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 @ 1:03 PM
Ignite Modification Date:
2025-12-24 @ 1:03 PM
NCT ID:
NCT00317161
Eligibility Criteria:
Inclusion criteria:
• Healthy infants 56-83 days of age, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks and received a birth dose of hepatitis B vaccine within the first 72 hours of life.
Exclusion criteria:
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history \& physical examination.
* Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of study vaccine, or planned administration during the study period with the exception of oral polio vaccine (OPV).
* Use of any investigational or non-registered 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 (\>14 days) of immunosuppressants or other immune-modifying drugs since birth.
* Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
* Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, and/or meningococcal disease.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
56 Days
Maximum Age:
83 Days
Study:
NCT00317161
Study Brief:
Protocol Section:
NCT00317161