Status:
COMPLETED
TDAP Safety in Pregnant Women
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
Duke University
Centers for Disease Control and Prevention
Conditions:
Pertussis
Eligibility:
FEMALE
18-45 years
Brief Summary
The purpose of this observational study is to evaluate the safety of Tetanus Toxoid Reduced Diphtheria, Toxoid, and Acelluar Pertussis Vaccine (Tdap) in pregnant women at ≥ 20 weeks 0 days gestation r...
Detailed Description
This is an observational study of both pregnant and non-pregnant women. Vaccine administration in the pregnant population will be part of routine care. Vaccine administration in the non-pregnant women...
Eligibility Criteria
Inclusion
- Inclusion:
- Subjects who meet the following criteria will be eligible to participate in this observational study. Tdap administration will be given as routine standard of care.
- Pregnant and non-pregnant women, as determined by medical history, aged 18 - 45 years of age inclusive
- For pregnant women only - Singleton gestation ≥ 20 weeks 0 days gestation - ≤34 weeks 0 days gestation based on reconciliation of last menstrual period and ultrasound dating. Estimated due date (EDD) and Gestational Age (GA) - EDD will be based on reconciliation of a "sure" first day of the last menstrual period (LMP) and earliest dating ultrasound. If the LMP is uncertain, then the earliest dating ultrasound will be used to determine EDD and GA. If the ultrasound derived-EDD is in agreement with sure-LMP derived EDD, then the LMP-derived EDD is used to determine GA. If the ultrasound derived EDD is not in agreement with the LMP-derived EDD, the ultrasound-derived EDD is used to determine GA.
- Intention of receiving Tdap vaccine based on ACIP guidelines
- Willing to provide written informed consent prior to initiation of any study procedures
- English or Spanish literate
- Intention of being available for entire study period and complete all relevant study procedures
- Exclusion:
- Subjects who meet the following criteria will not be eligible to participate in this study:
- Febrile illness within the last 24 hours or an oral temperature \> 100.4oF (\> 38oC) prior to Tdap administration
- Severe allergic reaction (e.g., anaphylaxis) to any component of Tdap or any other diphtheria toxoid, tetanus toxoid and pertussis antigen containing vaccine
- Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous pertussis antigen-containing vaccine.
- Known or suspected impairment of immunologic function including active infection with HIV, hepatitis B or C, current use of glucocorticoids, i.e., oral, parenteral, and high-dose inhaled steroids, and immunosuppressive or cytotoxic drugs.
- Note, if a woman were to require antenatal corticosteroids for benefit of fetal lung maturity within 8 days post enrollment, she would not be excluded from the study for reactogenicity analysis. However, if antenatal corticosteroids were received anytime between vaccination and 28-day sample collection for serologic studies, she would be excluded from serologic studies as they could be altered by steroid receipt.
- Receipt of any licensed vaccine OR investigational product within 1 week prior to Tdap vaccination in this study or planning receipt of any vaccines during 8-day post-vaccination period.
- Note, any woman receiving an investigational vaccine or live vaccine inadvertently at any time during pregnancy will be excluded from analysis. (Note, inadvertent receipt of licensed HPV vaccine or any other inactivated licensed vaccine outside of the parameters specified above is not a reason for exclusion).
- Any condition which, in the opinion of the investigators, may pose a health risk to the subject or interfere with the evaluation of the study objectives.
- Anyone who is a relative of any research study personnel
- Anyone who is an employee of any research study personnel
- For pregnant women only
- Tdap/Td/TT receipt during current pregnancy prior to study enrollment
- Signs or symptoms of active preterm labor, defined as regular uterine contractions with cervical change
- For non-pregnant women only
- Intention of becoming pregnant during study participation
- Anyone who is already enrolled or plans to enroll in another clinical trial with an investigational product within 30 days of Tdap receipt. Co-enrollment in observational or behavioral intervention studies are allowed at any time while enrollment in a clinical trial involving an investigational product (other than vaccine) may occur after 30 days following Tdap receipt. Receipt of inactivated vaccines during pregnancy, including routinely recommended inactivated influenza vaccine, given as part of usual care, is not an exclusion for this study, except during the 8 days after Tdap vaccination
Exclusion
Key Trial Info
Start Date :
May 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 18 2017
Estimated Enrollment :
375 Patients enrolled
Trial Details
Trial ID
NCT02209623
Start Date
May 1 2014
End Date
December 18 2017
Last Update
December 20 2017
Active Locations (2)
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1
Duke University Dept of ObGyn, Division of Maternal-Fetal Medicine
Durham, North Carolina, United States, 27705
2
Vanderbilt Medical Center, Vaccine Research Program
Nashville, Tennessee, United States, 37232