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 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT00627458
Eligibility Criteria:
Inclusion Criteria:
* Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
* Subjects must have completed the full three-dose primary vaccination course with one of the formulations of the DTPa-HBV-IPV/Hib vaccine in primary study 106786.
* A male or female between, and including, 16 and 20 months of age at the time of booster vaccination.
* Written informed consent obtained from the parent or guardian of the subject
* Healthy subjects 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 within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose.
* Participation in another clinical study, between the primary study 106786 and the present booster study, or at any time during the study, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* Planned administration or administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the booster dose and ending 30 days after the booster dose.
* Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib booster vaccination or disease since the conclusion visit of study 106786.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
* Acute disease at the time of enrolment.
* Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Months
Maximum Age:
20 Months
Study:
NCT00627458
Study Brief:
Protocol Section:
NCT00627458