[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Canadian Immunization Research Network\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":103},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,75],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100600401","phase-4-concurrent-versus-sequential-administration-of-tdap-and-rsv-vaccines-in-pregnancy-100600401",false,"NCT07097012","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","CosTaR","Inclusion Criteria\n\n1. Healthy pregnant individuals with a singleton pregnancy aged 18-49 years.\n2. 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.\n3. 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).\n4. Informed consent read, understood and signed prior to study-specific procedures.\n\nExclusion Criteria\n\nAny of the following:\n\n1. Receipt of RSV vaccine anytime.\n2. Receipt of immunoglobulins (except Rho D) within 1 year prior to vaccination.\n3. Documented receipt of pertussis vaccine within 2 years prior to vaccination.\n4. Documented pertussis infection (by culture or polymerase chain reaction) within 2 years prior to vaccination.\n5. Receipt of blood transfusion products within 6 months prior to vaccination.\n6. Primary or secondary immunologic disorder or immunosuppression.\n7. 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.\n8. Preconception diabetes mellitus (defined as: previous diagnosis of diabetes while not pregnant OR First trimester hemoglobin A1c level of 6.5% \\[47.5 mmol\u002Fmol\\] OR First trimester fasting blood glucose 126 mg\u002FdL \\[7 mmol\u002FL\\]).\n9. 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).\n10. Congenital anomalies per ultrasound.\n11. Hepatitis B infection; Hepatitis C infection; Untreated syphilis.\n12. 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\u002For tetanus.\n13. Contraindication to receipt of RSVpreF (ABRYSVOTM, Pfizer): Hypersensitivity to the active substance or to any component of the vaccine.\n14. Pregnancy complications at the time of recruitment that are risk factors for preterm delivery:\n\n    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);\n    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;\n    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\u002FdL \\[5.1-6.9 mmol\u002Fl\\] using venous or capillary blood samples;\n    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\\]);\n    5. Placenta anomalies (placenta previa and abruptio, vasa previa);\n    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);\n    7. Oligohydramnios (decreased amniotic fluid volume as defined in d above);\n    8. Short uterine cervix (\\\u003C25 mm in the second trimester of pregnancy);\n    9. A significant acute disease or oral temperature ≥38 Co within 24 hours prior to vaccination. Participants can return for evaluation to be randomized\u002Fvaccinated 72 hours after symptoms resolve, if they are still within 28-29+6 WG.","FEMALE","18 Years","49 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","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.\n\nThe Main question:\n\n-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?\n\nThe Secondary question:\n\n-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.\n\nThe Exploratory (optional participation) questions:\n\n* 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.\n* 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.\n* 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.\n\nParticipants 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).\n\nThere are 4 visits as part of the main study, and 6 additional visits as part of the optional study (exploratory questions).\n\nVisit 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).\n\nParticipants will be asked to keep a diary of symptoms throughout the study.",[28,29,30,31],"RSV","Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination","Pregnancy","Healthy",[28,33,30,34,35],"Tdap","Clinical trial","Vaccine","RECRUITING","2026-06-14",{"date":39,"type":40},"2026-06-16","ACTUAL",{"date":42,"type":40},"2025-10-16",{"date":44,"type":22},"2027-10",{"name":46,"class":47},"Canadian Immunization Research Network","NETWORK",4,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":57,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100553736","addressing-unfunded-vaccines-through-a-co-payment-mechanism-in-pharmacies-100553736","NCT06489964","Addressing Unfunded Vaccines Through a Co-payment Mechanism in Pharmacies","Addressing the Problem of Recommended But Unfunded Vaccines Through a Co-payment Mechanism in Pharmacies","Inclusion Criteria:\n\n* Community Pharmacy Sites: Inclusion criteria for the selection of the community pharmacies will include volume of prescriptions (e.g., how busy the site it), stable pharmacy patients (e.g., patients who consistently use the same pharmacy), availability and interest of community pharmacies and community pharmacy professionals, sufficient numbers of pharmacy professionals qualified to provide vaccinations, and lack of substantial health care spill over to adjacent communities. Spill over is defined as a pattern of health-care utilization where the public regularly receive care at different regional health centres. Communities will be geographically separated to minimize potential spill over. Based on this inclusion criteria, one pharmacy from the four health zones in Nova Scotia will be selected to implement the co-payment model within their community pharmacy, while a mix of urban and rural pharmacies in Ontario will be selected to implement the co-payment model.\n* Members of the Public: The participating pilot pharmacies will recruit through targeted screening members of the public who meet the vaccine-specific eligibility criteria or their substitute decision-makers for those who lack capacity to consent. Any members of the public or the substitute decision-maker who consents to participate will be eligible until the maximum number of participants we aim to recruit has been achieved. Eligible members of the public will receive the vaccines based on NACI recommendations for each product as part of routine care.\n* Recommended but Unfunded Vaccines: FluMist Quadrivalent: An age-appropriate quadrivalent influenza should be used in children (2 to 17 years) without contraindications or precautions; Shingrix Vaccine: Adults 50 to 64 years of age in Nova Scotia or 50 years of age or older in Ontario without contraindications or adults 18 years of age or older if immunocompromised; and Abrysvo or Arexvy (RSV) vaccine: Adults 50 years of age or older (Arexvy) or 60 years of age and older (Abrysvo) who are at increased risk of severe RSV disease. Note: The eligibility criteria for each vaccine product may be revised during the pilot study if there are any changes in vaccine recommendations and\u002For funding status in Nova Scotia or Ontario.\n\nExclusion Criteria:\n\n* FluMist Quadrivalent: should not be used in children or adolescents for whom it is contraindicated or for whom there are warnings and precautions; should not be used in children or adolescents already adequately immunized against influenza; not recommended for pregnant individuals, health care workers, and adult 18 to 59 years old with specific chronic health conditions; adults 60 to 64 and 65 years and old, as this vaccine is not authorized for use in these age groups; pediatric children (2 to 17 years) of the participating pharmacies who already have private insurance coverage to cover all (or most) of the FluMist vaccine will be excluded from taking part in this study.\n* Shingrix: Persons with active herpes zoster (HZ) should not be immunized with HZ vaccine; should not be used in individuals already adequately immunized against HZ; adults 65 years of age or older in Nova Scotia, as this vaccine is publicly funded for this age group; adults 65 to 70 years of age in Ontario, as this vaccine is publicly funded for this age group; and adults (50 to 64 years old in Nova Scotia and 50 years of age or older in Ontario) of the participating pharmacies who already have private insurance coverage to cover all (or most) of the Shingrix vaccine will be excluded from taking part in this study.\n* Abrysvo or Arexvy (RSV): Persons under the age 50 years should not be immunized with RSV vaccine (exception is use of Abrysvo in pregnancy), as it is not authorized for use in this age group; should not be used in individuals already adequately immunized against RSV; adults 60 years and older in Nova Scotia living in long-term care facilities or in hospital awaiting long-term care placement, as this vaccine is publicly funded for this age group; high-risk older adults (aged 60 years and older) in Ontario (e.g., residents of long-term care homes, Elder Care Lodges, or retirement homes; patients in hospital receiving alternate level of care; patients receiving hemodialysis or peritoneal dialysis; recipients of solid organ or hematopoietic stem cell transplants; individuals experiencing homelessness; and individuals who identify as First Nations, Inuit, or Métis); and adults (≥ 50 years of age (AREXVY) or 60 years of age (Abrysvo) at increased risk of severe RSV disease) of the participating pharmacies who already have private insurance coverage to cover all (or most) of the RSV vaccine will be excluded from taking part in this study.",true,"ALL","2 Years",{"count":60,"type":22},600,[62],"NA","The goal of this pilot demonstration and evaluation project is to determine the acceptability and feasibility of a co-payment model among the public and providers and assess whether a co-payment model in community pharmacies in Nova Scotia and Ontario increases the accessibility and uptake of recommended but unfunded vaccines. The research questions that guided the development of this study are:\n\n* What is the feasibility of implementing a co-payment model for recommended but unfunded vaccines in community pharmacies?\n* To what extent is a co-payment model for recommended but unfunded vaccines perceived as acceptable to community pharmacists and the public?\n\nA co-payment model will be piloted at a maximum of 8 select community pharmacy sites in Nova Scotia (n=4 sites) and Ontario (n=4 sites). Each community pharmacy site will be randomly assigned to pilot one of the steps of the co-payment model for the duration of the demonstration project. At the end of the pilot study, participating pharmacy providers will be asked to complete an online survey about their experiences in implementing the co-payment model into their pharmacy. As part of the co-payment model, recruited members of the public (participants) will choose to receive the vaccine (if eligible) at a reduced cost either for themselves or their dependent (e.g., incapable minor or adult), as part of routine care (following standard pharmacy practice). After receiving the vaccine, the participant will complete an online survey exploring their thoughts on the co-payment model, their satisfaction with the co-payment model, their perception on vaccines in general, and their demographics (such as gender, age, education, race\u002Fethnicity).",[65],"Preventable Disease, Vaccine","2026-03-18",{"date":68,"type":40},"2026-03-19",{"date":70,"type":40},"2025-10-23",{"date":72,"type":22},"2026-12",{"name":46,"class":47},2,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":56,"sex":57,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":23,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},"100604943","phase-4-persistence-of-immune-response-six-years-after-one-dose-of-9vhpv-vaccine-among-male-and-female-students-100604943","NCT07156084","Persistence of Immune Response Six Years After One Dose of 9vHPV Vaccine Among Male and Female Students","CIRN-HPV-ONE","Inclusion Criteria:\n\n* Have received a single dose of 9vHPV vaccine at ages 9-11 during the school year 2019-2020;\n* Not have received any other HPV vaccine doses;\n* Be able to consent to the study.\n\nExclusion Criteria:\n\n* Immunosuppressed (at recruitment or when immunized).","15 Years","17 Years",{"count":85,"type":22},300,[25],"Since the 2019-2020 school year, the province of Quebec (Canada) has been administering one dose of nonavalent (9vHPV) vaccine to students of all genders in Grade 4 of elementary school through the school-based program.\n\nLittle data on the immunogenicity (antibody production) and long-term efficacy of a single dose of the vaccine are available, particularly in boys.\n\nThe primary objective of this study is to assess the persistence of HPV antibodies six years after the administration of a single dose of the 9vHPV vaccine to students aged 9 to 11 years in Grade 4 in 2019-2020.\n\nThe study will be conducted at the CHU de Québec-Université Laval research center.\n\nRecruitment is conducted through school service centers in the Quebec City region. Youth who received only a single dose of the 9vHPV vaccine at the ages of 9-11 in 2019-2020 will be eligible to participate.\n\nApproximately 300 youth will take part in this study: 150 girls and 150 boys.\n\nParticipants will have to answer few questions about their health to ensure their eligibility for the study. For eligible participants consenting to participate a 10 ml (\\\u003C1 tablespoon) blood sample will be taken.",[89],"HPV Vaccine",[91,92,93],"HPV","Vaccination","Schedule","2025-09-24",{"date":96,"type":40},"2025-09-29",{"date":98,"type":40},"2025-09-23",{"date":100,"type":22},"2026-02",{"name":46,"class":47},1,""]