Pertussis Maternal Immunization Study
Information source: Dalhousie University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pregnant Women
Intervention: Tdap (Biological); Td (Biological)
Phase: Phase 2/Phase 3
Status: Active, not recruiting
Sponsored by: Scott Halperin
Official(s) and/or principal investigator(s):
Scott A Halperin, MD, Principal Investigator, Affiliation: Dalhousie Univeristy - Canadian Center for Vaccinology
The purpose of this study is to assess whether immunization against pertussis in the mid
third trimester of pregnancy provides passive protection to the infant by transfer of IgG
transplacentally and by transfer of secretory IgA (and possibly IgG) in breast milk,
sufficient to protect the infant against pertussis disease in the critical neonatal period,
without suppressing the infant's immune response to active immunization and disease
Official title: Immunization of Women With Diphtheria and Tetanus Toxoids Combined With Acellular Pertussis (Tdap) During the Mid Third Trimester of Pregnancy: An Evaluation of the Potential for Immunological Protection for the Neonate
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Comparison of serum IgG antibody levels against PT, FHA, PRN, FIM between Tdap and Td groups
Secondary outcome: Safety of Tdap in pregnancy including pregnancy outcome and developmental assessment.
The purpose of this study is to assess the potential of providing initial immunological
protection to the neonate by providing passive placentally transferred serum antibodies and
breast milk antibodies against pertussis antigens (PT, FHA, PRN, FIM). This will be
- determining the rate of maternal antibody decline from time of immunization until 12
months postpartum by measuring antibody levels in serum, saliva, and breast milk at
- determining levels of antibody transferred to the neonate relative to the interval from
immunization to delivery;
- comparing levels of transplacentally transferred antibody with those achieved after the
first, second, and third dose of the primary immunization series; and
- determining whether maternal immunization interferes with active antibody production
following licensed DTaP-IPV-Hib in infants of women immunized during the mid third
trimester of pregnancy.
Minimum age: 18 Years.
Maximum age: N/A.
- Pregnant women 18 years of age and over.
- Women who, at ≥30-<32 weeks gestation, are at low risk for complications as
determined by the obstetrical algorithm for identification of eligible subjects and
the obstetrical risk assessment form.
- Signed, informed consent.
- Failure to meet eligibility criteria as determined by the obstetrical algorithm for
identification of eligible subjects and the obstetrical risk assessment form.
- History of significant medical disorder (such as bleeding disorders, cancer,
autoimmune disease, immunodeficiency (including HIV-infected individuals, transplant
recipients), seizure disorder or significant psychiatric illness, drug or alcohol
- Receipt of any high-dose daily corticosteroids (inhaled steroids are acceptable)
within 2 weeks of study entry. High dose is defined as a dose of ≥20 mg of prednisone
daily or equivalent.
- History of physician-diagnosed or laboratory-confirmed pertussis within the past 5
- Personal history (verbal or documented) of ever having received Tdap.
- Personal history (verbal or documented) of having received Td immunization within the
past 2 years.
- History of febrile illness (>37. 8ºC orally) within the past 72 hours (immunization
may be deferred).
- History of sensitivity to any component of Tdap.
- Receipt of blood products or immunoglobulin within 3 months of study entry (except
RH-negative women who receive immunoglobulin during pregnancy are eligible).
- Receipt of any vaccines within 2 weeks of study vaccine (except influenza vaccine
which may be given concurrently).
- Failure to give written, informed consent.
Locations and Contacts
Clinical Trial Research Center - Canadian Center for Vaccinology, Halifax, Nova Scotia B3K 6R8, Canada
Starting date: November 2007
Last updated: February 23, 2015