Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT04780035
Brief Summary:
The objective of the clinical study is to evaluate the tolerability, safety, immunogenicity and prophylactic efficacy of the EpiVacCorona vaccine in volunteers aged 18 and above.
The study tasks are to:
* evaluate the safety of the EpiVacCorona vaccine when administered twice intramuscularly;
* evaluate the tolerability of the EpiVacCorona vaccine when administered twice intramuscularly;
* identify any adverse events to the administration of the EpiVacCorona vaccine;
* investigate the humoral immune response following two doses of the EpiVacCorona vaccine;
* investigate the cell-mediated immune response following two doses of the EpiVacCorona vaccine;
* evaluate the prophylactic efficacy of the EpiVacCorona vaccine when administered twice intramuscularly.
Detailed Description:
The study will screen a maximum of 4,929 volunteers of both sexes aged 18 and above, of which 3,000 volunteers who meet the inclusion criteria and do not have the exclusion criteria will be randomized:
* 2,250 volunteers who will be vaccinated with the EpiVacCorona vaccine, twice intramuscularly at a dose of 0.5 ml;
* 750 volunteers who will be vaccinated with a placebo, twice intramuscularly at a dose of 0.5 ml.
If volunteers drop out of the study, they will not be replaced. All volunteers will be followed up by an investigator physician for 6 months following the first vaccination in order to identify possible late adverse events. In case the volunteer has any late reactions, he/she will be invited to the clinic to correct his/her condition.
Study:
NCT04780035
Study Brief:
Protocol Section:
NCT04780035