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 @ 3:27 PM
Ignite Modification Date:
2025-12-24 @ 3:27 PM
NCT ID:
NCT00319592
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent obtained.
* Aged ≥18 to \<49 years.
* In good general health.
* Available for the study duration, including all planned follow-up visits.
* Females must have negative pregnancy test and be using adequate form of contraception
Exclusion Criteria:
* Clinically significant abnormalities on laboratory and vital sign assessments.
* Anaphylaxis or other serious adverse reactions
* Administration of another vaccine within 30 days of study treatment period.
* Physical examination indicating any significant medical condition.
* Intention to travel out of the area prior to the study visit on Day 56.
* Seropositive to Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) or positive for Hepatitis B Surface Antigen.
* Pregnancy.
* Excessive alcohol consumption, drug abuse.
* Involvement in another clinical study within 60 days preceding the screening visit and during study treatment period.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
48 Years
Study:
NCT00319592
Study Brief:
Protocol Section:
NCT00319592