +
7. Treatment with immunomodulators in the last 30 days (e.g. steroids (except topical and inhaled), Interferon, Immunoferon, Nasalferon, Transfer Factor, monoclonal antibody, Biomodulin T, any ganmaglobulin, Heberferon, Thymosin, Levamisole). (3rd stage)
  +
8. History of treatment with blood products such as transfusions of red blood cells, plasma, whole blood or platelet concentrate in the 4 months prior to the administration of the booster dose
  +
9. Pregnancy or breastfeeding at the time of the booster vaccine application
  +
10. Subjects with tattoos in the deltoid region of both arms.
  +
11. History of consumption of psychoactive substances in the last 6 months.
Cambios a Study completion date
-
2021-10-07T00:00:00
+
2022-07-06T00:00:00
Cambios a Date of available results
-
2022-02-20T00:00:00
+
2023-01-15T00:00:00
Cambios a Date of first publication
-
2022-01-31T00:00:00
+
2023-01-31T00:00:00
Cambios a Record Verification Date
-
2022/04/01
+
2024/08/28
Cambios a Next update date
-
2023/04/01
+
2025/08/28
Revisión de 28 Agosto 2024 - 11:09am