Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:18 AM
Ignite Modification Date:
2025-12-25 @ 5:18 AM
NCT ID:
NCT03137927
Eligibility Criteria:
Inclusion Criteria:
1. Males and females within the age range from 18 to 40 years
2. Health physical condition must be confirmed by routine clinical, laboratory and instrumental methods of diagnosis (absence of gastrointestinal, renal, cardiovascular diseases, hepatic, blood disorders, cancer and infectious diseases)
3. Body-weight index within range from 18 to 30 kg\\m2
4. Consent for using of reliable contraception (contraception sheath with spermicidal agents) while study and three months after the end of the study
5. Signed Participant Information Sheet and informed consent
6. Absence of specific antibodies (IgG, IgM, IgA) to Bordetella pertussis (negative ELISA results according to direction for ELISA test-system)
7. Absence of Bordetella pertussis DNA in nasopharyngeal swabs (negative PCR results)
Exclusion Criteria:
1. Whooping cough in past medical history
2. Vaccination against whooping cough over the past decade
3. Any other anti-infective immunization during last year
4. Any medical condition (renal diseases, hepatic disorders, haematological malignancies, malignant neoplasms and other diseases) which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
5. Vaccine-associated diseases or clinically significant vaccinal reactions in medical history
6. Clinically significant abnormal laboratory values at the discretion of the investigator
7. Use of any medications (in particular herbal medications and dietary supplements) within 30 days after day 0 at the discretion of the investigator
8. Positive results of HIV, hepatitis B or C
9. Use of narcotic drugs and/or a history of drug/alcohol abuse
10. Allergic diseases in medical history (in particular drug reaction and food allergy)
11. The subject has donated blood/plasma or suffered from blood loss of at least 450 ml (1 unit of blood) within 6 weeks prior to screening
12. Current participation in any other clinical trial or participation (and during the whole study) in any clinical trial in the previous 3 months prior to day 0
13. Inability to adhere to the protocol
14. Acute infectious diseases within 4 weeks prior to screening
15. Wheezing on the results of peakflowmetry
16. Significant ECG changes
17. Pregnancy or lactation (for female volunteers)
18. Systolic blood pressure less than 90 mmHg or over than 130 mmHg; diastolic blood pressure less than 60 mmHg or over 90 mmHg
19. Heart rate less than 60 bpm or more than 90 bpm
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT03137927
Study Brief:
Protocol Section:
NCT03137927