Comparing two revisions:
28 August 2024 - 9:56am by FINLAY | 28 August 2024 - 11:09am by FINLAY | ||
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Changes to 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.
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Phase II:
| Phase II:
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- | 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 |
Changes to 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 .
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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.
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- | 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.
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- | 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.
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Phase II:
| Phase II:
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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.
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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.
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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 .
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- | 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.
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- | 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. |
Changes to 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.
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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.
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+ | 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.
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Changes to 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.
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4. General, regional and apparatus physical examination without alterations.
| 4. General, regional and apparatus physical examination without alterations.
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- | 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).
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+ | |||
+ | Inclusion criteria to be considered for the evaluation of the duration of the response and the safety and immunogenicity of the booster dose:
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+ | 1. Subjects included in the SOBERANA PEDIATRIA trial with a completed heterologous schedule and with immunological results at t70.
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+ | 2. Voluntary consent expressed through informed consent to participate in the study for the new stages:
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+ | a) Subjects aged 3-11 years: Informed Consent from parents or legal guardians
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+ | b) Subjects aged 12-18 years: Informed Consent from parents or legal guardians and Informed Assent from the adolescent | ||
Changes to Exclusion criteria | |||
19. Subjects with tattoos in the deltoid region of both arms.
| 19. Subjects with tattoos in the deltoid region of both arms.
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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.
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- | 21. History of psychoactive substance use in the last 6 months. | + | 21. History of psychoactive substance use in the last 6 months.
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+ | |||
+ | Exclusion criteria to be considered for the evaluation of the duration of the response and the safety and immunogenicity of the booster dose:
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+ | 1. Subject who has caused interruption in the SOBERANA PEDIATRIA study
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+ | 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)
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+ | 4. Subjects with febrile or acute infectious disease at the time of vaccine application or in the 7 days prior to its administration
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+ | 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
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+ | 6. Use of any investigational product in the 30 days prior to the administration of the booster dose
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+ | 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)
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+ | 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
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+ | 9. Pregnancy or breastfeeding at the time of the booster vaccine application
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+ | 10. Subjects with tattoos in the deltoid region of both arms.
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+ | 11. History of consumption of psychoactive substances in the last 6 months. | ||
Changes to Study completion date | |||
- | 2021-10-07T00:00:00 | + | 2022-07-06T00:00:00 |
Changes to Date of available results | |||
- | 2022-02-20T00:00:00 | + | 2023-01-15T00:00:00 |
Changes to Date of first publication | |||
- | 2022-01-31T00:00:00 | + | 2023-01-31T00:00:00 |
Changes to Record Verification Date | |||
- | 2022/04/01 | + | 2024/08/28 |
Changes to Next update date | |||
- | 2023/04/01 | + | 2025/08/28 |
Current revision: