10 June 2021 - 5:24pm by Gladys | 28 August 2024 - 11:09am by FINLAY | ||
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Changes to Authorization date | |||
- | + | 2021-06-10 00:00:00 | |
Changes to Reference number | |||
- | In process | + | 05.010.21BA |
Changes to Recruitment status | |||
- | Pending | + | Complete |
Changes to Data sharing plan | |||
- | No | + | Yes |
Changes to Description of Data Sharing Plan | |||
- | + | The immunological individual data, and other supporting clinical documents, including study protocol, statistical analysis plan, and the informed consent form will be available after publication in specialized journals. Proposals should be sent to: dagarcia@finlay.edu.cu or: vicente.verez@finlay.edu.cu. These proposals must be reviewed and approved by the sponsor and investigator. Data access agreement must be signed. | |
Changes to Additional information to share | |||
- | + | The Study protocol, statistical analysis plan, and the informed consent form will be available after publication. | |
Changes to URL for additional information | |||
- | + | https://www.finlay.edu.cu/blog/category/sala-cientifica/ | |
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.
|
- | 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:
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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) | |||
Experimental Group: FINLAY-FR-2 + FINLAY-FR-1A.
| Experimental Group: FINLAY-FR-2 + FINLAY-FR-1A.
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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-1: 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 Final enrolment number | |||
- | + | 350 | |
Changes to Study completion date | |||
- | 2021-10-22T00:00:00 | + | 2022-07-06T00:00:00 |
Changes to Date of available results | |||
- | 2021-12-06T00:00:00 | + | 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 | |||
- | 2021/06/10 | + | 2024/08/28 |
Changes to Next update date | |||
- | 2022/06/10 | + | 2025/08/28 |
Changes to Results file | |||
+ | sites/default/files/RPCEC00000374-En.pdf |
Revision of 28 August 2024 - 11:09am: