10 June 2021 - 6:24pm by Gladys | 1 April 2022 - 10:52pm by FINLAY | ||
---|---|---|---|
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 Intervention(s) | |||
Experimental Group: FINLAY-FR-2 + FINLAY-FR-1A.
| Experimental Group: FINLAY-FR-2 + FINLAY-FR-1A.
| ||
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-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.
|
Changes to Final enrolment number | |||
- | + | 350 | |
Changes to Study completion date | |||
- | 2021-10-22T00:00:00 | + | 2021-10-07T00:00:00 |
Changes to Date of available results | |||
- | 2021-12-06T00:00:00 | + | 2022-02-20T00:00:00 |
Changes to Record Verification Date | |||
- | 2021/06/10 | + | 2022/04/01 |
Changes to Next update date | |||
- | 2022/06/10 | + | 2023/04/01 |
Changes to Results file | |||
+ | sites/default/files/RPCEC00000374-En.pdf |
Revision of 1 April 2022 - 10:52pm: