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 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT01536405
Eligibility Criteria:
Inclusion Criteria:
* Negative clinical history for measles, mumps, rubella, varicella, and zoster
Exclusion Criteria:
* Received any measles, mumps, rubella, or varicella vaccine, either alone or in any combination at any time prior to the study, or is anticipated to receive any of these vaccines outside of study protocol, either alone or in any combination, during the study
* Received immune globulin, a blood transfusion or blood-derived products (does not include autologous blood/blood products) within 5 months (150 days) prior to any dose of the study vaccines or plans to receive these products while enrolled in this study
* Exposed to measles, mumps, rubella, varicella, or zoster within 4 weeks prior to the study vaccination
* Any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity, including that resulting from steroid use or other immunosuppressive therapy
* Received 1) systemic immunomodulatory steroids \[greater than the
equivalent of 2 mg/kg total daily dose of prednisone\] within 3 months prior to
entering the study, or 2) any dose of systemic immunomodulatory steroids within
7 days prior to entering study, or 3) is expected to require systemic immunomodulatory steroids through the course of the study
* History of allergy or anaphylactoid reaction to gelatin, sorbitol, neomycin, egg proteins (eggs or egg products), chicken proteins, or any component of the study vaccines
* Received salicylates (eg, aspirin or aspirin-containing products) within 14 days prior to study vaccination
* Diagnosis of an active neurological disorder. Enrollment may be considered
when the disease process has been stabilized
* History of seizure disorder, including single febrile seizure
* Diagnosis of active untreated tuberculosis
* History of thrombocytopenia
* Born to a human immunodeficiency virus (HIV) infected mother
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
23 Months
Study:
NCT01536405
Study Brief:
Protocol Section:
NCT01536405