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:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT04543669
Eligibility Criteria:
Inclusion Criteria:
* Age ≥16years
* Primed during infancy with an acellular pertussis vaccine
* Good general health status, as determined by history no greater than 30 days prior to administration of the first test article
* Written informed consent provided
* If female of child-bearing potential, has a negative pregnancy test on the day of consent and has agreed to continue adequate contraception until after the last blood draw.
Exclusion Criteria:
* Not primed in infancy with an acellular pertussis vaccine
* History of anemia
* Underlying chronic medical condition requiring ongoing monitoring by a physician (e.g., diabetes, seizure disorder)
* Underlying cardiac and/or pulmonary disease including hypertension, angina, prior myocardial infection, asthma, emphysema, chronic bronchitis, and pulmonary tuberculosis
* Pregnant (known before or established at the time of screening using a urine-based test)
* Immunocompromised (reporting HIV/AIDS positive or receiving immunosuppressive therapy involving steroids)
* Vaccinated against pertussis within previous 5 years
* Refusing to get an Adacel® (TdaP) vaccination dose
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
17 Years
Study:
NCT04543669
Study Brief:
Protocol Section:
NCT04543669