Tdap Vaccine in Post-Partum Women
Diphtheria · Pertussis · Tetanus
Bottom Line
View on ClinicalTrials.gov: NCT01711645 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum phosphate (Biological)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Fold Rise in Serum Immunoglobulin G (IgG) by ELISA at Week 2 |
4.8; 8.6; 21.6; 22.4 | — |
| PRIMARY Geometric Mean Fold Rise in Serum IgG by ELISA at Week 6 |
3.5; 6.7; 19.1; 18.6 | — |
| PRIMARY Geometric Mean Fold Rise in Serum IgG by ELISA at Month 6 |
1.9; 3.4; 8.1; 10.1 | — |
| PRIMARY Geometric Mean Fold Rise in Serum IgG by ELISA at Month 12 |
1.6; 2.5; 5.1; 6.9 | — |
| PRIMARY Geometric Mean Fold Rise in Serum IgG by ELISA at Month 18 |
1.6; 2.4; 4.6; 6.8 | — |
| PRIMARY Geometric Mean Fold Rise in Serum IgG by ELISA at Month 24 |
1.4; 2.2; 4.9; 7.0 | — |
| PRIMARY ELISA Geometric Mean Concentrations (GMC) of Serum IgG to PT, FHA, PRN and FIM at Baseline |
6.6; 15.9; 20.3; 38.1 | — |
| PRIMARY ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Week 2 |
51.5; 154.3; 581.5; 1156.3 | — |
| PRIMARY ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Week 6 |
37.5; 126.1; 496.8; 905.1 | — |
| PRIMARY ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 6 |
19.2; 62.4; 212.3; 492.8 | — |
| PRIMARY ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 12 |
15.1; 46.2; 141.1; 368.7 | — |
| PRIMARY ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 18 |
15.1; 44.6; 121.1; 330.7 | — |
| PRIMARY ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 24 |
10.8; 39.0; 114.1; 298.0 | — |
| PRIMARY Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Week 2 |
31; 45; 43; 34 | — |
| PRIMARY Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Week 6 |
21; 44; 42; 34 | — |
| PRIMARY Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 6 |
5; 18; 34; 29 | — |
| PRIMARY Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 12 |
5; 5; 28; 26 | — |
| PRIMARY Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 18 |
3; 7; 25; 26 | — |
| PRIMARY Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 24 |
1; 2; 19; 20 | — |
| PRIMARY Kinetics of the ELISA IgG Antibody Rise in Serum |
— | — |
| SECONDARY ELISA GMC of Breast Milk IgA to Pertussis Toxin (PT) at Baseline. |
28.8 | — |
| SECONDARY ELISA GMC of Breast Milk IgA to PT at Week 2 |
5.0 | — |
| SECONDARY ELISA GMC of Breast Milk IgA to PT at Week 6 |
5.0 | — |
| SECONDARY ELISA GMC of Breast Milk IgA to PT at Month 6 |
5.0 | — |
| SECONDARY ELISA GMC of Breast Milk IgA to FHA at Baseline. |
28.3 | — |
| SECONDARY ELISA GMC of Breast Milk IgA to FHA at Week 2. |
5.4 | — |
| SECONDARY ELISA GMC of Breast Milk IgA to FHA at Week 6. |
5.0 | — |
| SECONDARY ELISA GMC of Breast Milk IgA to FHA at Month 6. |
5.2 | — |
| SECONDARY ELISA GMC of Breast Milk IgA to PRN and FIM by Study Day. |
— | — |
| SECONDARY Proportion of Participants With 4-fold Rise in Antibody in Breast Milk by Study Day. |
— | — |
| SECONDARY Geometric Mean Fold Rise in Antibody Concentrations Assessed by ELISA in Breast Milk by Study Day |
— | — |
| SECONDARY Kinetics of the ELISA IgG Antibody Decline in Breast Milk Expressed in EU/ml. |
— | — |
Summary
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01711645). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.