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 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT00099658
Eligibility Criteria:
Inclusion Criteria for All Infants:
* Birth weight of at least 2 kg (4.4 lbs)
* Written informed consent from parent or guardian
* Mother's HIV status documented after 24th week of pregnancy, if her infant joins Group 5 and is HIV uninfected
* Parent or guardian of infant intends to remain in the study area for the duration of the trial
Inclusion Criteria for HIV Infected Infants:
* HIV infected
* Participating in CIPRA SA-Project 2
Exclusion Criteria for All Infants:
* Blood products prior to study entry
* Immunosuppressant agents for more than 2 weeks, within 1 week of study entry
* Unable to tolerate oral medications
* Presence of any major, life-threatening congenital defect
* Acute illness or fever requiring hospitalization within 72 hours of immunization
* Grade 2 vaccine-related allergic reaction
* Grade 3 or 4 clinical or laboratory toxicity related to vaccination
* Use of any antiretroviral therapies other than those allowed in CIPRA SA-Project 2. Infants who received antiretroviral drugs used to prevent mother-to-infant HIV transmission are eligible for this study.
* Use of investigational drugs, systemic cytotoxic chemotherapy, or interleukin or other immune modulators
* Require certain medications
Exclusion Criteria for HIV Uninfected Infants:
* Vaccines prior to study entry. Infants who have received bacille Calmette-Guerin or oral polio vaccines are not excluded.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Weeks
Maximum Age:
10 Weeks
Study:
NCT00099658
Study Brief:
Protocol Section:
NCT00099658