Study on the Safety and Immunogenicity of Boostrix Vaccine in Pregnant Malian Women and Their Infants
Condition: Clostridium Difficile Immunisation; Diphtheria; Diphtheria Immunisation; Pertussis; Tetanus; Tetanus Immunisation
MeSH terms: Tetanus; Diphtheria; Tetany
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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. The secondary
      objectives are: 1) to assess the antibody response to BOOSTRIX vaccine antigens in pregnant
      women one month after receipt of BOOSTRIX, at the time of delivery, and at 6 months after
      delivery; 2) to compare the antibody levels of BOOSTRIX vaccine antigens at birth (cord
      blood) and 6 weeks of age (before receiving any infant doses of Diphtheria, Tetanus, and
      whole-cell Pertussis (DTwP)) in infants whose mothers received BOOSTRIX or Td during
      pregnancy; 3) to assess placental antibody transfer by determining the ratio of maternal and
      infant BOOSTRIX -specific antibody responses at delivery; 4) to assess interference with
      infant antibody responses to DTwP either prior to the second dose of the primary DTwP series,
      at approximately 10 weeks of age (in 1/2 of subjects), or approximately one month after the
      third dose of the primary DTwP series, at approximately 18 weeks of age (in 1/2 of subjects),
      and at 6 months of age (all subjects).
    

Intervention name(s): Tetanus and Diphtheria Toxoids Adsorbed; Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum hydroxide
Intervention type(s): Biological; Biological
Intervention description(s): Used for active immunization of adults and children 7 years of age and older against diphtheria and tetanus.; A sterile isotonic suspension of tetanus and diphtheria toxoids and pertussis antigens adsorbed on Aluminum hydroxide.
Intervention MeSH terms: Aluminum Hydroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: BOOSTRIX; Immunogenicity; Infant; Mali; Phase II; Pregnant Women; Safety; Tdap