Actively Recruiting
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
Led by Canadian Immunization Research Network · Updated on 2026-03-12
60
Participants Needed
4
Research Sites
102 weeks
Total Duration
On this page
Sponsors
C
Canadian Immunization Research Network
Lead Sponsor
O
Ottawa Hospital Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. The Main question: -Is it possible to run a successful trial that tests how safe and effective it is to give Tdap and RSV vaccines in pregnancy either at the same time or one after the other, at different visits? The Secondary question: -To determine how safe and how well the Tdap and RSV vaccines work when given in pregnancy either at the same time or one after the other, at different visits. The Exploratory (optional participation) questions: * To measure the levels of antibodies against whooping cough (pertussis) and RSV in mothers at 7 and 19 months after giving birth, depending on whether they got the vaccines at the same time or one after the other during pregnancy. * To measure whooping cough antibody levels in the babies at 2, 7, and 19 months of age, whose mothers who received the vaccines in pregnancy. * To measure the levels of RSV antibodies in the mothers' breast milk at 1 week, 2 weeks, 4 weeks, and 2 months after giving birth. Participants will be randomly assigned to Group 1 (vaccines given at the same time, same visit) or Group 2 (vaccines given one after the other, at different visits). There are 4 visits as part of the main study, and 6 additional visits as part of the optional study (exploratory questions). Visit 1-2: Blood collection and vaccines administered Visit 3-4: Blood work (cord blood sample collection from infant, after delivery, if possible) Visit 5-8: Breast milk collection Visit 8-10: Blood collection (infant blood collection only at Visit 8). Participants will be asked to keep a diary of symptoms throughout the study.
CONDITIONS
Official Title
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy pregnant individuals aged 18 to 49 years with a single pregnancy
- Gestational age 28 to 29 weeks plus 6 days at screening and enrollment based on early ultrasound or last menstrual period
- Able to follow study procedures needed for the main trial objectives
- Able to provide informed consent before any study-related procedures
You will not qualify if you...
- Previous receipt of RSV vaccine at any time
- Receipt of immunoglobulins (except Rho D) within 1 year before vaccination
- Pertussis vaccine received within 2 years before vaccination
- Pertussis infection diagnosed within 2 years before vaccination
- Blood transfusion products received within 6 months before vaccination
- Immunologic disorders or immunosuppression
- Conditions interfering with study compliance or prenatal care, such as behavioral or cognitive issues
- Preconception diabetes mellitus as defined by diagnosis or blood test results
- Preconception chronic hypertension diagnosed before pregnancy or before 20 weeks gestation
- Congenital anomalies detected by ultrasound
- Hepatitis B or C infection or untreated syphilis
- Contraindications to Tdap vaccine including hypersensitivity or neurological complications
- Contraindications to RSVpreF vaccine including hypersensitivity
- Pregnancy complications that increase risk of preterm delivery, such as gestational hypertension, pre-eclampsia, uncontrolled gestational diabetes, fetal growth restriction, placenta anomalies, polyhydramnios, oligohydramnios, short uterine cervix
- Acute significant illness or fever ≥38°C within 24 hours before vaccination
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Vaccine Evaluation Center
Vancouver, British Columbia, Canada
Actively Recruiting
2
Canadian Center for Vaccinology
Halifax, Nova Scotia, Canada
Actively Recruiting
3
The Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Actively Recruiting
4
Centre hospitalier universitaire Ste-Justine
Montreal, Quebec, Canada
Actively Recruiting
Research Team
B
Bahaa Abu-Raya, M.D, PhD
CONTACT
C
CTN CIRN Central Inbox
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
2
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