Status:
COMPLETED
Maternal Tdap Immunization in Guatemala
Lead Sponsor:
Emory University
Collaborating Sponsors:
Universidad del Valle, Guatemala
Conditions:
Pertussis
Whooping Cough
Eligibility:
All Genders
18-40 years
Phase:
PHASE2
Brief Summary
Maternal immunization with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) is a potential strategy to protect young infants against pertussis before they are fully va...
Detailed Description
The proposed study is a randomized, blinded, controlled, vaccine trial of maternal Tdap vaccination during the third trimester of pregnancy (Tdap vaccination at 27-36 weeks gestation). Pregnant women ...
Eligibility Criteria
Inclusion
- Pregnant woman in late second or third trimester of pregnancy (i.e., after 27 weeks gestation),
- Between the ages of 18 and 40 years (inclusive),
- Intends to remain in the study area for at least seven months after delivery,
- Has access to a mobile phone (defined as a phone in the possession of the participant or another family member with whom she lives),
- 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
- 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),
- Received Tdap vaccine in the previous year,
- 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.
- 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,
- Received immunoglobulin or other blood product within the preceding 3 month (with the exception of Rhogam),
- 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,
- History of severe reaction (including hypersensitivity) after receiving any vaccine,
- 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,
- 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.
Key Trial Info
Start Date :
July 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 13 2019
Estimated Enrollment :
286 Patients enrolled
Trial Details
Trial ID
NCT02301702
Start Date
July 1 2016
End Date
August 13 2019
Last Update
October 16 2019
Active Locations (1)
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1
Universidad del Valle de Guatemala
Guatemala City, Guatemala, 01015