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 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT00138333
Eligibility Criteria:
Inclusion Criteria: 1) Parent/guardian gives written informed consent. 2) Good health as determined by negative gestational history, subject's medical history and physical assessment. Medical history will include a review of the major body systems (e.g., ear-nose-throat, cardiovascular, respiratory, neurological, gastrointestinal, genitourinary, hematological). 3) Newborn cohort: within 3 days of birth and gestational age = 32 weeks and \< 37 weeks and a birth weight = 2000 grams and \< 3000 grams. 4) Able to attend the scheduled visits and to comply with the study procedures. Exclusion Criteria: 1) Infant history of vaccinations and date received is unknown or undocumented. 2) Known history of high-level mercury exposure in mother or infant. 3) Any contraindication to routine vaccinations. 4) Clinically significant findings on review of systems (determined by investigator or sub-investigator to be sufficient for exclusion). 5) Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth. 6) HIV-positive mother by history. 7) Personal or immediate family history of congenital immune deficiency. 8) Developmental delay or neurological disorders.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
32 Weeks
Maximum Age:
36 Weeks
Study:
NCT00138333
Study Brief:
Protocol Section:
NCT00138333