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 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT00158756
Eligibility Criteria:
Inclusion criteria:
* Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol.
* Administration of one dose of hepatitis B vaccine at birth.
* A male or female between, and including, 11 and 17 weeks of age at the time of the first DTPw vaccination.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Exclusion criteria:
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before the first vaccine dose or planned administration during the study period with the exception of oral polio vaccine.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required)
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Weeks
Maximum Age:
4 Months
Study:
NCT00158756
Study Brief:
Protocol Section:
NCT00158756