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NCT03589768 · ClinicalTrials.gov registry record · Phase 2
Study on the Safety and Immunogenicity of Boostrix Vaccine in Pregnant Malian Women and Their Infants
A Phase 2 study of Diphtheria and Tetanus, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 399
- Enrollment target
- 2
- Study locations
NCT03589768: Completed Phase 2 study of Diphtheria and Tetanus, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03589768 is a Phase 2 study of Diphtheria and Tetanus that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 399 participants, below the 1,840-participant average among 15 other Diphtheria trials with a reported enrollment target (78% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03589768, a Phase 2 study of Diphtheria and Tetanus, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 399 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect. All SAEs were reported from time of first study vaccination through approximately 6 months after the first study vaccination
Conditions Studied
Interventions
- BIOLOGICAL Tetanus and Diphtheria Toxoids Adsorbed
- BIOLOGICAL Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum hydroxide
Study Locations (2)
Maryland
- University of Maryland, School of Medicine, Center for Vaccine Development and Global Health - Baltimore
Other
- Center for Vaccine Development - Mali - Bamako
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 399 participants |
| Start Date | 2019-01-24 |
| Est. Completion | 2020-07-01 |
| Phase | Phase 2 |
What the finished NCT03589768 record still lists
NCT03589768 is an interventional study that assigns participants to a tested intervention. The registered 399 participants enrollment target is mid-sized for trials with a published cap, below the 1,840-participant average among 15 other Diphtheria trials with a reported enrollment target (78% lower).
The record links to 6 conditions, with Diphtheria appearing as the primary indexed condition, and to 2 interventions - of which Tetanus and Diphtheria Toxoids Adsorbed is the first listed.
NCT03589768 reports a single indexed study location in Maryland, Other.
Frequently Asked Questions
What is clinical trial NCT03589768 about?
NCT03589768 is a clinical study titled "Study on the Safety and Immunogenicity of Boostrix Vaccine in Pregnant Malian Women and Their Infants". 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 year...
What is the current status of trial NCT03589768?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 399 participants. The study started on 2019-01-24. Estimated completion is 2020-07-01.
What conditions does trial NCT03589768 study?
This clinical trial studies the following conditions: Diphtheria, Tetanus, Pertussis, Diphtheria Immunisation, Tetanus Immunisation.
What interventions are being tested in trial NCT03589768?
The interventions under investigation include: Tetanus and Diphtheria Toxoids Adsorbed (BIOLOGICAL), Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum hydroxide (BIOLOGICAL).
Who is sponsoring clinical trial NCT03589768?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03589768 being conducted?
This trial has 2 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03589768's enrollment target sits among peer trials
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