Study on the Safety and Immunogenicity of Boostrix Vaccine in Pregnant Malian Women and Their Inf… (NCT03589768) | Clinical Trial Compass
CompletedPhase 2
Study on the Safety and Immunogenicity of Boostrix Vaccine in Pregnant Malian Women and Their Infants
United States, Mali399 participantsStarted 2019-01-24
Plain-language 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.
Who can participate
Age range
18 Years – 39 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Healthy pregnant woman 18-39 years of age, inclusive.
. Singleton fetus, with estimated gestational age of 14 0/7 through 26 6/7 weeks gestation, inclusive, on the day of study vaccination.
. Provide written consent after the nature of the study has been explained according to local regulatory requirements and prior to any study procedures\*.
. In good health as determined by medical history, targeted physical examination\* (physical examination performed as part of routine antenatal care of a study-specific brief exam may be used to determine eligibility), vital signs (oral temperature \< 37.8 degrees Celsius; pulse 55 to 100 beats per minute (bpm), inclusive; systolic blood pressure 90 to 140 millimeters of mercury (mm Hg), inclusive; diastolic blood pressure 55 to 90 mm Hg, inclusive), and clinical judgment of the investigator.
. Ability to comprehend and comply with all study procedures, as determined by the investigator determining eligibility, and availability for follow-up.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Pregnant Women Reporting Related Serious Adverse Events (SAEs) and Unrelated SAEs
Timeframe: Study Day 1 through Day 180 (6-months post-partum)
2
Number of Pregnant Women Reporting Pregnancy-Specific Adverse Events (AEs)
Timeframe: Study Day 1 through Day 180 (6-months post-partum)
3
Number of Infants Reporting Related SAEs and Unrelated SAEs
Timeframe: Birth Day through 6 months of age
4
Number of Infants Reporting Pregnancy-specific AEs
Timeframe: Birth Day through 6 months of age
5
Number of Pregnant Women Reporting Solicited Injection Site and Systemic Reactogenicity Events
Timeframe: Pre-Dose Day 1, Post-Dose Day 1, Day 4, Day 8
6
Number of Pregnant Women Reporting Unsolicited Non-serious AEs
Timeframe: Day 1 through Day 31
7
Geometric Mean Concentration (GMC) of Serum IgG Antibodies to Pertussis Toxin (PT) in Infants Born to Women Receiving BOOSTRIX or Td
Trial details
NCT IDNCT03589768
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. Willing to allow study staff to gather pertinent medical information, including pregnancy outcome data and medical information about her infant.
Exclusion criteria
. History of illness or an ongoing illness that, in the opinion of the investigator, may pose additional risk to the subject or her fetus if she participates in the study.
. Infection requiring systemic antibiotics or antiviral treatment within the 7 days prior to study vaccination.
. Fever (oral temperature \> / = 37.8 degrees Celsius/100.0 degrees Fahrenheit) or other acute illness within 3 days prior to study vaccination\*.
. Known active neoplastic disease (excluding non-melanoma skin cancer), anticancer chemotherapy, or radiation therapy (cytotoxic) within 3 years prior to study vaccination.
. History of any hematologic malignancy at any time.
. A history of a serious adverse event following previous immunizations (e.g., Bell's Palsy, Guillain-Barre Syndrome, encephalopathy), or history of progressive neurologic disorders.
. Known or suspected disease that impairs the immune system including known or suspected HIV infection or HIV-related disease.
. Receipt of immunosuppressive therapy, including long-term use of glucocorticoids: oral, inhaled, intranasal or parenteral prednisone \> / = 20 mg/day or equivalent for more than 2 weeks within the 30 days prior to enrollment. Use of topical corticosteroids is allowed.
Timeframe: Birth Day, Prior to receipt of first dose of DTwP (approximately 6 weeks of age), One month after receipt of first dose of DTwP (approximately 10 weeks of age), One month after receipt of last dose of DTwP (approximately 18 weeks of age), 6 months of age