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:
NCT00345956
Eligibility Criteria:
Inclusion Criteria:
* Healthy male or female infant between, and including, 6 and 10 weeks of age with a birth weight of \> 2000 grams.
* Written informed consent obtained from the parent or guardian of the subject.
Exclusion Criteria:
* Use of any investigational or non-registered product (drug or vaccine) other than the HRV liquid vaccine or placebo within 30 days preceding the first dose of HRV liquid vaccine or placebo, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
* Planned administration/ administration of a vaccines not foreseen by the study protocol except for DTPw, HBV and OPV vaccines within 14 days before each dose of HRV liquid vaccine or placebo and ending 14 days after.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
* History of allergic disease or reactions likely to be exacerbated by any component of the HRV liquid vaccine or placebo.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Weeks
Maximum Age:
10 Weeks
Study:
NCT00345956
Study Brief:
Protocol Section:
NCT00345956