Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy - A Pilot Feasibility Trial

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 49
Healthy Volunteers: f
View:

• 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 not obtained in the first trimester, or the age of the embryo and the date of transfer if pregnancy resulted from assisted reproductive technology.

• 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 exclusion criteria).

• Informed consent read, understood and signed prior to study-specific procedures.

Locations
Other Locations
Canada
Canadian Center for Vaccinology
RECRUITING
Halifax
Centre hospitalier universitaire Ste-Justine
NOT_YET_RECRUITING
Montreal
The Ottawa Hospital Research Institute
NOT_YET_RECRUITING
Ottawa
Vaccine Evaluation Center
RECRUITING
Vancouver
Contact Information
Primary
Bahaa Abu-Raya, M.D, PhD
bh723616@dal.ca
(902) 470-8142
Backup
CTN CIRN Central Inbox
CTN.CIRN@iwk.nshealth.ca
Time Frame
Start Date: 2025-10-16
Estimated Completion Date: 2027-10
Participants
Target number of participants: 60
Treatments
Active_comparator: Group 1: Concurrent Assignment
Active_comparator: Group 2: Sequential Assignment
Related Therapeutic Areas
Sponsors
Collaborators: Public Health Agency of Canada (PHAC), Canadian Center for Vaccinology, IWK Health Centre, Dalhousie University, Centre Hospitalier Univeritaire Sainte Justine, University of British Columbia, Ottawa Hospital Research Institute, Vaccine Evaluation Center, Canada
Leads: Canadian Immunization Research Network

This content was sourced from clinicaltrials.gov