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Study on the Safety and Immunogenicity of Boostrix Vaccine in Pregnant Malian Women and Their Infants

NCT03589768 PHASE2 COMPLETED Results posted

This is a phase II, randomized, double-blind, active-controlled study to evaluate the safety, immunogenicity, and effect on infant immune responses of a single dose of Tetanus diphtheria acellular pertussis vaccine (Tdap) in pregnant women in Mali. 200 healthy pregnant women, ages 18 through 39 years, inclusive, who meet all eligibility criteria will be randomly allocated in a 2:1 ratio to receive either Tdap (BOOSTRIX) or Tetanus diphtheria toxoid (Td) at 14 0/7 weeks through 26 6/7 weeks estimated Gestational Age (GA). For the fetuses of pregnant subjects, GA will be established by ultrasound, whenever possible, in combination with date of last menstrual period (LMP), when available, and fundal height. Study duration is 21 months: approximately 2 months in the start-up period, 6 months enrolling subjects, and 13 months (3-7 months while pregnant and 6 months postpartum) from last subject vaccinated until she and her infant complete follow-up. The primary objectives of this study are: 1) to assess the safety and tolerability of a single 0.5 mL intramuscular injection of BOOSTRIX in pregnant women; 2) to assess the safety of a single maternal BOOSTRIX vaccination on the fetus and infant; 3) to assess the level of Pertussis Toxin (PT) antibody at birth among infants whose mothers received a single dose of BOOSTRIX or Td while pregnant.

Details

Lead sponsorNational Institute of Allergy and Infectious Diseases (NIAID)
PhasePHASE2
StatusCOMPLETED
Enrolment399
Start dateThu Jan 24 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
CompletionWed Jul 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Interventions

Countries

United States, Mali