NCT00553228

Pertussis Maternal Immunization Study

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: Scott Halperin · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

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.

Conditions

• Pregnant Women

Interventions

Type	Name	Description
BIOLOGICAL	Tdap	0.5 mL IM once at visit #2
BIOLOGICAL	Td	0.5 mL IM once at visit #2

Timeline

• Start date: 2007-11-01
• Primary completion: 2015-12-09
• Completion: 2015-12-09
• First posted: 2007-11-05
• Last updated: 2020-08-27

Locations

1 site across 1 country: Canada