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 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT00138320
Eligibility Criteria:
Inclusion Criteria:
1. Enrolled in the Herpevac Trial for Women.
2. Has received at least two doses of either the candidate or control vaccine.
3. Pregnant.
4. Written informed consent obtained from the participant.
5. Willing to have her blood collected either at the time of delivery or within 15 days before or after delivery. If blood is to be collected by the health care provider who will be presiding at the delivery, the participant must be willing to give permission for study personnel to contact that health care provider to arrange the collection of blood.
6. Willing to have either umbilical vein blood collected at the time of delivery or blood collected from her neonate within 15 days after delivery. If blood is to be collected from the umbilical vein, the participant must be willing to give permission for study personnel to contact the presiding health care provider to arrange the collection of blood.
7. A participant whom the investigator believes can and will comply with the requirements of the protocol.
Exclusion Criteria:
1. Termination of the pregnancy, other than live birth.
2. Entry violation in the Herpevac Trial for Women at enrollment.
3. Receipt of immunoglobulin or blood products within 4 months prior to expected date of delivery.
4. History or current clinical evidence of herpes simplex virus infection.
Maternal withdrawal criteria: If any of the following occur after enrollment, the subject will be withdrawn prior to obtaining any blood samples:
1. Termination of the pregnancy, other than live birth.
2. Determination that the subject was enrolled in the Herpevac Trial for Women in violation of that study's entry criteria.
3. Receipt of immunoglobulin or blood products within 4 months prior to expected or actual date of delivery.
4. Inability to collect umbilical vein blood at the time of delivery or neonatal blood within 15 days after birth due to logistical or other reasons.
Infant withdrawal criteria: If any of the following occurs during the study, the 2 and 6-month blood samples (or the 6-month sample only if the occurrence follows the 2-month blood draw) will not be collected from the infant:
1. Participant \[mother\] chooses not to participate, or continue her participation in, the optional arm of the study.
2. Inability to collect neonatal blood within 15 days after birth due to logistical or other reasons from infants for whom umbilical vein blood was not collected.
3. Death of the infant.
4. Adoption of the infant prior to completion of the study.
5. At the discretion of the investigator.
6. Receipt of immunoglobulin or blood products by the infant prior to blood draw.
Healthy Volunteers:
True
Sex:
ALL
Maximum Age:
30 Years
Study:
NCT00138320
Study Brief:
Protocol Section:
NCT00138320