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:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT00291967
Eligibility Criteria:
Inclusion Criteria:
* Healthy infant between 6 and 10 weeks of age at the time of the first vaccination, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks.
Exclusion criteria:
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) or planned administration/ administration of vaccine not foreseen by the study protocol within 30 days preceding the first dose of study vaccine during study period, or planned use during study period with exception of oral polio vaccine (OPV).
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
* Hepatitis B and Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, and/or meningococcal disease with the exception of a birth dose of hepatitis B vaccine.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Weeks
Maximum Age:
10 Weeks
Study:
NCT00291967
Study Brief:
Protocol Section:
NCT00291967