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 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT01926860
Eligibility Criteria:
Inclusion Criteria:
1. Male or female subjects aged ≥50
2. General good health as established by medical history and physical examination
3. Written informed consent
4. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is acceptable.
5. Available for all visits scheduled in this study.
6. No previous Pnc vaccination
7. No previous hepatitis A vaccine
8. No other vaccines administered 30 days prior to or during the study
Exclusion Criteria:
1. Previous pneumococcal or hepatitis A vaccination
2. Immunization with any other vaccine (oral or parenteral) within 4 weeks prior to study start or planned vaccination during the study
3. Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of vaccine; patients using oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent are excluded; inhaled or topical steroids are allowed
4. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
5. Pregnancy or lactation
6. Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever (fever is defined as body temperature of ≥38 °C).
7. Alcohol or drug abuse
8. Suspected non-compliance
9. Use of any investigational drug within 30 days preceding the study vaccine, or planned use during the study period
10. Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction based on the judgement of the investigator
11. Employee at the investigational site, relative or spouse of the investigator
12. Any other criteria which, in the investigator's opinion, would compromise the ability of the subject to participate in the study, the subject's well-being, or the outcome of the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT01926860
Study Brief:
Protocol Section:
NCT01926860