Created at Source Raw Value Validated value
June 25, 2024, noon usa

inclusion criteria: 1. male or female participants between 18 and 55 years of age 2. with the ability and willingness to comply with the prohibitions and restrictions specified in the protocol. 3. healthy volunteers, which will be determined by the history referred to interrogation, physical examination, and principal investigator's criteria. 4. in fertile female volunteers, negative pregnancy test at the beginning of the study and commitment to use a contraceptive method from the date of signing the consent form until 3 months after vaccine study application. use of a hormonal contraceptive method must begin at least 28 days prior to study vaccine application. the investigator should assess potential contraceptive method failure (e.g. non-compliance, recent onset) in relation to vaccination. acceptable effective methods for this study include: a) hormonal contraceptive method: i) combined (containing estrogen and progestin) associated with the inhibition of ovulation (oral, intravaginal or transdermal); ii) with progestin only, associated with the inhibition of ovulation (oral, injectable or implantable); b) intrauterine device;. c) intrauterine hormone release system; d) bilateral tubal ligation/occlusion procedure; e) single couple with vasectomy; f) sexual abstinence, which will be considered effective only if it is defined as abstaining from heterosexual relations from the date of signing the consent until 3 months after receiving the study vaccine. the reliability of sexual abstinence should be assessed in relation to the duration of the study and the participant's usual and preferred lifestyle. 5. participant who agrees to do not donate bone marrow, blood or blood products until 3 months after the last dose of study vaccine; 6. participant who is able to read, understand, and complete electronic questionnaires about signs and symptoms of covid-19 surveillance; 7. negative pcr for the sars-cov-2 virus. 8. with laboratory analysis without clinically significant variations within the 30 days prior to receiving the first dose of the study vaccine, which must include: 1. complete cell blood count (hemoglobin (hb), leukocyte count and leukocyte formula, platelet count; 2. complete liver test: total and direct bilirubin, alanine aminotransaminases (alt) and aspartate aminotransferase (ast), lactate dehydrogenase (ldh), alkaline phosphatase (alf). 3. biochemistry: glycemia, urea, creatinine; 4. qualitative c-reactive protein (pcr); 5. complete urine. 9. capable of granting their informed consent signed and dated by the volunteer under study, and the authorized physician.

inclusion criteria: 1. male or female participants between 18 and 55 years of age 2. with the ability and willingness to comply with the prohibitions and restrictions specified in the protocol. 3. healthy volunteers, which will be determined by the history referred to interrogation, physical examination, and principal investigator's criteria. 4. in fertile female volunteers, negative pregnancy test at the beginning of the study and commitment to use a contraceptive method from the date of signing the consent form until 3 months after vaccine study application. use of a hormonal contraceptive method must begin at least 28 days prior to study vaccine application. the investigator should assess potential contraceptive method failure (e.g. non-compliance, recent onset) in relation to vaccination. acceptable effective methods for this study include: a) hormonal contraceptive method: i) combined (containing estrogen and progestin) associated with the inhibition of ovulation (oral, intravaginal or transdermal); ii) with progestin only, associated with the inhibition of ovulation (oral, injectable or implantable); b) intrauterine device;. c) intrauterine hormone release system; d) bilateral tubal ligation/occlusion procedure; e) single couple with vasectomy; f) sexual abstinence, which will be considered effective only if it is defined as abstaining from heterosexual relations from the date of signing the consent until 3 months after receiving the study vaccine. the reliability of sexual abstinence should be assessed in relation to the duration of the study and the participant's usual and preferred lifestyle. 5. participant who agrees to do not donate bone marrow, blood or blood products until 3 months after the last dose of study vaccine; 6. participant who is able to read, understand, and complete electronic questionnaires about signs and symptoms of covid-19 surveillance; 7. negative pcr for the sars-cov-2 virus. 8. with laboratory analysis without clinically significant variations within the 30 days prior to receiving the first dose of the study vaccine, which must include: 1. complete cell blood count (hemoglobin (hb), leukocyte count and leukocyte formula, platelet count; 2. complete liver test: total and direct bilirubin, alanine aminotransaminases (alt) and aspartate aminotransferase (ast), lactate dehydrogenase (ldh), alkaline phosphatase (alf). 3. biochemistry: glycemia, urea, creatinine; 4. qualitative c-reactive protein (pcr); 5. complete urine. 9. capable of granting their informed consent signed and dated by the volunteer under study, and the authorized physician.

Dec. 21, 2022, 8 a.m. usa

inclusion criteria: male or female participants between 18 and 55 years of age with the ability and willingness to comply with the prohibitions and restrictions specified in the protocol. healthy volunteers, which will be determined by the history referred to interrogation, physical examination, and principal investigator's criteria. in fertile female volunteers, negative pregnancy test at the beginning of the study and commitment to use a contraceptive method from the date of signing the consent form until 3 months after vaccine study application. use of a hormonal contraceptive method must begin at least 28 days prior to study vaccine application. the investigator should assess potential contraceptive method failure (e.g. non-compliance, recent onset) in relation to vaccination. acceptable effective methods for this study include: a) hormonal contraceptive method: i) combined (containing estrogen and progestin) associated with the inhibition of ovulation (oral, intravaginal or transdermal); ii) with progestin only, associated with the inhibition of ovulation (oral, injectable or implantable); b) intrauterine device;. c) intrauterine hormone release system; d) bilateral tubal ligation/occlusion procedure; e) single couple with vasectomy; f) sexual abstinence, which will be considered effective only if it is defined as abstaining from heterosexual relations from the date of signing the consent until 3 months after receiving the study vaccine. the reliability of sexual abstinence should be assessed in relation to the duration of the study and the participant's usual and preferred lifestyle. participant who agrees to do not donate bone marrow, blood or blood products until 3 months after the last dose of study vaccine; participant who is able to read, understand, and complete electronic questionnaires about signs and symptoms of covid-19 surveillance; negative pcr for the sars-cov-2 virus. with laboratory analysis without clinically significant variations within the 30 days prior to receiving the first dose of the study vaccine, which must include: complete cell blood count (hemoglobin (hb), leukocyte count and leukocyte formula, platelet count; complete liver test: total and direct bilirubin, alanine aminotransaminases (alt) and aspartate aminotransferase (ast), lactate dehydrogenase (ldh), alkaline phosphatase (alf). biochemistry: glycemia, urea, creatinine; qualitative c-reactive protein (pcr); complete urine. capable of granting their informed consent signed and dated by the volunteer under study, and the authorized physician.

inclusion criteria: male or female participants between 18 and 55 years of age with the ability and willingness to comply with the prohibitions and restrictions specified in the protocol. healthy volunteers, which will be determined by the history referred to interrogation, physical examination, and principal investigator's criteria. in fertile female volunteers, negative pregnancy test at the beginning of the study and commitment to use a contraceptive method from the date of signing the consent form until 3 months after vaccine study application. use of a hormonal contraceptive method must begin at least 28 days prior to study vaccine application. the investigator should assess potential contraceptive method failure (e.g. non-compliance, recent onset) in relation to vaccination. acceptable effective methods for this study include: a) hormonal contraceptive method: i) combined (containing estrogen and progestin) associated with the inhibition of ovulation (oral, intravaginal or transdermal); ii) with progestin only, associated with the inhibition of ovulation (oral, injectable or implantable); b) intrauterine device;. c) intrauterine hormone release system; d) bilateral tubal ligation/occlusion procedure; e) single couple with vasectomy; f) sexual abstinence, which will be considered effective only if it is defined as abstaining from heterosexual relations from the date of signing the consent until 3 months after receiving the study vaccine. the reliability of sexual abstinence should be assessed in relation to the duration of the study and the participant's usual and preferred lifestyle. participant who agrees to do not donate bone marrow, blood or blood products until 3 months after the last dose of study vaccine; participant who is able to read, understand, and complete electronic questionnaires about signs and symptoms of covid-19 surveillance; negative pcr for the sars-cov-2 virus. with laboratory analysis without clinically significant variations within the 30 days prior to receiving the first dose of the study vaccine, which must include: complete cell blood count (hemoglobin (hb), leukocyte count and leukocyte formula, platelet count; complete liver test: total and direct bilirubin, alanine aminotransaminases (alt) and aspartate aminotransferase (ast), lactate dehydrogenase (ldh), alkaline phosphatase (alf). biochemistry: glycemia, urea, creatinine; qualitative c-reactive protein (pcr); complete urine. capable of granting their informed consent signed and dated by the volunteer under study, and the authorized physician.