CompletedPhase 4

Tdap Vaccine in Post-Partum Women

United States55 participantsStarted 2012-10-26

Plain-language summary

Monitoring immune response and longevity in serum and milk after Tdap administration to postpartum women. The clinical trial will involve women (aged 18 - 45 years) who have just delivered full-term infants (greater than or equal to 37 completed weeks of gestation) at Vanderbilt University Medical Center. The enrollment period will be fifteen months. The duration is over two years of observation.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓Healthy, postpartum women as determined by medical history aged 18 - 45 years of age inclusive. -Women 1-4 days postpartum from delivery of full-term infants. Full-term will be defined as estimated gestational age of greater than or equal to 37 completed weeks of pregnancy determined by menstrual dating and concordant with ultrasound findings as per ACOG bulletin #101). -Provide written informed consent prior to initiation of any study procedures. -Available for the entire study period. -Able to understand and complete all relevant study procedures during study participation (women who ultimately have limited ability to breast feed after enrollment will not be excluded from the study).

Exclusion criteria

✕Prior receipt of a tetanus or diphtheria-containing vaccine within two years of enrollment. -Prior receipt of a tetanus and diphtheria toxoid and acellular pertussis vaccine within two years of enrollment. -Known or suspected impairment of immunologic function. -Febrile illness within the last 24 hours or an oral temperature \>/= 100.4 degrees F (\>/= 38 degrees C) at the time of enrollment. -History of documented tetanus, diphtheria, or pertussis disease within the preceding 5 years. -History of allergic or adverse reaction to diphtheria, tetanus, or pertussis vaccines. -Receipt of any steroids, immunoglobulins, other blood products/transfusion within the past six months- excluding Rh immunoglobulin (Rhogam™ and Rhophylac™). -Is enrolled or plans to enroll in another clinical trial with an investigational product while participating in this study (observational studies are allowed). -Known active infection with HIV, hepatitis B, or hepatitis C. -History of alcohol or drug abuse in the last 5 years. -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. -Any woman with health condition who is currently taking glucocorticoids, i.e., oral, parenteral, and high-dose inhaled steroids, and immunosuppressive or cytotoxic drugs. -Sensitive to latex, based on package insert -Progressive or unstable neurologic condition, based on package insert. -Receipt of influenza or other vaccines concomitantly administered or for 42 days following Adacel, based on package insert.

What they're measuring

Geometric Mean Fold Rise in Serum Immunoglobulin G (IgG) by ELISA at Week 2

Timeframe: Prior to and 2 weeks following vaccination

Geometric Mean Fold Rise in Serum IgG by ELISA at Week 6

Timeframe: Prior to and 6 weeks following vaccination

Geometric Mean Fold Rise in Serum IgG by ELISA at Month 6

Timeframe: Prior to and 6 months following vaccination

Geometric Mean Fold Rise in Serum IgG by ELISA at Month 12

Timeframe: Prior to and 12 months following vaccination

Geometric Mean Fold Rise in Serum IgG by ELISA at Month 18

Timeframe: Prior to and 18 months following vaccination

Geometric Mean Fold Rise in Serum IgG by ELISA at Month 24

Timeframe: Prior to and 24 months following vaccination

ELISA Geometric Mean Concentrations (GMC) of Serum IgG to PT, FHA, PRN and FIM at Baseline

Timeframe: Baseline (prior to vaccination)

Trial details

NCT IDNCT01711645

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2015-08-28

Results submitted2016-11-23

View on ClinicalTrials.gov More Diphtheria trials