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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy

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

Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy (NCT07097012) is a Phase 4 interventional studying RSV and Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination, sponsored by Canadian Immunization Research Network. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 60 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused RSV subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Inclusion Criteria 1. Healthy pregnant individuals with a singleton pregnancy aged 18-49 years. 2. 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. 3. 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). 4. willing to sign a consent form read, understood and signed prior to study-specific procedures. Exclusion Criteria Any of the following: 1. Receipt of RSV vaccine anytime. 2. Receipt of immunoglobulins (except Rho D) within 1 year prior to vaccination. 3. Documented receipt of pertussis vaccine within 2 years prior to vaccination. 4. Documented pertussis infection (by culture or polymerase chain reaction) within 2 years prior to vaccination. 5. Receipt of blood transfusion products within 6 months prior to vaccination. 6. Primary or secondary immunologic disorder or immunosuppression. 7. 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 illness. 8. 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 \[7 mmol/L\]). 9. 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). ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria 1. Healthy pregnant individuals with a singleton pregnancy aged 18-49 years. 2. 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. 3. 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). 4. Informed consent read, understood and signed prior to study-specific procedures. Exclusion Criteria Any of the following: 1. Receipt of RSV vaccine anytime. 2. Receipt of immunoglobulins (except Rho D) within 1 year prior to vaccination. 3. Documented receipt of pertussis vaccine within 2 years prior to vaccination. 4. Documented pertussis infection (by culture or polymerase chain reaction) within 2 years prior to vaccination. 5. Receipt of blood transfusion products within 6 months prior to vaccination. 6. Primary or secondary immunologic disorder or immunosuppression. 7. 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 illness. 8. 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 \[7 mmol/L\]). 9. 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). 10. Congenital anomalies per ultrasound. 11. Hepatitis B infection; Hepatitis C infection; Untreated syphilis. 12. 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 diphtheria, tetanus, or pertussis vaccines; b) Encephalopathy of unknown etiology, occurring within 7 days following previous vaccination with pertussis containing vaccine; c) Transient thrombocytopenia or neurological complications following an earlier immunization against diphtheria and/or tetanus. 13. Contraindication to receipt of RSVpreF (ABRYSVOTM, Pfizer): Hypersensitivity to the active substance or to any component of the vaccine. 14. Pregnancy complications at the time of recruitment that are risk factors for preterm delivery: 1. 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); 2. 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 ratio, or ≥1+ on a dipstick; 3. 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 identification of sustained hyperglycemia during pregnancy not due to other known causes (i.e. corticosteroids, beta-mimetics, etc.) based on positive internationally recognized oral glucose tolerance test OR fasting plasma glucose of 92-125 mg/dL \[5.1-6.9 mmol/l\] using venous or capillary blood samples; 4. 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 \[defined as a decreased amniotic fluid volume as defined by amniotic fluid index less than 8 cm or deepest vertical pocket less than 2 cm in the presence of intact membranes without concern for fetal anomalies contributing to its etiology\]); 5. Placenta anomalies (placenta previa and abruptio, vasa previa); 6. 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); 7. Oligohydramnios (decreased amniotic fluid volume as defined in d above); 8. Short uterine cervix (\<25 mm in the second trimester of pregnancy); 9. A significant acute disease or oral temperature ≥38 Co within 24 hours prior to vaccination. Participants can return for evaluation to be randomized/vaccinated 72 hours after symptoms resolve, if they are still within 28-29+6 WG.

Treatments Being Tested

BIOLOGICAL

Tdap Vaccine Administration

The Tdap vaccine will be administered according to the Product Monograph. Participants will be asked to look away during vaccine administration to maintain blinding.

BIOLOGICAL

RSV Vaccine

The RSVpreF vaccine will be administered according to the Product Monograph. Participants will be asked to look away during vaccine administration to maintain blinding.

OTHER

Saline (as a placebo)

Normal saline (0.5mL) will be administered as a placebo according to the Product Monograph. Participants will be asked to look away during vaccine administration to maintain blinding.

Locations (4)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Vaccine Evaluation Center
Vancouver, British Columbia, Canada
Canadian Center for Vaccinology
Halifax, Nova Scotia, Canada
The Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Centre hospitalier universitaire Ste-Justine
Montreal, Quebec, Canada

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07097012), the sponsor (Canadian Immunization Research Network), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07097012 clinical trial studying?

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 S… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07097012?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07097012?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07097012. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07097012. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.