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Pertussis Maternal Immunization Study

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ClinicalTrials.gov Identifier: NCT00553228
Recruitment Status : Active, not recruiting
First Posted : November 5, 2007
Last Update Posted : June 23, 2016
Sponsor:
Collaborators:
IWK Health Centre
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Scott Halperin, Dalhousie University

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Pregnant Women Biological: Tdap Biological: Td Phase 2 Phase 3

Detailed Description:

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 accomplished by

  • 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 specified intervals;
  • 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : November 2007
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: group I
Tdap
 Biological: Tdap
0.5 mL IM once at visit #2
Other Name: Adacel
Active Comparator: group 2
Td
 Biological: Td
0.5 mL IM once at visit #2
Other Name: Diphtheria and tetanus toxoids, adsorbed


Outcome Measures
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Primary Outcome Measures :
  1. Comparison of serum IgG antibody levels against PT, FHA, PRN, FIM between Tdap and Td groups [ Time Frame: birth, 2, 4, 6, 7, 12, and 13 months of age ]

Secondary Outcome Measures :
  1. Safety of Tdap in pregnancy including pregnancy outcome and developmental assessment. [ Time Frame: developmental screening at 1 year of age ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 dependence).
  • 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 years.
  • 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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00553228


Locations
Canada, Nova Scotia
Clinical Trial Research Center - Canadian Center for Vaccinology
Halifax, Nova Scotia, Canada, B3K 6R8
Sponsors and Collaborators
Scott Halperin
IWK Health Centre
Sanofi Pasteur, a Sanofi Company
Investigators
Principal Investigator: Scott A Halperin, MD Dalhousie Univeristy - Canadian Center for Vaccinology
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Scott Halperin, Dr Scott Halperin, Dalhousie University
ClinicalTrials.gov Identifier: NCT00553228     History of Changes
Other Study ID Numbers: DAL07-01
First Posted: November 5, 2007    Key Record Dates
Last Update Posted: June 23, 2016
Last Verified: June 2016

Keywords provided by Scott Halperin, Dalhousie University:
maternal immunization
whooping cough
pertussis

Additional relevant MeSH terms:
Whooping Cough
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
 Infection
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs