Pertussis Maternal Immunization Study
This study is ongoing, but not recruiting participants.
Sponsor:
Scott Halperin
Collaborators:
IWK Health Centre
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Scott Halperin, Dalhousie University
ClinicalTrials.gov Identifier:
NCT00553228
First received: November 2, 2007
Last updated: June 22, 2016
Last verified: June 2016
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Pregnant Women |
Biological: Tdap Biological: Td |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by Dalhousie University:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety of Tdap in pregnancy including pregnancy outcome and developmental assessment. [ Time Frame: developmental screening at 1 year of age ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 440 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00553228
Please refer to this study by its ClinicalTrials.gov identifier: 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
| Responsible Party: | Scott Halperin, Dr Scott Halperin, Dalhousie University |
| ClinicalTrials.gov Identifier: | NCT00553228 History of Changes |
| Other Study ID Numbers: | DAL07-01 |
| Study First Received: | November 2, 2007 |
| Last Updated: | June 22, 2016 |
| Health Authority: | Canada: Health Canada |
Keywords provided by 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 |
ClinicalTrials.gov processed this record on September 23, 2016