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 @ 2:50 PM
Ignite Modification Date:
2025-12-24 @ 2:50 PM
NCT ID:
NCT03332459
Eligibility Criteria:
Inclusion Criteria:
* Male or female infants and children who were previously randomized in study 64041575RSV2004 for the treatment of respiratory syncytial virus (RSV) infection and who completed the planned course of the study drug and the last study-related visit of study 64041575RSV2004
* The participant's legally acceptable representative must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing for the participant to participate in the study
Exclusion Criteria:
* The participants legally acceptable representative, i.e, parent/legal guardian/caregiver, is not able to maintain reliable communication with the investigator
* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
56 Days
Maximum Age:
39 Months
Study:
NCT03332459
Study Brief:
Protocol Section:
NCT03332459