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 range18 Years – 39 Years
SexFEMALE
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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.
✓. Willing to allow study staff to gather pertinent medical information, including pregnancy outcome data and medical information about her infant.
Exclusion criteria
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
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
Trial details
NCT IDNCT03589768
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. 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.