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 @ 1:29 PM
Ignite Modification Date:
2025-12-24 @ 1:29 PM
NCT ID:
NCT01457495
Eligibility Criteria:
Inclusion Criteria:
* A male or female between 12 and 16 weeks of age at the time of the first vaccination.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* Written informed consent obtained from the parents or guardians of the subject after they have been advised of the risks and benefits of the study in a language which they clearly understood, and before performance of any study procedure.
Exclusion Criteria:
* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
* Administration of chronic immunosuppressants or immune-modifying drugs during the study period.
* Administration of a vaccine not foreseen by the study protocol during the period starting from one month before each dose and ending one month after each dose.
* Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib diseases.
* History of/or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* History of allergic disease or reaction likely to be exacerbated by any component of the vaccine, including allergic reactions to neomycin and polymyxin B.
* Major congenital defects or serious chronic illness.
* Progressive neurological disorders.
* Administration of immunoglobulins and/or any blood products since birth and during the study period.
* Acute febrile illness at the time of planned vaccination.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Weeks
Maximum Age:
16 Weeks
Study:
NCT01457495
Study Brief:
Protocol Section:
NCT01457495