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 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT02301702
Eligibility Criteria:
Inclusion Criteria:
1. Pregnant woman in late second or third trimester of pregnancy (i.e., after 27 weeks gestation),
2. Between the ages of 18 and 40 years (inclusive),
3. Intends to remain in the study area for at least seven months after delivery,
4. Has access to a mobile phone (defined as a phone in the possession of the participant or another family member with whom she lives),
5. Able to provide informed consent. If participant is illiterate, procedures to ensure full understanding of the research and consent process will be implemented according to international and federal guidelines.
Exclusion Criteria:
1. History of fever or oral temperature ≥ 38.0 degree Celsius within 48 hours prior to vaccination (women can be re-evaluated at a subsequent visit),
2. Received Tdap vaccine in the previous year,
3. History of serious systemic disease, including but not limited to: Guillain-Barré syndrome; known HIV, hepatitis B, or hepatitis C infection; heart/lung disease; uncontrolled diabetes mellitus (including gestational diabetes); chronic liver/kidney disease; clinically significant neurological disorders. This information will be based on self-reporting and (where possible) will be confirmed by health facility medical records.
4. High risk pregnancy, as identified by the Normas de Atención en Salud Integral, a guideline document published by the Ministry of Health, and also any previous complicated pregnancy or preterm delivery, spontaneous or medical abortion, or previous congenital anomaly,
5. Received immunoglobulin or other blood product within the preceding 3 month (with the exception of Rhogam),
6. History of allergy to any component of the vaccines (i.e. eggs, egg proteins, gelatin, formaldehyde, glutaraldehyde, polyethylene glycol p-isooctylphenyl ether, sucrose, aluminum hydroxide, polysorbate 80) or to latex,
7. History of severe reaction (including hypersensitivity) after receiving any vaccine,
8. History or evidence of immunosuppression (due to illness or treatment) or is on immunosuppressive therapy (includes long term use of steroids; use of high-dose inhaled steroids within past six months; with the exception of treatment with betamethasone or dexamethasone injections for the prevention of lung immaturity in the last trimester of pregnancy,
9. In the opinion of the study team - it would be unsafe or unsuitable for the pregnant mother or her fetus to receive the vaccine or participate in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT02301702
Study Brief:
Protocol Section:
NCT02301702