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Compares treatment options for RSV
Official title Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
ClinicalTrials.gov ID: NCT07097012
What this study is testing
What is Tdap Vaccine Administration?
Tdap Vaccine Administration is an investigational medicine, being studied as a potential treatment for rsv.
Also referred to as BOOSTRIX, Tetanus-diphtheria-acellular pertussis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn if the RSV vaccine (protects against respiratory syncytial virus) and Tdap vaccine (protects against pertussis) are most effective in pregnant individuals when taken together at the same visit, or separately at different visits. This clinical trial will also learn about the safety and immune responses of these vaccines in pregnancy.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 49, women only
You may be able to join if
- Healthy pregnant individuals with a singleton pregnancy aged 18-49 years.
- Gestational age 28-29+6 WG at time of study screening, enrolment and randomization as per documented first trimester (less than or equal to13+6 WG)...
- Able to comply with the study procedures required to achieve primary objective of this pilot trial (not being able to comply with procedures required...
You likely can't join if
- Informed consent read, understood and signed prior to study-specific procedures. Exclusion Criteria Any of the following:
- Receipt of RSV vaccine anytime.
- Receipt of immunoglobulins (except Rho D) within 1 year prior to vaccination.
- Documented receipt of pertussis vaccine within 2 years prior to vaccination.
- Documented pertussis infection (by culture or polymerase chain reaction) within 2 years prior to vaccination.
- Receipt of blood transfusion products within 6 months prior to vaccination.
See the full eligibility criteria
- Healthy pregnant individuals with a singleton pregnancy aged 18-49 years.
- Gestational age 28-29+6 WG at time of study screening, enrolment and randomization as per documented first trimester (less than or equal to13+6 WG) ultrasound, or the first date of last menstrual period if ultrasound...
- Able to comply with the study procedures required to achieve primary objective of this pilot trial (not being able to comply with procedures required to achieve exploratory objectives is not an
- Informed consent read, understood and signed prior to study-specific procedures. Exclusion Criteria Any of the following:
- Receipt of RSV vaccine anytime.
- Receipt of immunoglobulins (except Rho D) within 1 year prior to vaccination.
- Documented receipt of pertussis vaccine within 2 years prior to vaccination.
- Documented pertussis infection (by culture or polymerase chain reaction) within 2 years prior to vaccination.
- Receipt of blood transfusion products within 6 months prior to vaccination.
- Primary or secondary immunologic disorder or immunosuppression.
- Any conditions that, in the investigator's judgement, may interfere with subject's ability to comply with study procedures or receipt of prenatal care, such as behavioural or cognitive impairment or neuropsychiatric...
- Preconception diabetes mellitus (defined as: previous diagnosis of diabetes while not pregnant OR First trimester hemoglobin A1c level of 6.5% [47.5 mmol/mol] OR First trimester fasting blood glucose 126 mg/dL [7...
- Preconception chronic hypertension (defined as: sustained elevation in the systolic blood pressure to ≥140 mmHg or the diastolic blood pressure to ≥90 mmHg, that is diagnosed either prior to pregnancy or prior to 20 WG).
- Congenital anomalies per ultrasound.
- Hepatitis B infection; Hepatitis C infection; Untreated syphilis.
- Contraindication to receipt of Tdap (BOOSTRIX, GSK): a) Hypersensitivity to any component of the Tdap (BOOSTRIX, GSK) vaccine or individuals having shown signs of hypersensitivity after previous administration of...
- Contraindication to receipt of RSVpreF (ABRYSVOTM, Pfizer): Hypersensitivity to the active substance or to any component of the vaccine.
- Pregnancy complications at the time of recruitment that are risk factors for preterm delivery:
- Gestational hypertension (defined as new onset hypertension after 20 WG of systolic blood pressure is ≥140 mmHg or the diastolic blood pressure is ≥90 mmHg on two measurements at a minimum of one hour apart);
- Pre-eclampsia (defined as development of gestational hypertension [as defined in #a above] and proteinuria after 20 WG (Proteinuria defined as ≥300 mg in a 24 h urine specimen, or ≥0.30 on a spot protein: creatinine...
- Gestational diabetes mellitus uncontrolled at time of consent (gestational diabetes is defined as a clinical syndrome characterized by the absence of preconception diabetes mellitus [as defined in #8 above] AND...
- Fetal growth restriction (defined as estimated fetal weight below 10% using locally-accepted growth curve AND Absent or reversed end-diastolic flow of the umbilical artery Doppler OR Oligohydramnios [defined as a...
- Placenta anomalies (placenta previa and abruptio, vasa previa);
- Polyhydramnios (defined as abnormal increase in the volume of amniotic fluid as either a deepest vertical pocket of ≥8 cm or an amniotic fluid index of ≥24 cm);
- Oligohydramnios (decreased amniotic fluid volume as defined in d above);
- Short uterine cervix (\<25 mm in the second trimester of pregnancy);
- A significant acute disease or oral temperature ≥38 Co within 24 hours prior to vaccination. Participants can return for evaluation to be assigned by chance/vaccinated 72 hours after symptoms resolve, if they are still...
The study team makes the final eligibility decision.
Where it's taking place
- Vancouver, British Columbia, Canada
- Halifax, Nova Scotia, Canada
- Ottawa, Ontario, Canada
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 49 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vancouver, British Columbia, Canada; Halifax, Nova Scotia, Canada; Ottawa, Ontario, Canada; Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.