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 @ 12:36 PM
Ignite Modification Date:
2025-12-24 @ 12:36 PM
NCT ID:
NCT00322361
Eligibility Criteria:
Inclusion Criteria:
* Healthy male and female full-term (37-42 weeks gestation) neonates (birth to 10 days of age)
* Born to mothers with documented negative test for HBsAg within 9 months prior to delivery
Exclusion Criteria:
* Infant born to mother with no prenatal care
* Known or suspected impairment of immunologic function
* Prior vaccination with any hepatitis B vaccine for infant or mother(within 6 months prior to the birth of infant.)
* Recent(\<72 hours) history of febrile illness \>/= 99.5 degrees F (\>/= 37.5 degrees C) axillary or \>/= 100.5 degrees F (\>/= 38.1 degrees C) rectal
* Any prior administration of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product, or the receipt by the mother of either immunoglobulin or HBIG within 6 months prior to birth of the infant
* Receipt of investigational vaccines by mother or infant within 3 months prior to first injection with study vaccine or if scheduled to be given to the infant during the study
* Known or suspected hypersensitivity to any component of study vaccine (e.g., aluminum, yeast)
* Any infant who cannot be adequately followed for study visits during the course of the clinical study
* Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
10 Days
Study:
NCT00322361
Study Brief:
Protocol Section:
NCT00322361