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 @ 3:25 AM
Ignite Modification Date:
2025-12-25 @ 3:25 AM
NCT ID:
NCT01294605
Eligibility Criteria:
Inclusion Criteria:
* Only subjects for whom the investigator believes the requirements of the protocol will be complied with will be enrolled in the study
* A male or female adult \>= 40 years of age
* Written informed consent to be obtained from the subject prior to study entry
* No history of diphtheria or tetanus toxoid containing vaccination in the last 20 years, including those who have never been vaccinated and those with an unknown vaccination status.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* subject should not be pregnant or plan to become pregnant.
Exclusion Criteria:
* Use of any investigational or non-registered product 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 of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures
* Acute disease at the time of enrolment.
* Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
* Pregnant or lactating female
* Female planning to become pregnant or planning to discontinue contraceptive precautions
* Previous vaccination with a meningococcal-conjugate vaccine, Prevenar™ or other experimental conjugated pneumococcal vaccines
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
* Any confirmed or suspected immunosuppressive or immunodeficient condition
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT01294605
Study Brief:
Protocol Section:
NCT01294605