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 @ 10:09 PM
Ignite Modification Date:
2025-12-24 @ 10:09 PM
NCT ID:
NCT00081835
Eligibility Criteria:
* INCLUSION CRITERIA:
To be eligible to enroll in this study, a prospective participant must satisfy all of the following inclusion criteria:
1. The participant, or their parent or guardian if younger than 18 years at enrollment, is able to understand and sign an approved consent form. Any minor participant with adequate reading and writing skills must also sign an assent using a form approved by the local Institutional Review Board or Independent Ethics Committee (IRB/IEC). Minors with verbal skills but without adequate reading and writing skills should have an acknowledgement signed by their parent or guardian to certify that verbal assent to participate was obtained.
2. The participant must have received the vaccinia vaccination, been exposed to a person vaccinated with vaccinia who has skin lesions, or been exposed directly to accidental splash of the vaccine.
3. Have signs and symptoms consistent with ocular vaccinia.
4. To be eligible for randomization the participant must have corneal involvement defined as a keratitis with any abnormality of the epithelium, stroma, or endothelium consistent with vaccinia infection.
EXCLUSION CRITERIA:
To be randomized to the VIGIV/placebo treatment, a proposed participant must not satisfy the following exclusion criteria:
1. Children with body weight less than 10 kg.
2. Have a known severe reaction to the IV or IM administration of human immunoglobulin.
3. Have known severe acute allergic reactions to the non-active ingredients of polysorbate 80, maltose, or the trace amounts of TNBP or Triton X-100 used in the preparation of VIGIV.
4. Has received VIGIV within 6 months prior to randomization.
5. Pregnant women, unless an approved, specific additional consent statement attesting to awareness of the unknown risk of VIGIV therapy during pregnancy is understood and signed by the participant.
6. Have orbital cellulites.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Study:
NCT00081835
Study Brief:
Protocol Section:
NCT00081835