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 @ 7:49 PM
Ignite Modification Date:
2025-12-24 @ 7:49 PM
NCT ID:
NCT01119703
Eligibility Criteria:
Inclusion Criteria:
* Male or female aged 25 to 40 years old or 65 years of age or older at the prestudy (screening) visit
* Has no fever on day of screening
* Lacks Hepatitis B surface antigen seroreactivity
* If female 25 to 40 years of age, is not pregnant nor breastfeeding, and agrees to use effective contraception
Exclusion Criteria:
* Has a prior history of Hepatitis B Virus infection
* Has BMI (Body Mass Index) \>35
* If female 25 to 40 years of age, is pregnant, or expecting to conceive, donate eggs or breastfeed
* Has received immune globulin and/or blood products within 3 months prior to first dose received
* Has a history of immunosuppression resulting from disease (e.g., malignancy; human immunodeficiency virus \[HIV\] infection), or is currently taking corticosteroids or other immunosuppressive/cytotoxic therapy (cancer chemotherapy or organ transplantation)
* Has an active neoplastic disease
* Has had any infection including upper respiratory viral syndrome in the 6 weeks prior to planned collection of baseline laboratory samples
* Has received a live virus vaccine or an inactivated vaccine or is scheduled to receive a live virus vaccine or an inactivated vaccine in the period from 6 weeks prior to receipt of the first vaccine through the completion of all study visits
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Study:
NCT01119703
Study Brief:
Protocol Section:
NCT01119703