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 @ 4:50 AM
Ignite Modification Date:
2025-12-25 @ 4:50 AM
NCT ID:
NCT00868218
Eligibility Criteria:
Inclusion Criteria:
* Healthy volunteers (as concluded from the medical history, physical examination, and clinical judgment) aged 19 to 50 years old
* Females using a reliable method of contraception (from 4 weeks prior to the first vaccination until 4 weeks after the second vaccination) and a negative urine pregnancy test will be required before administration of each dose of vaccine
* Signed informed consent
* Subjects able to understand and comply with the study protocol and complete the Adverse Event Form
* Subjects able to attend the scheduled visits
* Subjects with normal pre-screening values. If a subjects prescreening samples lie outside the reference values he/she will only be included in the study based upon the medical evaluation of the clinical investigator
Exclusion Criteria:
* Persons with a history of anaphylaxis or serious reactions to any vaccine
* Persons with known hypersensitivity to any of the vaccine components
* Persons who have had a temperature \>38oC during the previous 72 hours
* Persons who have had an acute respiratory infection during the last 7 days
* Women who are pregnant or breast-feeding
* Persons with chronic illness at any stage that could interfere with trial conduct or compliance
* Persons who have received blood products or immunoglobulins parenterally during the previous 3 months
* Persons who have been vaccinated with any vaccine during the 4 weeks preceding the first trial vaccination
* Persons with known or suspected immunosuppressive disease or who use systemic immunosuppressive drugs
* Persons taking immunostimulant therapy
* Persons involved in another clinical trial during the last month.
* Suspected non-compliance
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
50 Years
Study:
NCT00868218
Study Brief:
Protocol Section:
NCT00868218