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 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT00325156
Eligibility Criteria:
Inclusion criteria
* Subjects must have been enrolled in the Rota-028 study.
* A male or female between, and including, 11 and 17 weeks of age at the time of the first vaccination.
* Written informed consent obtained from the parent or guardian of the subject.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
Exclusion criteria
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period.
* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of the vaccine and ending 30 days after.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* A family history of congenital or hereditary immunodeficiency.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures.
* Acute disease at the time of enrolment.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
11 Weeks
Maximum Age:
17 Weeks
Study:
NCT00325156
Study Brief:
Protocol Section:
NCT00325156