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 @ 1:00 PM
Ignite Modification Date:
2025-12-24 @ 1:00 PM
NCT ID:
NCT02193061
Eligibility Criteria:
Inclusion Criteria:
* The subject is a boy or a girl 2 months ± one week old at the time of the first dose of the vaccine.
* The subject is considered to be healthy based on the clinical history and the physical examination.
* The subject has not received any anti-rotavirus vaccine.
* The parent/tutor fully understands the study's procedures and voluntarily accepts to participate and signs a written informed consent.
* The parent/tutor can meet the study's requirements, such as attending the programmed visits and filling in the journal.
* Written informed consent signed by the parent/tutor before any procedure.
Exclusion Criteria:
* The subject has a background of serious allergic reaction to any of the vaccine's components.
* The subject has a digestive tract malformation or acute/chronic disease.
* The subject has some kind of immunodeficiency including HIV.
* The subject suffers from a haemato-oncological disease.
* The subject has been under treatment with an immunosuppressing medicine including prednisone for two or more weeks.
* The subject has received gamma-globulin or any other blood-derived product or its administration is programmed during the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Weeks
Maximum Age:
10 Weeks
Study:
NCT02193061
Study Brief:
Protocol Section:
NCT02193061