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:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT02177032
Eligibility Criteria:
Inclusion Criteria:
1. Healthy males and females ≥ 1 years of age
2. Individuals/ individual's parents or legal guardians who have given written consent
3. Individuals in good health
4. Individuals who can comply with study procedures
Exclusion Criteria:
1. Behavioral or cognitive impairment or psychiatric disease.
2. Unable to comprehend and to follow all required study procedures for the whole period of the study.
3. History of illness or with an ongoing illness that may pose additional risk to the individual if he/she participates in the study.
4. Individuals ≥ 1 to ≤ 17 years of age, who have or ever had a malignancy.
5. Individuals ≥ 18 years of age, who have or who within the last 5 years, have had a malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder.
6. Known or suspected impairment of the immune system (including but not limited to HIV, autoimmune disorders, immunosuppressive therapy as applicable).
7. Female of childbearing potential who has not used any of the "acceptable contraceptive methods" for at least 2 months prior to study entry.
8. Female of childbearing potential, refusal to use an "acceptable birth control method" through day 50.
9. Female of childbearing potential, with a positive pregnancy test prior to enrollment.
10. Received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the previous 12 weeks.
11. Allergic to any of the vaccine components.
12. Allergic to any of the human rabies immunoglobulin components.
13. Contraindication or precaution against rabies vaccination.
14. Contraindication or precaution against man rabies immunoglobulin administration.
15. Planning to receive anti-malaria medications (e.g. Mefloquine) 14 days prior to day 1 vaccination through day 50.
16. Participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study.
17. Received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who are planning to receive any vaccine within 28 days from the study vaccines.
18. Body temperature ≥ 38.0°C (≥ 100.4°F) within 3 days of intended study vaccination.
19. Received rabies vaccines or rabies immunoglobulin or have been exposed to rabies.
20. Part of the study personnel or immediate family members of study personnel conducting this study.
21. Current or history of drug or alcohol abuse within the past 2 years.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Year
Study:
NCT02177032
Study Brief:
Protocol Section:
NCT02177032