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 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT01153893
Eligibility Criteria:
Inclusion Criteria:
* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol.
* A male or female, between and including 15-21 months of age at the time of visit 1.
* For the Pn-Pn group, subjects who completed the full vaccination course in study NCT00678301. For the Zil-Pn group, subjects who were previously enrolled in the control group of study NCT00678301.
* Written informed consent, signed or thumb printed, obtained from the parent(s)/LAR(s) of the subject. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by a witness.
* 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 other than the study vaccine(s)/product(s) within 30 days preceding the first dose of vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
* Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after. Locally recommended vaccines for example Oral Polio Vaccine or influenza vaccine are always allowed, even if concomitantly administered with the study vaccines, but should be documented in the CRF.
* Concurrently participating in another clinical study at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* Administration of any pneumococcal vaccine since the end of study NCT00678301.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, since the end of study NCT00678301, based on medical history and physical examination.
* Major congenital defects or serious chronic illness.
* History of any progressive neurological disorders or seizures.
* Acute disease and/or fever at the time of enrolment.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
* Administration of immunoglobulins and/or any blood products less than 3 months prior to visit 1 or planned use during the study.
* Child in care.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
15 Months
Maximum Age:
21 Months
Study:
NCT01153893
Study Brief:
Protocol Section:
NCT01153893