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 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT01432158
Eligibility Criteria:
Inclusion Criteria:
* Above 18 years of age.
* Participant is willing and able to give informed consent for participation after the nature of the study has been explained;
* In good health as determined by:
* medical history
* history-directed physical examination
* clinical judgment of the investigator
* Able (in the Investigators opinion) and willing to comply with all study requirements including be available for all the visits scheduled in the study
* Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
Exclusion Criteria:
* Have previously received a pneumococcal vaccine
* Have received vaccination with a vaccine containing either CRM197 or diphtheria toxoid within the past 12 months,
* Have had previous ascertained disease caused by C. diphtheriae, or S. pneumoniae in the past 5 years documented in their medical notes
* Have a history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
* Have a known or suspected autoimmune disease or impairment /alteration of immune function resulting from (for example):
* Receipt of immunostimulants
* Congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months or long-term systemic corticosteroid therapy (prednisolone or equivalent for more than two consecutive weeks within the past 3 months).
* Have a suspected or known HIV infection or HIV related disease;
* Have received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months
* Have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
* Have any condition, which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
* Participation in another clinical trial investigating a vaccine, a drug, a medical device, or a medical procedure
* Pregnancy as confirmed by a positive pregnancy test
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01432158
Study Brief:
Protocol Section:
NCT01432158